ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 09:00 QMS A Scope of Certification (inc: ANNEX I.14.2 Devices shall be designed and manufactured in such a way as to remove or reduce
Review of Device Master as far as possible:
Schedule, Device Groups,
Type Testing, (a) the risk of injury, in connection with their physical features, including the
Nanoparticles, Software, volume/pressure ratio, dimensional and where appropriate ergonomic features;
Reprocessing, parts/
component as a device, (b) risks connected with reasonably foreseeable external influences or
Human/Animal tissue, environmental conditions, such as magnetic fields, external electrical and
Medicinal substances, electromagnetic effects, electrostatic discharge, radiation associated with
Procedure Packs, Class I) diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in
pressure and acceleration or radio signal interferences;

(c) the risks associated with the use of the device when it comes into contact with
materials, liquids, and substances, including gases, to which it is exposed during
normal conditions of use;

(d) the risks associated with the possible negative interaction between software and
the IT environment within which it operates and interacts;

(e) the risks of accidental ingress of substances into the device;

(f) the risks of reciprocal interference with other devices normally used in the
investigations or for the treatment given; and

(g) risks arising where maintenance or calibration are not possible (as with
implants), from ageing of materials used or loss of accuracy of any measuring or
control mechanism.

A ANNEX I.17 Electronic programmable systems — devices that incorporate electronic NA

programmable systems and software that are devices in themselves

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 1 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A ANNEX I.23.4 23.4. Information in the instructions for use

The instructions for use shall contain all of the following particulars:
(a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section
23.2;
(b) the device's intended purpose with a clear specification of indications, contra-
indications, the patient target group or groups, and of the intended users, as
appropriate;
(c) where applicable, a specification of the clinical benefits to be expected.
(d) where applicable, links to the summary of safety and clinical performance
referred to in Article 32;
(e) the performance characteristics of the device;
(f) where applicable, information allowing the healthcare professional to verify if
the device is suitable and select the corresponding software and accessories;
(g) any residual risks, contra-indications and any undesirable side-effects, including
information to be conveyed to the patient in this regard;
(h) specifications the user requires to use the device appropriately, e.g. if the device
has a measuring function, the degree of accuracy claimed for it;
(i) details of any preparatory treatment or handling of the device before it is ready
for use or during its use, such as sterilisation, final assembly, calibration, etc.,
including the levels of disinfection required to ensure patient safety and all
available methods for achieving those levels of disinfection;
(j) any requirements for special facilities, or special training, or particular
qualifications of the device user and/or other persons;
(k) the information needed to verify whether the device is properly installed and is
ready to perform safely and as intended by the manufacturer, together with, where
relevant:

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 2 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A ANNEX IX 1. The manufacturer shall establish, document and implement a quality

management system as described in Article 10(9) and maintain its effectiveness
throughout the life cycle of the devices concerned. The manufacturer shall ensure
the application of the quality management system as specified in Section 2 and shall
be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as
specified in Section 3.
2. Quality management system assessment
2.1. The manufacturer shall lodge an application for assessment of its quality
management system with a notified body. The application shall include:
— the name of the manufacturer and address of its registered place of business and
any additional manufacturing site covered by the quality management system, and,
if the manufacturer's application is lodged by its authorised representative, the
name of the authorised representative and the address of the authorised
representative's registered place of business,

A ANNEX IX.2.4 2.4. The manufacturer in question shall inform the notified body which approved
the quality management system of any plan for substantial changes to the quality
management system, or the device-range covered. The notified body shall assess
the changes proposed, determine the need for additional audits and verify whether
after those changes the quality management system still meets the requirements
referred to in Section 2.2. It shall notify the manufacturer of its decision which shall
contain the conclusions of the assessment, and where applicable, conclusions of
additional audits. The approval of any substantial change to the quality
management system or the device-range covered shall take the form of a
supplement to the EU quality management system certificate.

A ANNEX IX.5.2 5.2. Procedure in the case of devices incorporating a medicinal substance
(a) Where a device incorporates, as an integral part, a substance which, if used
separately, may be considered to be a medicinal product within the meaning of
point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived
from human blood or human plasma and that has an action ancillary to that of the
device, the quality, safety and usefulness of the substance shall be verified by
analogy with the methods specified in Annex I to Directive 2001/83/EC.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 3 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A ANNEX IX.5.3 5.3. Procedure in the case of devices manufactured utilising, or incorporating, NA
tissues or cells of human or animal origin, or their derivatives, that are non-viable or
rendered non-viable

A Annex X 1. EU type-examination is the procedure whereby a notified body ascertains and

certifies that a device, including its technical documentation and relevant life cycle
processes and a corresponding representative sample of the device production
envisaged, fulfils the relevant provisions of this Regulation.

A Annex XIII.1 1. For custom-made devices, the manufacturer or its authorised representative
shall draw up a statement containing all of the following information:
— the name and address of the manufacturer, and of all manufacturing sites,

A Annex XIII.2 2. The manufacturer shall undertake to keep available for the competent national
authorities documentation that indicates its manufacturing site or sites and allows
an understanding to be formed of the design, manufacture and performance of the
device, including the expected performance, so as to allow assessment of
conformity with the requirements of this Regulation.

A Annex XIII.3 3. The manufacturer shall take all the measures necessary to ensure that the
manufacturing process produces devices which are manufactured in accordance
with the documentation referred to in Section 2.

A Annex XIII.4 4. The statement referred to in the introductory part of Section 1 shall be kept for a
period of at least 10 years after the device has been placed on the market. In the
case of implantable devices, the period shall be at least 15 years.

A Annex XIII.5 Section 8 of Annex IX shall apply.

5. The manufacturer shall review and document experience gained in the post-
production phase, including from PMCF as referred to in Part B of Annex XIV, and
implement appropriate means to apply any necessary corrective action, In that
context, it shall report in accordance with Article 87(1) to the competent authorities
any serious incidents or field safety corrective actions or both as soon as it learns of
them.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 4 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Annex XVI LIST OF GROUPS OF PRODUCTS WITHOUT AN INTENDED MEDICAL PURPOSE

REFERRED TO IN ARTICLE 1(2)
1. Contact lenses or other items intended to be introduced into or onto the eye.
2. Products intended to be totally or partially introduced into the human body
through surgically invasive means for the purpose of modifying the anatomy or
fixation of body parts with the exception of tattooing products and piercings.

A Article 10 General obligations of manufacturers

1. When placing their devices on the market or putting them into service,
manufacturers shall ensure that they have been designed and manufactured in
accordance with the requirements of this Regulation.
2. Manufacturers shall establish, document, implement and maintain a system for
risk management as described in Section 3 of Annex I.
3. Manufacturers shall conduct a clinical evaluation in accordance with the
requirements set out in Article 61 and Annex XIV, including a PMCF.
4. Manufacturers of devices other than custom-made devices shall draw up and
keep up to date technical documentation for those devices. The technical
documentation shall be such as to allow the conformity of the device with the
requirements of this Regulation to be assessed. The technical documentation shall
include the elements set out in Annexes II and III.
5. Manufacturers of custom-made devices shall draw up, keep up to date and keep
available for competent authorities documentation in accordance with Section 2 of
Annex XIII.
6. Where compliance with the applicable requirements has been demonstrated
following the applicable conformity assessment procedure, manufacturers of
devices, other than custom-made or investigational devices, shall draw up an EU
declaration of conformity in accordance with Article 19, and affix the CE marking of
conformity in accordance with Article 20.
7. Manufacturers shall comply with the obligations relating to the UDI system
referred to in Article 27 and with the registration obligations referred to in Articles
29 and 31.
8. Manufacturers shall keep the technical documentation, the EU declaration of
conformity and, if applicable, a copy of any relevant certificate, including any
amendments and supplements, issued in accordance with Article 56, available for
the competent authorities for a period of at least 10 years after the last device
covered by the EU declaration of conformity has been placed on the market. In the
case of implantable devices, the period shall be at least 15 years after the last
device has been placed on the market.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 5 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 17 Single-use devices and their reprocessing

1. Reprocessing and further use of single-use devices may only take place where
permitted by national law and only in accordance with this Article.
2. Any natural or legal person who reprocesses a single-use device to make it
suitable for further use within the Union shall be considered to be the
manufacturer of the reprocessed device and shall assume the obligations
incumbent on manufacturers laid down in this Regulation, which include obligations
relating to the traceability of the reprocessed device in accordance with Chapter III
of this Regulation. The reprocessor of the device shall be considered to be a
producer for the purpose of Article 3(1) of Directive 85/374/EEC.
3. By way of derogation from paragraph 2, as regards single-use devices that are
reprocessed and used within a health institution, Member States may decide not to
apply all of the rules relating to manufacturers' obligations laid down in this
Regulation provided that they ensure that:
(a) the safety and performance of the reprocessed device is equivalent to that of
the original device and the requirements in points (a), (b), (d), (e), (f), (g) and (h) of
Article 5(5) are complied with;
(b) the reprocessing is performed in accordance with CS detailing the requirements
concerning:
— risk management, including the analysis of the construction and material, related
properties of the device (reverse engineering) and procedures to detect changes in
the design of the original device as well as of its planned application after
reprocessing,
— the validation of procedures for the entire process, including cleaning steps,
— the product release and performance testing,
— the quality management system,
— the reporting of incidents involving devices that have been reprocessed, and
— the traceability of reprocessed devices.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 6 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 22 Systems and procedure packs

1. Natural or legal persons shall draw up a statement if they combine devices
bearing a CE marking with the following other devices or products, in a manner that
is compatible with the intended purpose of the devices or other products and
within the limits of use specified by their manufacturers, in order to place them on
the market as a system or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with
Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those
products only where they are used within a medical procedure or their presence in
the system or procedure pack is otherwise justified.
2. In the statement made pursuant to paragraph 1, the natural or legal person
concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other
products, in accordance with the manufacturers' instructions and have carried out
their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information
to users incorporating the information to be supplied by the manufacturers of the
devices or other products which have been put together;
(c) the activity of combining devices and, if applicable, other products as a system
or procedure pack was subject to appropriate methods of internal monitoring,
verification and validation.
3. Any natural or legal person who sterilises systems or procedure packs referred to
in paragraph 1 for the purpose of placing them on the market shall, at their choice,
apply one of the procedures set out in Annex IX or the procedure set out in Part A
of Annex XI. The application of those procedures and the involvement of the
notified body shall be limited to the aspects of the procedure relating to ensuring
sterility until the sterile packaging is opened or damaged. The natural or legal
person shall draw up a statement declaring that sterilisation has been carried out in
accordance with the manufacturer's instructions.
4. Where the system or procedure pack incorporates devices which do not bear the
CE marking or where the chosen combination of devices is not compatible in view
of their original intended purpose, or where the sterilisation has not been carried
out in accordance with the manufacturer's instructions, the system or procedure
pack shall be treated as a device in its own right and shall be subject to the relevant
conformity assessment procedure pursuant to Article 52. The natural or legal
A Article 23 Parts and components
1. Any natural or legal person who makes available on the market an item
specifically intended to replace an identical or similar integral part or component of
a device that is defective or worn in order to maintain or restore the function of the
device without changing its performance or safety characteristics or its intended
purpose, shall ensure that the item does not adversely affect the safety and
performance of the device. Supporting evidence shall be kept available for the
competent authorities of the Member States.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 7 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 29 Registration of devices

1. Before placing a device, other than a custom-made device, on the market, the
manufacturer shall, in accordance with the rules of the issuing entity referred to in
Article 27(2), assign a Basic UDI-DI as defined in Part C of Annex VI to the device and
shall provide it to the UDI database together with the other core data elements
referred to in Part B of Annex VI related to that device.
2. Before placing on the market a system or procedure pack pursuant to Article
22(1) and (3), that is not a custom-made device, the natural or legal person
responsible shall assign to the system or procedure pack, in compliance with the
rules of the issuing entity, a Basic UDI-DI and shall provide it to the UDI database
together with the other core data elements referred to in Part B of Annex VI related
to that system or procedure pack.
3. For devices that are the subject of a conformity assessment as referred to in
Article 52(3) and in the second and third subparagraphs of Article 52(4), the
assignment of a Basic UDI-DI referred to in paragraph 1 of this Article shall be done
before the manufacturer applies to a notified body for that assessment.
For the devices referred to in the first subparagraph, the notified body shall include
a reference to the Basic UDI-DI on the certificate issued in accordance with point (a)
of Section 4 of Chapter I of Annex XII and confirm in Eudamed that the information
referred to in Section 2.2 of Part A of Annex VI is correct. After the issuing of the
relevant certificate and before placing the device on the market, the manufacturer
shall provide the Basic UDI-DI to the UDI database together with the other core
data elements referred to in Part B of Annex VI related to that device.
4. Before placing a device on the market, other than a custom-made device, the
manufacturer shall enter or if, already provided, verify in Eudamed the information
referred to in Section 2 of Part A of Annex VI, with the exception of Section 2.2
thereof, and shall thereafter keep the information updated.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 8 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 30 Electronic system for registration of economic operators

1. The Commission, after consulting the MDCG, shall set up and manage an
electronic system to create the single registration number referred to in Article
31(2) and to collate and process information that is necessary and proportionate to
identify the manufacturer and, where applicable, the authorised representative and
the importer. The details regarding the information to be provided to that
electronic system by the economic operators are laid down in Section 1 of Part A of
Annex VI.
2. Member States may maintain or introduce national provisions on registration of
distributors of devices which have been made available on their territory.
3. Within two weeks of placing a device, other than a custom-made device, on the
market, importers shall verify that the manufacturer or authorised representative
has provided to the electronic system the information referred to in paragraph 1.
Where applicable, importers shall inform the relevant authorised representative or
manufacturer if the information referred to in paragraph 1 is not included or is
incorrect. Importers shall add their details to the relevant entry/entries.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 9 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 31 Registration of manufacturers, authorised representatives and importers

1. Before placing a device, other than a custom-made device, on the market,
manufacturers, authorised representatives and importers shall, in order to register,
submit to the electronic system referred to in Article 30 the information referred to
in Section 1 of Part A of Annex VI, provided that they have not already registered in
accordance with this Article. In cases where the conformity assessment procedure
requires the involvement of a notified body pursuant to Article 52, the information
referred to in Section 1 of Part A of Annex VI shall be provided to that electronic
system before applying to the notified body.
2. After having verified the data entered pursuant to paragraph 1, the competent
authority shall obtain a single registration number (‘SRN’) from the electronic
system referred to in Article 30 and issue it to the manufacturer, the authorised
representative or the importer.
3. The manufacturer shall use the SRN when applying to a notified body for
conformity assessment and for accessing Eudamed in order to fulfil its obligations
under Article 29.
4. Within one week of any change occurring in relation to the information referred
to in paragraph 1 of this Article, the economic operator shall update the data in the
electronic system referred to in Article 30.
5. Not later than one year after submission of the information in accordance with
paragraph 1, and every second year thereafter, the economic operator shall confirm
the accuracy of the data. In the event of a failure to do so within six months of
those deadlines, any Member State may take appropriate corrective measures
within its territory until that economic operator complies with that obligation.
6. Without prejudice to the economic operator's responsibility for the data, the
competent authority shall verify the confirmed data referred to in Section 1 of Part
A of Annex VI.
7. The data entered pursuant to paragraph 1 of this Article in the electronic system
referred to in Article 30 shall be accessible to the public.
8. The competent authority may use the data to charge the manufacturer, the
authorised representative or the importer a fee pursuant to Article 111.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 10 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 51 Classification of devices

1. Devices shall be divided into classes I, IIa, IIb and III, taking into account the
intended purpose of the devices and their inherent risks. Classification shall be
carried out in accordance with Annex VIII.
2. Any dispute between the manufacturer and the notified body concerned, arising
from the application of Annex VIII, shall be referred for a decision to the competent
authority of the Member State in which the manufacturer has its registered place of
business. In cases where the manufacturer has no registered place of business in
the Union and has not yet designated an authorised representative, the matter shall
be referred to the competent authority of the Member State in which the
authorised representative referred to in the last indent of point (b) of the second
paragraph of Section 2.2 of Annex IX has its registered place of business. Where the
notified body concerned is established in a Member State other than that of the
manufacturer, the competent authority shall adopt its decision after consultation
with the competent authority of the Member State that designated the notified
body.

A Article 52 Conformity assessment procedures

1. Prior to placing a device on the market, manufacturers shall undertake an
assessment of the conformity of that device, in accordance with the applicable
conformity assessment procedures set out in Annexes IX to XI.
2. Prior to putting into service a device that is not placed on the market,
manufacturers shall undertake an assessment of the conformity of that device, in
accordance with the applicable conformity assessment procedures set out in
Annexes IX to XI.
3. Manufacturers of class III devices, other than custom-made or investigational
devices, shall be subject to a conformity assessment as specified in Annex IX.
Alternatively, the manufacturer may choose to apply a conformity assessment as
specified in Annex X coupled with a conformity assessment as specified in Annex XI.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 11 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Article 86 Periodic safety update report

1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic
safety update report (‘PSUR’) for each device and where relevant for each category
or group of devices summarising the results and conclusions of the analyses of the
post-market surveillance data gathered as a result of the post-market surveillance
plan referred to in Article 84 together with a rationale and description of any
preventive and corrective actions taken. Throughout the lifetime of the device
concerned, that PSUR shall set out:
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF; and
(c) the volume of sales of the device and an estimate evaluation of the size and
other characteristics of the population using the device and, where practicable, the
usage frequency of the device.
Manufacturers of class IIb and class III devices shall update the PSUR at least
annually. That PSUR shall, except in the case of custom-made devices, be part of
the technical documentation as specified in Annexes II and III.

A Article 9 Common specifications

1. Without prejudice to Article 1(2) and 17(5) and the deadline laid down in those
provisions, where no harmonised standards exist or where relevant harmonised
standards are not sufficient, or where there is a need to address public health
concerns, the Commission, after having consulted the MDCG, may, by means of
implementing acts, adopt common specifications (CS) in respect of the general
safety and performance requirements set out in Annex I, the technical
documentation set out in Annexes II and III, the clinical evaluation and post-market
clinical follow-up set out in Annex XIV or the requirements regarding clinical
investigation set out in Annex XV. Those implementing acts shall be adopted in
accordance with the examination procedure referred to in Article 114(3).

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 12 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Recital 12 Change of authorised representative

The detailed arrangements for a change of authorised representative shall be
clearly defined in an agreement between the manufacturer, where practicable the
outgoing authorised representative, and the incoming authorised representative.
That agreement shall address at least the following aspects:
(a) the date of termination of the mandate of the outgoing authorised
representative and date of beginning of the mandate of the incoming authorised
representative;
(b) the date until which the outgoing authorised representative may be indicated in
the information supplied by the manufacturer, including any promotional material;
(c) the transfer of documents, including confidentiality aspects and property rights;
(d) the obligation of the outgoing authorised representative after the end of the
mandate to forward to the manufacturer or incoming authorised representative
any complaints or reports from healthcare professionals, patients or users about
suspected incidents related to a device for which it had been designated as
authorised representative.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 13 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Recital 15 Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person
responsible for regulatory compliance who possesses the requisite expertise in the
field of medical devices. The requisite expertise shall be demonstrated by either of
the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on
completion of a university degree or of a course of study recognised as equivalent
by the Member State concerned, in law, medicine, pharmacy, engineering or
another relevant scientific discipline, and at least one year of professional
experience in regulatory affairs or in quality management systems relating to
medical devices;
(b) four years of professional experience in regulatory affairs or in quality
management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications,
manufacturers of custom-made devices may demonstrate the requisite expertise
referred to in the first subparagraph by having at least two years of professional
experience within a relevant field of manufacturing.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 14 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Recital 19 EU declaration of conformity

1. The EU declaration of conformity shall state that the requirements specified in
this Regulation have been fulfilled in relation to the device that is covered. The
manufacturer shall continuously update the EU declaration of conformity. The EU
declaration of conformity shall, as a minimum, contain the information set out in
Annex IV and shall be translated into an official Union language or languages
required by the Member State(s) in which the device is made available.
2. Where, concerning aspects not covered by this Regulation, devices are subject to
other Union legislation which also requires an EU declaration of conformity by the
manufacturer that fulfilment of the requirements of that legislation has been
demonstrated, a single EU declaration of conformity shall be drawn up in respect of
all Union acts applicable to the device. The declaration shall contain all the
information required for identification of the Union legislation to which the
declaration relates.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for compliance with the requirements of this Regulation and all other
Union legislation applicable to the device.
4. The Commission is empowered to adopt delegated acts in accordance with
Article 115 amending the minimum content of the EU declaration of conformity set
out in Annex IV in the light of technical progress.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 15 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

A Recital 38 (38) The reprocessing and further use of single-use devices should only take place
where permitted by national law and while complying with the requirements laid
down in this Regulation. The reprocessor of a single-use device should be
considered to be the manufacturer of the reprocessed device and should assume
the obligations incumbent on manufacturers under this Regulation. Nevertheless,
Member States should have the possibility of deciding that the obligations relating
to reprocessing and re-use of single-use devices within a health institution or by an
external reprocessor acting on its behalf may differ from the obligations on a
manufacturer described in this Regulation. In principle, such divergence should only
be permitted where reprocessing and reuse of single-use devices within a health
institution or by an external reprocessor are compliant with CS that have been
adopted, or, in the absence of such CS, with relevant harmonised standards and
national provisions. The reprocessing of such devices should ensure an equivalent
level of safety and performance to that of the corresponding initial single-use
device.

28-Nov 09:00 QMS B Quality Manual (inc. PRRC, ISO The organization shall document a quality manual that includes:
Authorized Rep identified, 13485:2016, a) the scope of the quality management system, including details of and
Economic Operators 4.2.2 justification for any exclusion
defined, Virtual or non-application;
Manufacture, b) the documented procedures for the quality management system, or reference to
Communications) them;
c) a description of the interaction between the processes of the quality
management system.
The quality manual shall outline the structure of the documentation used in the
quality management
system.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 16 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B ISO Management commitment

13485:2016, Top management shall provide evidence of its commitment to the development
5.1 and implementation of
the quality management system and maintenance of its effectiveness by:
a) communicating to the organization the importance of meeting customer as well
as applicable
regulatory requirements;
b) establishing the quality policy;
c) ensuring that quality objectives are established;
d) conducting management reviews;
e) ensuring the availability of resources.

B ISO Quality policy

13485:2016, Top management shall ensure that the quality policy:
5.3 a) is applicable to the purpose of the organization;
b) includes a commitment to comply with requirements and to maintain the
effectiveness of the
quality management system;
c) provides a framework for establishing and reviewing quality objectives;
d) is communicated and understood within the organization;
e) is reviewed for continuing suitability.

B ISO Responsibility and authority

13485:2016, Top management shall ensure that responsibilities and authorities are defined,
5.5 documented and
communicated within the organization.
Top management shall document the interrelation of all personnel who manage,
perform and verify work
affecting quality and shall ensure the independence and authority necessary to
perform these tasks.

B ANNEX I.2 GENERAL REQUIREMENTS

2. The requirement in this Annex to reduce risks as far as possible means the
reduction of risks as far as possible without adversely affecting the benefit-risk
ratio.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 17 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B ANNEX IX.2.1 2.1. The manufacturer shall lodge an application for assessment of its quality
management system with a notified body. The application shall include:
— the name of the manufacturer and address of its registered place of business and
any additional manufacturing site covered by the quality management system, and,
if the manufacturer's application is lodged by its authorised representative, the
name of the authorised representative and the address of the authorised
representative's registered place of business,

B General obligations of manufacturers

Article 10

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 18 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B Authorised representative
1. Where the manufacturer of a device is not established in a Member State, the
device may only be placed on the Union market if the manufacturer designates a
sole authorised representative.
2. The designation shall constitute the authorised representative's mandate, it shall
be valid only when accepted in writing by the authorised representative and shall
be effective at least for all devices of the same generic device group.
3. The authorised representative shall perform the tasks specified in the mandate
agreed between it and the manufacturer. The authorised representative shall
provide a copy of the mandate to the competent authority, upon request.
The mandate shall require, and the manufacturer shall enable, the authorised
representative to perform at least the following tasks in relation to the devices that
it covers:
(a) verify that the EU declaration of conformity and technical documentation have
been drawn up and, where applicable, that an appropriate conformity assessment
procedure has been carried out by the manufacturer;
(b) keep available a copy of the technical documentation, the EU declaration of
conformity and, if applicable, a copy of the relevant certificate, including any
Article 11 amendments and supplements, issued in accordance with Article 56, at the disposal
of competent authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Article 31 and verify that
the manufacturer has complied with the registration obligations laid down in
Articles 27 and 29;
(d) in response to a request from a competent authority, provide that competent
authority with all the information and documentation necessary to demonstrate
the conformity of a device, in an official Union language determined by the
Member State concerned;
(e) forward to the manufacturer any request by a competent authority of the
Member State in which the authorised representative has its registered place of
business for samples, or access to a device and verify that the competent authority
receives the samples or is given access to the device;
(f) cooperate with the competent authorities on any preventive or corrective action
taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g) immediately inform the manufacturer about complaints and reports from
healthcare professionals, patients and users about suspected incidents related to a
device for which they have been designated;
(h) terminate the mandate if the manufacturer acts contrary to its obligations under

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 19 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B Change of authorised representative

The detailed arrangements for a change of authorised representative shall be
clearly defined in an agreement between the manufacturer, where practicable the
outgoing authorised representative, and the incoming authorised representative.
That agreement shall address at least the following aspects:
(a) the date of termination of the mandate of the outgoing authorised
representative and date of beginning of the mandate of the incoming authorised
representative;
(b) the date until which the outgoing authorised representative may be indicated in
the information supplied by the manufacturer, including any promotional material;
(c) the transfer of documents, including confidentiality aspects and property rights;
(d) the obligation of the outgoing authorised representative after the end of the
mandate to forward to the manufacturer or incoming authorised representative
Article 12 any complaints or reports from healthcare professionals, patients or users about
suspected incidents related to a device for which it had been designated as
authorised representative.

B General obligations of importers

1. Importers shall place on the Union market only devices that are in conformity
with this Regulation.
2. In order to place a device on the market, importers shall verify that:
(a) the device has been CE marked and that the EU declaration of conformity of the
device has been drawn up;
(b) a manufacturer is identified and that an authorised representative in accordance
with Article 11 has been designated by the manufacturer;
Article 13 (c) the device is labelled in accordance with this Regulation and accompanied by the
required instructions for use;
(d) where applicable, a UDI has been assigned by the manufacturer in accordance
with Article 27.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 20 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B General obligations of distributors

1. When making a device available on the market, distributors shall, in the context
of their activities, act with due care in relation to the requirements applicable.
2. Before making a device available on the market, distributors shall verify that all of
the following requirements are met:
(a) the device has been CE marked and that the EU declaration of conformity of the
device has been drawn up;
(b) the device is accompanied by the information to be supplied by the
Article 14 manufacturer in accordance with Article 10(11);
(c) for imported devices, the importer has complied with the requirements set out
in Article 13(3);
(d) that, where applicable, a UDI has been assigned by the manufacturer.

B Person responsible for regulatory compliance

1. Manufacturers shall have available within their organisation at least one person
responsible for regulatory compliance who possesses the requisite expertise in the
field of medical devices. The requisite expertise shall be demonstrated by either of
the following qualifications:
(a) a diploma, certificate or other evidence of formal qualification, awarded on
completion of a university degree or of a course of study recognised as equivalent
by the Member State concerned, in law, medicine, pharmacy, engineering or
another relevant scientific discipline, and at least one year of professional
experience in regulatory affairs or in quality management systems relating to
medical devices;
(b) four years of professional experience in regulatory affairs or in quality
Article 15 management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications,
manufacturers of custom-made devices may demonstrate the requisite expertise
referred to in the first subparagraph by having at least two years of professional
experience within a relevant field of manufacturing.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 21 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B Cases in which obligations of manufacturers apply to importers, distributors or

other persons
1. A distributor, importer or other natural or legal person shall assume the
obligations incumbent on manufacturers if it does any of the following:
(a) makes available on the market a device under its name, registered trade name
or registered trade mark, except in cases where a distributor or importer enters into
an agreement with a manufacturer whereby the manufacturer is identified as such
on the label and is responsible for meeting the requirements placed on
manufacturers in this Regulation;
Article 16 (b) changes the intended purpose of a device already placed on the market or put
into service;
(c) modifies a device already placed on the market or put into service in such a way
that compliance with the applicable requirements may be affected.

B Unique Device Identification system

1. The Unique Device Identification system (‘UDI system’) described in Part C of
Annex VI shall allow the identification and facilitate the traceability of devices,
other than custom-made and investigational devices, and shall consist of the
following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device,
providing access to the information laid down in Part B of Annex VI;
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production
and if applicable the packaged devices, as specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its packaging;
(c) storage of the UDI by economic operators, health institutions and healthcare
Article 27 professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of
this Article respectively;
(d) establishment of an electronic system for Unique Device Identification (‘UDI
database’) in accordance with Article 28.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 22 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

B (34) It should be ensured that supervision and control of the manufacture of

devices, and the post-market surveillance and vigilance activities concerning them,
are carried out within the manufacturer's organisation by a person responsible for
Recital 34 regulatory compliance who fulfils minimum conditions of qualification.

B (35) For manufacturers who are not established in the Union, the authorised
representative plays a pivotal role in ensuring the compliance of the devices
produced by those manufacturers and in serving as their contact person established
in the Union. Given that pivotal role, for the purposes of enforcement it is
appropriate to make the authorised representative legally liable for defective
devices in the event that a manufacturer established outside the Union has not
complied with its general obligations. The liability of the authorised representative
provided for in this Regulation is without prejudice to the provisions of Directive
85/374/EEC, and accordingly the authorised representative should be jointly and
severally liable with the importer and the manufacturer. The tasks of an authorised
representative should be defined in a written mandate. Considering the role of
authorised representatives, the minimum requirements they should meet should
Recital 35 be clearly defined, including the requirement of having available a person who
fulfils minimum conditions of qualification which should be similar to those for a
manufacturer's person responsible for regulatory compliance.

28-Nov 10:00 Mgmt C Management Review, ISO Quality objectives

Review Quality Objectives, Data 13485:2016, Top management shall ensure that quality objectives, including those needed to
Analysis, Improvement 5.4.1 meet applicable
regulatory requirements and requirements for product, are established at relevant
functions and levels
within the organization. The quality objectives shall be measurable and consistent
with the quality policy.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 23 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C ISO Management review

13485:2016, 5.6.1 General
5.6 The organization shall document procedures for management review. Top
management shall review
the organization’s quality management system at documented planned intervals to
ensure its
continuing suitability, adequacy and effectiveness. The review shall include
assessing opportunities for
improvement and the need for changes to the quality management system,
including the quality policy
and quality objectives.

C ISO Analysis of data

13485:2016, The organization shall document procedures to determine, collect and analyse
8.4 appropriate data
to demonstrate the suitability, adequacy and effectiveness of the quality
management system. The
procedures shall include determination of appropriate methods, including statistical
techniques and
the extent of their use.
The analysis of data shall include data generated as a result of monitoring and
measurement and from
other relevant sources and include, at a minimum, input from:
a) feedback;
b) conformity to product requirements;
c) characteristics and trends of processes and product, including opportunities for
improvement;
d) suppliers;
e) audits;
f) service reports, as appropriate.
If the analysis of data shows that the quality management system is not suitable,
adequate or effective,
the organization shall use this analysis as input for improvement as required in 8.5.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 24 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C ISO Corrective action

13485:2016, The organization shall take action to eliminate the cause of nonconformities in
8.5.2 order to prevent
recurrence. Any necessary corrective actions shall be taken without undue delay.
Corrective actions
shall be proportionate to the effects of the nonconformities encountered.
The organization shall document a procedure to define requirements for:
a) reviewing nonconformities (including complaints);
b) determining the causes of nonconformities;
c) evaluating the need for action to ensure that nonconformities do not recur;
d) planning and documenting action needed and implementing such action,
including, as appropriate,
updating documentation;
e) verifying that the corrective action does not adversely affect the ability to meet
applicable
regulatory requirements or the safety and performance of the medical device;
f) reviewing the effectiveness of corrective action taken.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 25 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C ISO Preventive action

13485:2016, The organization shall determine action to eliminate the causes of potential
8.5.3 nonconformities in order
to prevent their occurrence. Preventive actions shall be proportionate to the effects
of the potential
problems.
The organization shall document a procedure to describe requirements for:
a) determining potential nonconformities and their causes;
b) evaluating the need for action to prevent occurrence of nonconformities;
c) planning and documenting action needed and implementing such action,
including, as appropriate,
updating documentation;
d) verifying that the action does not adversely affect the ability to meet applicable
regulatory
requirements or the safety and performance of the medical device;
e) reviewing the effectiveness of the preventive action taken, as appropriate.

C ANNEX IX
C Article 1 Subject matter and scope
1. This Regulation lays down rules concerning the placing on the market, making
available on the market or putting into service of medical devices for human use
and accessories for such devices in the Union. This Regulation also applies to clinical
investigations concerning such medical devices and accessories conducted in the
Union.
2. This Regulation shall also apply, as from the date of application of common
specifications adopted pursuant to Article 9, to the groups of products without an
intended medical purpose that are listed in Annex XVI, taking into account the state
of the art, and in particular existing harmonised standards for analogous devices
with a medical purpose, based on similar technology. The common specifications
for each of the groups of products listed in Annex XVI shall address, at least,
application of risk management as set out in Annex I for the group of products in
question and, where necessary, clinical evaluation regarding safety.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 26 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C Article 10 General obligations of manufacturers

C Article 81 Implementing acts

The Commission may, by means of implementing acts, establish the detailed
arrangements and procedural aspects necessary for the implementation of this
Chapter as regards the following:
(a) harmonised electronic forms for the application for clinical investigations and
their assessment as referred to in Articles 70 and 78, taking into account specific
categories or groups of devices;
(b) the functioning of the electronic system referred to in Article 73;
(c) harmonised electronic forms for the notification of PMCF investigations as
referred to in Article 74(1), and of substantial modifications as referred to in Article
75;
(d) the exchange of information between Member States as referred to in Article
76;
(e) harmonised electronic forms for the reporting of serious adverse events and
device deficiencies as referred to in Article 80;
(f) the timelines for the reporting of serious adverse events and device deficiencies,
taking into account the severity of the event to be reported as referred to in Article
80;
(g) uniform application of the requirements regarding the clinical evidence or data
needed to demonstrate compliance with the general safety and performance
requirements set out in Annex I.
The implementing acts referred to in the first paragraph shall be adopted in
accordance with the examination procedure referred to in Article 114(3).

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 27 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C Article 87 Reporting of serious incidents and field safety corrective actions

1. Manufacturers of devices made available on the Union market, other than
investigational devices, shall report, to the relevant competent authorities, in
accordance with Articles 92(5) and (7), the following:
(a) any serious incident involving devices made available on the Union market,
except expected side-effects which are clearly documented in the product
information and quantified in the technical documentation and are subject to trend
reporting pursuant to Article 88;
(b) any field safety corrective action in respect of devices made available on the
Union market, including any field safety corrective action undertaken in a third
country in relation to a device which is also legally made available on the Union
market, if the reason for the field safety corrective action is not limited to the
device made available in the third country.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 28 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C Article 88 Trend reporting

1. Manufacturers shall report, by means of the electronic system referred to in
Article 92, any statistically significant increase in the frequency or severity of
incidents that are not serious incidents or that are expected undesirable side-
effects that could have a significant impact on the benefit-risk analysis ►C2
referred to in Sections 1 and 8 of Annex I and which ◄ have led or may lead to risks
to the health or safety of patients, users or other persons that are unacceptable
when weighed against the intended benefits. The significant increase shall be
established in comparison to the foreseeable frequency or severity of such
incidents in respect of the device, or category or group of devices, in question
during a specific period as specified in the technical documentation and product
information.
The manufacturer shall specify how to manage the incidents referred to in the first
subparagraph and the methodology used for determining any statistically significant
increase in the frequency or severity of such incidents, as well as the observation
period, in the post-market surveillance plan referred to in Article 84.
2. The competent authorities may conduct their own assessments on the trend
reports referred to in paragraph 1 and require the manufacturer to adopt
appropriate measures in accordance with this Regulation in order to ensure the
protection of public health and patient safety. Each competent authority shall
inform the Commission, the other competent authorities and the notified body that
issued the certificate, of the results of such assessment and of the adoption of such
measures.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 29 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

C Article 89 Analysis of serious incidents and field safety corrective actions

1. Following the reporting of a serious incident pursuant to Article 87(1), the
manufacturer shall, without delay, perform the necessary investigations in relation
to the serious incident and the devices concerned. This shall include a risk
assessment of the incident and field safety corrective action taking into account
criteria as referred to in paragraph 3 of this Article as appropriate.
The manufacturer shall co-operate with the competent authorities and where
relevant with the notified body concerned during the investigations referred to in
the first subparagraph and shall not perform any investigation which involves
altering the device or a sample of the batch concerned in a way which may affect
any subsequent evaluation of the causes of the incident, prior to informing the
competent authorities of such action.
2. Member States shall take the necessary steps to ensure that any information
regarding a serious incident that has occurred within their territory, or a field safety
corrective action that has been or is to be undertaken within their territory, and
that is brought to their knowledge in accordance with Article 87 is evaluated
centrally at national level by their competent authority, if possible together with
the manufacturer, and, where relevant, the notified body concerned.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 30 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 11:00 Int D Internal Audit ISO Internal audit

Audit 13485:2016, The organization shall conduct internal audits at planned intervals to determine
8.2.4 whether the quality management system:
a) conforms to planned and documented arrangements, requirements of this
International Standard, quality management system requirements established by
the organization, and applicable
regulatory requirements;

b) is effectively implemented and maintained.

The organization shall document a procedure to describe the responsibilities and

requirements for planning and conducting audits and recording and reporting audit
results.

An audit program shall be planned, taking into consideration the status and
importance of the processes and area to be audited, as well as the results of
previous audits. The audit criteria, scope, interval and
methods shall be defined and recorded (see 4.2.5). The selection of auditors and
conduct of audits shall ensure objectivity and impartiality of the audit process.
Auditors shall not audit their own work.

Records of the audits and their results, including identification of the processes and
areas audited and the conclusions, shall be maintained (see 4.2.5).

The management responsible for the area being audited shall ensure that any
necessary corrections and corrective actions are taken without undue delay to
eliminate detected nonconformities and their
causes. Follow-up activities shall include the verification of the actions taken and
the reporting of verification results.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 31 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

D ANNEX IX.1 QUALITY MANAGEMENT SYSTEM

1. The manufacturer shall establish, document and implement a quality
management system as described in Article 10(9) and maintain its effectiveness
throughout the life cycle of the devices concerned. The manufacturer shall ensure
the application of the quality management system as specified in Section 2 and shall
be subject to audit, as laid down in Sections 2.3 and 2.4, and to surveillance as
specified in Section 3.
2. Quality management system assessment
2.1. The manufacturer shall lodge an application for assessment of its quality
management system with a notified body. The application shall include:
— the name of the manufacturer and address of its registered place of business and
any additional manufacturing site covered by the quality management system, and,
if the manufacturer's application is lodged by its authorised representative, the
name of the authorised representative and the address of the authorised
representative's registered place of business,
— all relevant information on the device or group of devices covered by the quality
management system,
— a written declaration that no application has been lodged with any other notified
body for the same device-related quality management system, or information
about any previous application for the same device-related quality management
system,
— a draft of an EU declaration of conformity in accordance with Article 19 and
Annex IV for the device model covered by the conformity assessment procedure,
— the documentation on the manufacturer's quality management system,
— a documented description of the procedures in place to fulfil the obligations
arising from the quality management system and required under this Regulation
and the undertaking by the manufacturer in question to apply those procedures,
— a description of the procedures in place to ensure that the quality management
system remains adequate and effective, and the undertaking by the manufacturer
to apply those procedures,
— the documentation on the manufacturer's post-market surveillance system and,
where applicable, on the PMCF plan, and the procedures put in place to ensure
compliance with the obligations resulting from the provisions on vigilance set out in
Articles 87 to 92,
— a description of the procedures in place to keep up to date the post-market
surveillance system, and, where applicable, the PMCF plan, and the procedures
ensuring compliance with the obligations resulting from the provisions on vigilance
D Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 32 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 12:30 CAPA E Corrective & Preventive ISO Control of nonconforming product
Action 13485:2016, 8.3.1 General
8.3 The organization shall ensure that product which does not conform to product
requirements is
identified and controlled to prevent its unintended use or delivery. The organization
shall document
a procedure to define the controls and related responsibilities and authorities for
the identification,
documentation, segregation, evaluation and disposition of nonconforming product.
The evaluation of nonconformity shall include a determination of the need for an
investigation and
notification of any external party responsible for the nonconformity.
Records of the nature of the nonconformities and any subsequent action taken,
including the evaluation,
any investigation and the rationale for decisions shall be maintained (see 4.2.5)

E ISO Improvement
13485:2016, 8.5.1 General
8.5 The organization shall identify and implement any changes necessary to ensure and
maintain the
continued suitability, adequacy and effectiveness of the quality management
system as well as medical
device safety and performance through the use of the quality policy, quality
objectives, audit results, postmarket
surveillance, analysis of data, corrective actions, preventive actions and
management review.

E Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 33 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 13:30 PMS F PMS Procedures ISO Monitoring and measurement

13485:2016, 8.2.1 Feedback
8.2.1 As one of the measurements of the effectiveness of the quality management
system, the organization
shall gather and monitor information relating to whether the organization has met
customer
requirements. The methods for obtaining and using this information shall be
documented.
The organization shall document procedures for the feedback process. This
feedback process shall
include provisions to gather data from production as well as post-production
activities.
The information gathered in the feedback process shall serve as potential input into
risk management
for monitoring and maintaining the product requirements as well as the product
realization or
improvement processes.
If applicable regulatory requirements require the organization to gain specific
experience from postproduction
activities, the review of this experience shall form part of the feedback process.

F ANNEX III.1 TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the
manufacturer in accordance with Articles 83 to 86 shall be presented in a clear,
organised, readily searchable and unambiguous manner and shall include in
particular the elements described in this Annex.

1. The post-market surveillance plan drawn up in accordance with Article 84.

F ANNEX IX.2.1 QUALITY MANAGEMENT SYSTEM

F Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 34 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

F Article 83 Post-market surveillance system of the manufacturer

1. For each device, manufacturers shall plan, establish, document, implement,
maintain and update a post-market surveillance system in a manner that is
proportionate to the risk class and appropriate for the type of device. That system
shall be an integral part of the manufacturer's quality management system referred
to in Article 10(9).
2. The post-market surveillance system shall be suited to actively and systematically
gathering, recording and analysing relevant data on the quality, performance and
safety of a device throughout its entire lifetime, and to drawing the necessary
conclusions and to determining, implementing and monitoring any preventive and
corrective actions.
3. Data gathered by the manufacturer's post-market surveillance system shall in
particular be used:
(a) to update the benefit-risk determination and to improve the risk management
as referred to in Chapter I of Annex I;
(b) to update the design and manufacturing information, the instructions for use
and the labelling;
(c) to update the clinical evaluation;
(d) to update the summary of safety and clinical performance referred to in Article
32;
(e) for the identification of needs for preventive, corrective or field safety corrective
action;
(f) for the identification of options to improve the usability, performance and safety
of the device;
(g) when relevant, to contribute to the post-market surveillance of other devices;
and
(h) to detect and report trends in accordance with Article 88.
The technical documentation shall be updated accordingly.
4. If, in the course of the post-market surveillance, a need for preventive or
corrective action or both is identified, the manufacturer shall implement the
appropriate measures and inform the competent authorities concerned and, where
applicable, the notified body. Where a serious incident is identified or a field safety
corrective action is implemented, it shall be reported in accordance with Article 87.

F Article 84 Post-market surveillance plan

The post-market surveillance system referred to in Article 83 shall be based on a
post-market surveillance plan, the requirements for which are set out in ►C2
Section 1 of Annex III. ◄ For devices other than custom-made devices, the post-
market surveillance plan shall be part of the technical documentation specified in
Annex II.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 35 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

F Article 85 Post-market surveillance report

Manufacturers of class I devices shall prepare a post-market surveillance report
summarising the results and conclusions of the analyses of the post-market
surveillance data gathered as a result of the post-market surveillance plan referred
to in Article 84 together with a rationale and description of any preventive and
corrective actions taken. The report shall be updated when necessary and made
available to the competent authority upon request.

F Article 86 Periodic safety update report

1. Manufacturers of class IIa, class IIb and class III devices shall prepare a periodic
safety update report (‘PSUR’) for each device and where relevant for each category
or group of devices summarising the results and conclusions of the analyses of the
post-market surveillance data gathered as a result of the post-market surveillance
plan referred to in Article 84 together with a rationale and description of any
preventive and corrective actions taken. Throughout the lifetime of the device
concerned, that PSUR shall set out:
(a) the conclusions of the benefit-risk determination;
(b) the main findings of the PMCF; and
(c) the volume of sales of the device and an estimate evaluation of the size and
other characteristics of the population using the device and, where practicable, the
usage frequency of the device.
Manufacturers of class IIb and class III devices shall update the PSUR at least
annually. That PSUR shall, except in the case of custom-made devices, be part of
the technical documentation as specified in Annexes II and III.
Manufacturers of class IIa devices shall update the PSUR when necessary and at
least every two years. That PSUR shall, except in the case of custom-made devices,
be part of the technical documentation as specified in Annexes II and III.
For custom-made devices, the PSUR shall be part of the documentation referred to
in Section 2 of Annex XIII.
2. For class III devices or implantable devices, manufacturers shall submit PSURs by
means of the electronic system referred to in Article 92 to the notified body
involved in the conformity assessment in accordance with Article 52. The notified
body shall review the report and add its evaluation to that electronic system with
details of any action taken. Such PSURs and the evaluation by the notified body
shall be made available to competent authorities through that electronic system.
3. For devices other than those referred to in paragraph 2, manufacturers shall
make PSURs available to the notified body involved in the conformity assessment
and, upon request, to competent authorities.

F Article 88 Trend reporting

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 36 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

F Recital 48 (48) For implantable devices and for class III devices, manufacturers should
summarise the main safety and performance aspects of the device and the
outcome of the clinical evaluation in a document that should be publicly available.

F Recital 74 (74) Manufacturers should play an active role during the post-market phase by
systematically and actively gathering information from post-market experience with
their devices in order to update their technical documentation and cooperate with
the national competent authorities in charge of vigilance and market surveillance
activities. To this end, manufacturers should establish a comprehensive post-
market surveillance system, set up under their quality management system and
based on a post-market surveillance plan. Relevant data and information gathered
through post-market surveillance, as well as lessons learned from any implemented
preventive and/or corrective actions, should be used to update any relevant part of
technical documentation, such as those relating to risk assessment and clinical
evaluation, and should also serve the purpose of transparency.

28-Nov 13:30 PMS G Device PMS Plan, Report ISO Monitoring and measurement
13485:2016,
8.2.1

G Article 10 General obligations of manufacturers

G Article 83
G Article 84
G Article 85
G Article 86
G Article 88 Trend reporting
28-Nov 13:30 PMS H PMS Input for Risk Mgmt ISO Monitoring and measurement
& Clinical Eval 13485:2016,
8.2.1

H Article 10 General obligations of manufacturers

H Article 83
H Article 84
H Article 85
H Article 86

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 37 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

H Article 88
H Recital 74
28-Nov 13:30 PMS I PSUR ISO Monitoring and measurement
13485:2016,
8.2.1

I Article 10 General obligations of manufacturers

I Article 83
I Article 84
I Article 85
I Article 86
I Article 88 Trend reporting
28-Nov 13:30 PMS J PMCF, SSCP ISO Monitoring and measurement
13485:2016,
8.2.1

J ANNEX IX.2.1 QUALITY MANAGEMENT SYSTEM

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 38 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

J ANNEX IX.2.2 Implementation of the quality management system shall ensure compliance with
this Regulation. All the elements, requirements and provisions adopted by the
manufacturer for its quality management system shall be documented in a
systematic and orderly manner in the form of a quality manual and written policies
and procedures such as quality programmes, quality plans and quality records.
Moreover, the documentation to be submitted for the assessment of the quality
management system shall include an adequate description of, in particular:
(a) the manufacturer's quality objectives;
(b) the organisation of the business and in particular:
— the organisational structures with the assignment of staff responsibilities in
relation to critical procedures, the responsibilities of the managerial staff and their
organisational authority,
— the methods of monitoring whether the operation of the quality management
system is efficient and in particular the ability of that system to achieve the desired
design and device quality, including control of devices which fail to conform,
— where the design, manufacture and/or final verification and testing of the
devices, or parts of any of those processes, is carried out by another party, the
methods of monitoring the efficient operation of the quality management system
and in particular the type and extent of control applied to the other party, and
— where the manufacturer does not have a registered place of business in a
Member State, the draft mandate for the designation of an authorised
representative and a letter of intention from the authorised representative to
accept the mandate;
(c) the procedures and techniques for monitoring, verifying, validating and
controlling the design of the devices and the corresponding documentation as well
as the data and records arising from those procedures and techniques. Those
procedures and techniques shall specifically cover:
— the strategy for regulatory compliance, including processes for identification of
relevant legal requirements, qualification, classification, handling of equivalence,
choice of and compliance with conformity assessment procedures,
— identification of applicable general safety and performance requirements and
solutions to fulfil those requirements, taking applicable CS and, where opted for,
harmonised standards or other adequate solutions into account,
— risk management as referred to in Section 3 of Annex I,
— the clinical evaluation, pursuant to Article 61 and Annex XIV, including post-
market clinical follow-up,
J Article 10 General obligations of manufacturers

J Article 32 Summary of safety and clinical performance

1. For implantable devices and for class III devices, other than custom-made or
investigational devices, the manufacturer shall draw up a summary of safety and
clinical performance.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 39 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

J Article 61 Clinical evaluation

1. Confirmation of conformity with relevant general safety and performance
requirements set out in Annex I under the normal conditions of the intended use of
the device, and the evaluation of the undesirable side-effects and of the
acceptability of the benefit-risk- ratio referred to in Sections 1 and 8 of Annex I,
shall be based on clinical data providing sufficient clinical evidence, including where
applicable relevant data as referred to in Annex III.
The manufacturer shall specify and justify the level of clinical evidence necessary to
demonstrate conformity with the relevant general safety and performance
requirements. That level of clinical evidence shall be appropriate in view of the
characteristics of the device and its intended purpose.
To that end, manufacturers shall plan, conduct and document a clinical evaluation
in accordance with this Article and Part A of Annex XIV.
2. For all class III devices and for the class IIb devices referred to in point (b) of
Article 54(1), the manufacturer may, prior to its clinical evaluation and/or
investigation, consult an expert panel as referred to in Article 106, with the aim of
reviewing the manufacturer's intended clinical development strategy and proposals
for clinical investigation. The manufacturer shall give due consideration to the views
expressed by the expert panel. Such consideration shall be documented in the
clinical evaluation report referred to in paragraph 12 of this Article.
The manufacturer may not invoke any rights to the views expressed by the expert
panel with regard to any future conformity assessment procedure.
3. A clinical evaluation shall follow a defined and methodologically sound procedure
based on the following:
(a) a critical evaluation of the relevant scientific literature currently available
relating to the safety, performance, design characteristics and intended purpose of
the device, where the following conditions are satisfied:
— it is demonstrated that the device subject to clinical evaluation for the intended
purpose is equivalent to the device to which the data relate, in accordance with
Section 3 of Annex XIV, and
— the data adequately demonstrate compliance with the relevant general safety
and performance requirements;
(b) a critical evaluation of the results of all available clinical investigations, taking
duly into consideration whether the investigations were performed under Articles
62 to 80, any acts adopted pursuant to Article 81, and Annex XV; and
(c) a consideration of currently available alternative treatment options for that
purpose, if any.
J Recital 48

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 40 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 14:30 K Complaints ISO Complaint handling

Complaint 13485:2016, The organization shall document procedures for timely complaint handling in
Handling 8.2.2 accordance with
applicable regulatory requirements.
These procedures shall include at a minimum requirements and responsibilities for:
a) receiving and recording information;
b) evaluating information to determine if the feedback constitutes a complaint;
c) investigating complaints;
d) determining the need to report the information to the appropriate regulatory
authorities;
e) handling of complaint-related product;
f) determining the need to initiate corrections or corrective actions.
If any complaint is not investigated, justification shall be documented. Any
correction or corrective
action resulting from the complaint handling process shall be documented.
If an investigation determines activities outside the organization contributed to the
complaint, relevant
information shall be exchanged between the organization and the external party
involved.

K ISO Reporting to regulatory authorities

13485:2016, If applicable regulatory requirements require notification of complaints that meet
8.2.3 specified reporting
criteria of adverse events or issuance of advisory notices, the organization shall
document procedures
for providing notification to the appropriate regulatory authorities.

K ANNEX IX.2.1 QUALITY MANAGEMENT SYSTEM

K Article 10 General obligations of manufacturers

K Article 81
K Article 87
K Article 88
K Article 89

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 41 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 14:30 L Vigilance Reporting ISO

Complaint 13485:2016,
Handling 8.2.2

L ISO
13485:2016,
8.2.3

L ISO Actions in response to nonconforming product detected after delivery

13485:2016, When nonconforming product is detected after delivery or use has started, the
8.3.3 organization shall take
action appropriate to the effects, or potential effects, of the nonconformity.
Records of actions taken
shall be maintained (see 4.2.5).
The organization shall document procedures for issuing advisory notices in
accordance with applicable
regulatory requirements. These procedures shall be capable of being put into effect
at any time. Records
of actions relating to the issuance of advisory notices shall be maintained (see
4.2.5).

L ANNEX IX.2.1 QUALITY MANAGEMENT SYSTEM

L Article 10 General obligations of manufacturers

L Article 81
L Article 87
L Article 88
L Article 89

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 42 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

28-Nov 15:30 M Control of Documents & ISO Control of documents

Control of Records, Retention & 13485:2016, Documents required by the quality management system shall be controlled.
Documents Administrative Provision 4.2.4 Records are a special type
of document and shall be controlled according to the requirements given in 4.2.5.
A documented procedure shall define the controls needed to:
a) review and approve documents for adequacy prior to issue;
b) review, update as necessary and re-approve documents;
c) ensure that the current revision status of and changes to documents are
identified;
d) ensure that relevant versions of applicable documents are available at points of
use;
e) ensure that documents remain legible and readily identifiable;
f) ensure that documents of external origin, determined by the organization to be
necessary for the
planning and operation of the quality management system, are identified and their
distribution
controlled;
g) prevent deterioration or loss of documents;
h) prevent the unintended use of obsolete documents and apply suitable
identification to them.

M ISO Monitoring and measurement of processes The organization shall apply suitable
13485:2016, methods for monitoring and, as appropriate, measurement of the quality
4.2.5 management system processes. These methods shall demonstrate the ability of the
processes to achieve planned results. When planned results are not achieved,
correction and corrective action shall be taken, as appropriate.

M ANNEX IX
M Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 43 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 08:30 Design N Design & Development ISO Design and development
& (inc. Regulatory Strategy, 13485:2016, 7.3.1 General
Developmen Software/Cybersecurity, 7.3 The organization shall document procedures for design and development.
t Labelling/CE Mark, UDI, 7.3.2 Design and development planning
Translation, Website, The organization shall plan and control the design and development of product. As
GSPR/State of the Art, appropriate, design
Custom / Custom and development planning documents shall be maintained and updated as the
Implantable Devices design and development
progresses.
During design and development planning, the organization shall document:
a) the design and development stages;
b) the review(s) needed at each design and development stage;
c) the verification, validation, and design transfer activities that are appropriate at
each design and
development stage;
d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design
and
development inputs;
f) the resources needed, including necessary competence of personnel.

N ANNEX I.10.4.5 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 44 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N ANNEX I.14.2 Devices shall be designed and manufactured in such a way as to remove or reduce
as far as possible:
(a) the risk of injury, in connection with their physical features, including the
volume/pressure ratio, dimensional and where appropriate ergonomic features;
(b) risks connected with reasonably foreseeable external influences or
environmental conditions, such as magnetic fields, external electrical and
electromagnetic effects, electrostatic discharge, radiation associated with
diagnostic or therapeutic procedures, pressure, humidity, temperature, variations in
pressure and acceleration or radio signal interferences;
(c) the risks associated with the use of the device when it comes into contact with
materials, liquids, and substances, including gases, to which it is exposed during
normal conditions of use;
(d) the risks associated with the possible negative interaction between software and
the IT environment within which it operates and interacts;
(e) the risks of accidental ingress of substances into the device;
(f) the risks of reciprocal interference with other devices normally used in the
investigations or for the treatment given; and
(g) risks arising where maintenance or calibration are not possible (as with
implants), from ageing of materials used or loss of accuracy of any measuring or
control mechanism.

N ANNEX I.17 Electronic programmable systems — devices that incorporate electronic NA

programmable systems and software that are devices in themselves
N ANNEX I.23 Label and instructions for use

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 45 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N ANNEX I.23.1 General requirements regarding the information supplied by the manufacturer
Each device shall be accompanied by the information needed to identify the device
and its manufacturer, and by any safety and performance information relevant to
the user, or any other person, as appropriate. Such information may appear on the
device itself, on the packaging or in the instructions for use, and shall, if the
manufacturer has a website, be made available and kept up to date on the website,
taking into account the following:
(a) The medium, format, content, legibility, and location of the label and
instructions for use shall be appropriate to the particular device, its intended
purpose and the technical knowledge, experience, education or training of the
intended user(s). In particular, instructions for use shall be written in terms readily
understood by the intended user and, where appropriate, supplemented with
drawings and diagrams.
(b) The information required on the label shall be provided on the device itself. If
this is not practicable or appropriate, some or all of the information may appear on
the packaging for each unit, and/or on the packaging of multiple devices.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 46 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N ANNEX I.23.4 Information in the instructions for use

The instructions for use shall contain all of the following particulars:
(a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section
23.2;
(b) the device's intended purpose with a clear specification of indications, contra-
indications, the patient target group or groups, and of the intended users, as
appropriate;
(c) where applicable, a specification of the clinical benefits to be expected.
(d) where applicable, links to the summary of safety and clinical performance
referred to in Article 32;
(e) the performance characteristics of the device;
(f) where applicable, information allowing the healthcare professional to verify if
the device is suitable and select the corresponding software and accessories;
(g) any residual risks, contra-indications and any undesirable side-effects, including
information to be conveyed to the patient in this regard;
(h) specifications the user requires to use the device appropriately, e.g. if the device
has a measuring function, the degree of accuracy claimed for it;
(i) details of any preparatory treatment or handling of the device before it is ready
for use or during its use, such as sterilisation, final assembly, calibration, etc.,
including the levels of disinfection required to ensure patient safety and all
available methods for achieving those levels of disinfection;
(j) any requirements for special facilities, or special training, or particular
qualifications of the device user and/or other persons;

N ANNEX II.2 INFORMATION TO BE SUPPLIED BY THE MANUFACTURER

A complete set of:
— the label or labels on the device and on its packaging, such as single unit
packaging, sales packaging, transport packaging in case of specific management
conditions, in the languages accepted in the Member States where the device is
envisaged to be sold; and
— the instructions for use in the languages accepted in the Member States where
the device is envisaged to be sold.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 47 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N ANNEX V CE MARKING OF CONFORMITY

1. The CE marking shall consist of the initials ‘CE’ taking the following form:

N Annex CORRELATION TABLE between 90/385/EEC and 93/42/EEC and MDR 2017/745
XV.II.3.1.5
N Article 1
N Article 10 General obligations of manufacturers

N Article 18 Implant card and information to be supplied to the patient with an implanted
device
1. The manufacturer of an implantable device shall provide together with the
device the following:
(a) information allowing the identification of the device, including the device name,
serial number, lot number, the UDI, the device model, as well as the name, address
and the website of the manufacturer;
(b) any warnings, precautions or measures to be taken by the patient or a
healthcare professional with regard to reciprocal interference with reasonably
foreseeable external influences, medical examinations or environmental conditions;
(c) any information about the expected lifetime of the device and any necessary
follow-up;
(d) any other information to ensure safe use of the device by the patient, including
the information in point (u) of Section 23.4 of Annex I.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 48 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N Article 19 EU declaration of conformity

1. The EU declaration of conformity shall state that the requirements specified in
this Regulation have been fulfilled in relation to the device that is covered. The
manufacturer shall continuously update the EU declaration of conformity. The EU
declaration of conformity shall, as a minimum, contain the information set out in
Annex IV and shall be translated into an official Union language or languages
required by the Member State(s) in which the device is made available.
2. Where, concerning aspects not covered by this Regulation, devices are subject to
other Union legislation which also requires an EU declaration of conformity by the
manufacturer that fulfilment of the requirements of that legislation has been
demonstrated, a single EU declaration of conformity shall be drawn up in respect of
all Union acts applicable to the device. The declaration shall contain all the
information required for identification of the Union legislation to which the
declaration relates.
3. By drawing up the EU declaration of conformity, the manufacturer shall assume
responsibility for compliance with the requirements of this Regulation and all other
Union legislation applicable to the device.
4. The Commission is empowered to adopt delegated acts in accordance with
Article 115 amending the minimum content of the EU declaration of conformity set
out in Annex IV in the light of technical progress.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 49 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

N Article 20 CE marking of conformity

1. Devices, other than custom-made or investigational devices, considered to be in
conformity with the requirements of this Regulation shall bear the CE marking of
conformity, as presented in Annex V.
2. The CE marking shall be subject to the general principles set out in Article 30 of
Regulation (EC) No 765/2008.
3. The CE marking shall be affixed visibly, legibly and indelibly to the device or its
sterile packaging. Where such affixing is not possible or not warranted on account
of the nature of the device, the CE marking shall be affixed to the packaging. The CE
marking shall also appear in any instructions for use and on any sales packaging.
4. The CE marking shall be affixed before the device is placed on the market. It may
be followed by a pictogram or any other mark indicating a special risk or use.
5. Where applicable, the CE marking shall be followed by the identification number
of the notified body responsible for the conformity assessment procedures set out
in Article 52. The identification number shall also be indicated in any promotional
material which mentions that a device fulfils the requirements for CE marking.
6. Where devices are subject to other Union legislation which also provides for the
affixing of the CE marking, the CE marking shall indicate that the devices also fulfil
the requirements of that other legislation.

N Article 27
N Article 89
N Recital 39 (39) Patients who are implanted with a device should be given clear and easily
accessible essential information allowing the implanted device to be identified and
other relevant information about the device, including any necessary health risk
warnings or precautions to be taken, for example indications as to whether or not it
is compatible with certain diagnostic devices or with scanners used for security
controls.

N Recital 48

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 50 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 08:30 Design O Design & Development ISO The organization shall manage these quality management system processes in
& Changes (inc. 13485:2016, accordance with
Developmen Determination & 4.1.4 the requirements of this International Standard and applicable regulatory
t Notification of Substantial requirements. Changes to be
Change made to these processes shall be:
a) evaluated for their impact on the quality management system;
b) evaluated for their impact on the medical devices produced under this quality
management system;
c) controlled in accordance with the requirements of this International Standard
and applicable
regulatory requirements.

O ISO Design and development planning

13485:2016, The organization shall plan and control the design and development of product. As
7.2.3 appropriate, design
and development planning documents shall be maintained and updated as the
design and development
progresses.
During design and development planning, the organization shall document:
a) the design and development stages;
b) the review(s) needed at each design and development stage;
c) the verification, validation, and design transfer activities that are appropriate at
each design and
development stage;
d) the responsibilities and authorities for design and development;
e) the methods to ensure traceability of design and development outputs to design
and
development inputs;
f) the resources needed, including necessary competence of personnel.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 51 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

O ISO Control of design and development changes

13485:2016, The organization shall document procedures to control design and development
7.3.9 changes. The
organization shall determine the significance of the change to function,
performance, usability, safety
and applicable regulatory requirements for the medical device and its intended use.
Design and development changes shall be identified. Before implementation, the
changes shall be:
a) reviewed;
b) verified;
c) validated, as appropriate;
d) approved.
The review of design and development changes shall include evaluation of the
effect of the changes on
constituent parts and product in process or already delivered, inputs or outputs of
risk management
and product realization processes.

O ANNEX IX.2.4 The manufacturer in question shall inform the notified body which approved the
quality management system of any plan for substantial changes to the quality
management system, or the device-range covered. The notified body shall assess
the changes proposed, determine the need for additional audits and verify whether
after those changes the quality management system still meets the requirements
referred to in Section 2.2. It shall notify the manufacturer of its decision which shall
contain the conclusions of the assessment, and where applicable, conclusions of
additional audits. The approval of any substantial change to the quality
management system or the device-range covered shall take the form of a
supplement to the EU quality management system certificate.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 52 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

O ANNEX VII Product verification

4.5.3 Assessment of the technical documentation
For assessment of the technical documentation conducted in accordance with
Chapter II of Annex IX, notified bodies shall have sufficient expertise, facilities and
documented procedures for:
— the allocation of appropriately qualified and authorised personnel for the
examination of individual aspects such as use of the device, biocompatibility,
clinical evaluation, risk management, and sterilisation, and
— the assessment of conformity of the design with this Regulation, and for taking
account of Sections 4.5.4. to 4.5.6. That assessment shall include examination of
the implementation by manufacturers of incoming, in-process and final checks and
the results thereof. If further tests or other evidence is required for the assessment
of conformity with the requirements of this Regulation, the notified body in
question shall carry out adequate physical or laboratory tests in relation to the
device or request the manufacturer to carry out such tests.
Type-examinations
The notified body shall have documented procedures, sufficient expertise and
facilities for the type-examination of devices in accordance with Annex X including
the capacity to:
— examine and assess the technical documentation taking account of Sections
4.5.4. to 4.5.6., and verify that the type has been manufactured in conformity with
that documentation;
— establish a test plan identifying all relevant and critical parameters which need to
be tested by the notified body or under its responsibility;
— document its rationale for the selection of those parameters;
— carry out the appropriate examinations and tests in order to verify that the
solutions adopted by the manufacturer meet the general safety and performance
requirements set out in Annex I. Such examinations and tests shall include all tests
necessary to verify that the manufacturer has in fact applied the relevant standards
it has opted to use;

O Article 10

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 53 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 08:30 Design P Clinical Evaluation (inc. ISO Design and development validation
& PMCF, SSCP, PMS input) 13485:2016, Design and development validation shall be performed in accordance with planned
Developmen 7.3.7 and documented
t arrangements to ensure that the resulting product is capable of meeting the
requirements for the
specified application or intended use.
The organization shall document validation plans that include methods, acceptance
criteria and, as
appropriate, statistical techniques with rationale for sample size.
Design validation shall be conducted on representative product. Representative
product includes
initial production units, batches or their equivalents. The rationale for the choice of
product used for
validation shall be recorded (see 4.2.5).
As part of design and development validation, the organization shall perform
clinical evaluations or
performance evaluations of the medical device in accordance with applicable
regulatory requirements.
A medical device used for clinical evaluation or performance evaluation is not
considered to be released
for use to the customer.
If the intended use requires that the medical device be connected to, or have an
interface with, other
medical device(s), validation shall include confirmation that the requirements for
the specified
application or intended use have been met when so connected or interfaced.
Validation shall be completed prior to release for use of the product to the
customer.

P ANNEX IX.2.1
P ANNEX IX.2.2
P Annex XIV
P Article 10 General obligations of manufacturers

P Article 32 Summary of safety and clinical performance

P Article 61 Clinical evaluation
P Recital 48

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 54 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

P Recital 51 (51) Notified bodies' assessments of manufacturers' technical documentation, in

particular documentation on clinical evaluation, should be critically evaluated by
the authority responsible for notified bodies. That evaluation should be part of the
risk-based approach to the oversight and monitoring activities of notified bodies
and should be based on sampling of the relevant documentation.

P Recital 64 (64) The rules on clinical investigations should be in line with well-established
international guidance in this field, such as the international standard ISO
14155:2011 on good clinical practice for clinical investigations of medical devices
for human subjects, so as to make it easier for the results of clinical investigations
conducted in the Union to be accepted as documentation outside the Union and to
make it easier for the results of clinical investigations conducted outside the Union
in accordance with international guidelines to be accepted within the Union. In
addition, the rules should be in line with the most recent version of the World
Medical Association Declaration of Helsinki on Ethical Principles for Medical
Research Involving Human Subjects.

29-Nov 08:30 Design Q Clinical Investigation ISO

& (Process, sponsor, consent, 13485:2016,
Developmen application, adverse 7.3.7
t events) Article 62

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 55 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

Q Article 63 Informed consent

1. Informed consent shall be written, dated and signed by the person performing
the interview referred to in point (c) of paragraph 2, and by the subject or, where
the subject is not able to give informed consent, his or her legally designated
representative after having been duly informed in accordance with paragraph 2.
Where the subject is unable to write, consent may be given and recorded through
appropriate alternative means in the presence of at least one impartial witness. In
that case, the witness shall sign and date the informed consent document. The
subject or, where the subject is not able to give informed consent, his or her legally
designated representative shall be provided with a copy of the document or the
record, as appropriate, by which informed consent has been given. The informed
consent shall be documented. Adequate time shall be given for the subject or his or
her legally designated representative to consider his or her decision to participate in
the clinical investigation.

Q Article 69 Damage compensation

1. Member States shall ensure that systems for compensation for any damage
suffered by a subject resulting from participation in a clinical investigation
conducted on their territory are in place in the form of insurance, a guarantee, or a
similar arrangement that is equivalent as regards its purpose and which is
appropriate to the nature and the extent of the risk.
2. The sponsor and the investigator shall make use of the system referred to in
paragraph 1 in the form appropriate for the Member State in which the clinical
investigation is conducted.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 56 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

Q Article 70 Application for clinical investigations

1. The sponsor of a clinical investigation shall submit an application to the Member
State(s) in which the clinical investigation is to be conducted (referred to for the
purposes of this Article as ‘Member State concerned’) accompanied by the
documentation referred to in Chapter II of Annex XV.
The application shall be submitted by means of the electronic system referred to in
Article 73, which shall generate a Union-wide unique single identification number
for the clinical investigation, which shall be used for all relevant communication in
relation to that clinical investigation. Within 10 days of it receiving the application,
the Member State concerned shall notify the sponsor as to whether the clinical
investigation falls within the scope of this Regulation and as to whether the
application dossier is complete in accordance with Chapter II of Annex XV.
2. Within one week of any change occurring in relation to the documentation
referred to in Chapter II of Annex XV, the sponsor shall update the relevant data in
the electronic system referred to in Article 73 and make that change to the
documentation clearly identifiable. The Member State concerned shall be notified
of the update by means of that electronic system.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 57 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

Q Article 71 Assessment by Member States

1. Member States shall ensure that the persons validating and assessing the
application, or deciding on it, do not have conflicts of interest, are independent of
the sponsor, the investigators involved and of natural or legal persons financing the
clinical investigation, as well as free of any other undue influence.
2. Member States shall ensure that the assessment is done jointly by an appropriate
number of persons who collectively have the necessary qualifications and
experience.
3. Member States shall assess whether the clinical investigation is designed in such
a way that potential remaining risks to subjects or third persons, after risk
minimization, are justified, when weighed against the clinical benefits to be
expected. They shall, while taking into account applicable CS or harmonised
standards, examine in particular:
(a) the demonstration of compliance of the investigational device(s) with the
applicable general safety and performance requirements, apart from the aspects
covered by the clinical investigation, and whether, with regard to those aspects,
every precaution has been taken to protect the health and safety of the subjects.
This includes, where appropriate, assurance of technical and biological safety
testing and pre-clinical evaluation;
(b) whether the risk-minimisation solutions employed by the sponsor are described
in harmonised standards and, in those cases where the sponsor does not use
harmonised standards, whether the risk-minimisation solutions provide a level of
protection that is equivalent to that provided by harmonised standards;

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 58 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

Q Article 80 Recording and reporting of adverse events that occur during clinical investigations
1. The sponsor shall fully record all of the following:
(a) any adverse event of a type identified in the clinical investigation plan as being
critical to the evaluation of the results of that clinical investigation;
(b) any serious adverse event;
(c) any device deficiency that might have led to a serious adverse event if
appropriate action had not been taken, intervention had not occurred, or
circumstances had been less fortunate;
(d) any new findings in relation to any event referred to in points (a) to (c). ▼B

29-Nov 08:30 Design R Risk Management (Top ISO

& Management, Planning, 13485:2016,
Developmen Analysis, Risk Control, 7.1
t Residual Risk, Risk Review)

R Article 10 General obligations of manufacturers

29-Nov 08:30 Design S Technical Documentation ISO Medical device file

& (inc. Device Classification, 13485:2016, For each medical device type or medical device family, the organization shall
Developmen Route to Conformity, 4.2.3 establish and maintain one
t GSPR, Labelling, UDI, or more files either containing or referencing documents generated to demonstrate
Declaration of Conformity, conformity to the
Design & Manufacturing requirement of this International Standard and compliance with applicable
Processes) regulatory requirements.
The content of the file(s) shall include, but is not limited to:
a) general description of the medical device, intended use/purpose, and labelling,
including any
instructions for use;
b) specifications for product;
c) specifications or procedures for manufacturing, packaging, storage, handling and
distribution;
d) procedures for measuring and monitoring;
e) as appropriate, requirements for installation;
f) as appropriate, procedures for servicing.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 59 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

S ANNEX I.1 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

1. Devices shall achieve the performance intended by their manufacturer and shall
be designed and manufactured in such a way that, during normal conditions of use,
they are suitable for their intended purpose. They shall be safe and effective and
shall not compromise the clinical condition or the safety of patients, or the safety
and health of users or, where applicable, other persons, provided that any risks
which may be associated with their use constitute acceptable risks when weighed
against the benefits to the patient and are compatible with a high level of
protection of health and safety, taking into account the generally acknowledged
state of the art.

S ANNEX I.10.4.5 GENERAL SAFETY AND PERFORMANCE REQUIREMENTS

S ANNEX II TECHNICAL DOCUMENTATION

The technical documentation and, if applicable, the summary thereof to be drawn
up by the manufacturer shall be presented in a clear, organised, readily searchable
and unambiguous manner and shall include in particular the elements listed in this
Annex.

S ANNEX III TECHNICAL DOCUMENTATION ON POST-MARKET SURVEILLANCE

The technical documentation on post-market surveillance to be drawn up by the
manufacturer in accordance with Articles 83 to 86 shall be presented in a clear,
organised, readily searchable and unambiguous manner and shall include in
particular the elements described in this Annex.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 60 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

S ANNEX IV EU DECLARATION OF CONFORMITY

The EU declaration of conformity shall contain all of the following information:
1. Name, registered trade name or registered trade mark and, if already issued, SRN
as referred to in Article 31 of the manufacturer, and, if applicable, its authorised
representative, and the address of their registered place of business where they can
be contacted and their location be established;
2. A statement that the EU declaration of conformity is issued under the sole
responsibility of the manufacturer;
3. The Basic UDI-DI as referred to in Part C of Annex VI;
4. Product and trade name, product code, catalogue number or other unambiguous
reference allowing identification and traceability of the device covered by the EU
declaration of conformity, such as a photograph, where appropriate, as well as its
intended purpose. Except for the product or trade name, the information allowing
identification and traceability may be provided by the Basic UDI-DI referred to in
point 3;
5. Risk class of the device in accordance with the rules set out in Annex VIII;
6. A statement that the device that is covered by the present declaration is in
conformity with this Regulation and, if applicable, with any other relevant Union
legislation that provides for the issuing of an EU declaration of conformity;
7. References to any CS used and in relation to which conformity is declared;
8. Where applicable, the name and identification number of the notified body, a
description of the conformity assessment procedure performed and identification
of the certificate or certificates issued;
9. Where applicable, additional information;
10. Place and date of issue of the declaration, name and function of the person who
signed it as well as an indication for, and on behalf of whom, that person signed,
signature.

S ANNEX IX.2.1
S Article 1
S Article 10 General obligations of manufacturers

S Article 18
S Article 19 EU declaration of conformity
S Article 27
S Article 27
S Article 32 Summary of safety and clinical performance

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 61 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

S Article 51
S Article 52
S Article 61 Clinical evaluation
S Article 8 Use of harmonised standards
1. Devices that are in conformity with the relevant harmonised standards, or the
relevant parts of those standards, the references of which have been published in
the Official Journal of the European Union, shall be presumed to be in conformity
with the requirements of this Regulation covered by those standards or parts
thereof.
The first subparagraph shall also apply to system or process requirements to be
fulfilled in accordance with this Regulation by economic operators or sponsors,
including those relating to quality management systems, risk management, post-
market surveillance systems, clinical investigations, clinical evaluation or post-
market clinical follow-up (‘PMCF’).
References in this Regulation to harmonised standards shall be understood as
meaning harmonised standards the references of which have been published in the
Official Journal of the European Union.
2. References in this Regulation to harmonised standards shall also include the
monographs of the European Pharmacopoeia adopted in accordance with the
Convention on the Elaboration of a European Pharmacopoeia, in particular on
surgical sutures and on interaction between medicinal products and materials used
in devices containing such medicinal products, provided that references to those
monographs have been published in the Official Journal of the European Union.

S Recital 39
S Recital 51

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 62 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 11:00 HR T Competence, Awareness & ISO Human resources

Training - employee 13485:2016, Personnel performing work affecting product quality shall be competent on the
records 6.2 basis of appropriate
education, training, skills and experience.
The organization shall document the process(es) for establishing competence,
providing needed
training, and ensuring awareness of personnel.
The organization shall:
a) determine the necessary competence for personnel performing work affecting
product quality;
b) provide training or take other actions to achieve or maintain the necessary
competence;
c) evaluate the effectiveness of the actions taken;
d) ensure that its personnel are aware of the relevance and importance of their
activities and how
they contribute to the achievement of the quality objectives;
e) maintain appropriate records of education, training, skills and experience (see
4.2.5).

T Article 10 General obligations of manufacturers

29-Nov 11:00 HR U Qualifications PRRC ISO

13485:2016,
6.2

U Article 15
U Recital 34
29-Nov 12:30 V Tour of Manufacturing ISO Planning of product realization
Production (Goods 13485:2016, The organization shall plan and develop the processes needed for product
& Service received/verification 7.1 realization. Planning of
Provision (witness), In-process product realization shall be consistent with the requirements of the other processes
activities & verification of the quality
(witness), Traceability, management system.
Accept & Release) The organization shall document one or more processes for risk management in
product realization.
Records of risk management activities shall be maintained (see 4.2.5).

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 63 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

V ISO Control of production and service provision

13485:2016, Production and service provision shall be planned, carried out, monitored and
7.5.1 controlled to ensure that
product conforms to specification. As appropriate, production controls shall include
but are not limited to:
a) documentation of procedures and methods for the control of production (see
4.2.4);
b) qualification of infrastructure;
c) implementation of monitoring and measurement of process parameters and
product characteristics;
d) availability and use of monitoring and measuring equipment;
e) implementation of defined operations for labelling and packaging;
f) implementation of product release, delivery and post-delivery activities.
The organization shall establish and maintain a record (see 4.2.5) for each medical
device or batch of
medical devices that provides traceability to the extent specified in 7.5.9 and
identifies the amount
manufactured and amount approved for distribution. The record shall be verified
and approved.
In planning product realization, the organization shall determine the following, as
appropriate:
a) quality objectives and requirements for the product;
b) the need to establish processes and documents (see 4.2.4) and to provide
resources specific to the
product, including infrastructure and work environment;
c) required verification, validation, monitoring, measurement, inspection and test,
handling, storage,
distribution and traceability activities specific to the product together with the
criteria for product
acceptance;
d) records needed to provide evidence that the realization processes and resulting
product meet
requirements (see 4.2.5).
The output of this planning shall be documented in a form suitable for the
organization’s method of
operations.
V ISO Traceability
13485:2016, 7.5.9.1 General
7.5.9 The organization shall document procedures for traceability. These procedures shall
define the extent
of traceability in accordance with applicable regulatory requirements and the
records to be maintained
(see 4.2.5).

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 64 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

V ISO Monitoring and measurement of product

13485:2016, The organization shall monitor and measure the characteristics of the product to
8.2.6 verify that product
requirements have been met. This shall be carried out at applicable stages of the
product realization
process in accordance with the planned and documented arrangements and
documented procedures.
Evidence of conformity to the acceptance criteria shall be maintained. The identity
of the person
authorizing release of product shall be recorded (see 4.2.5). As appropriate, records
shall identify the
test equipment used to perform measurement activities.
Product release and service delivery shall not proceed until the planned and
documented arrangements
have been satisfactorily completed.
For implantable medical devices, the organization shall record the identity of
personnel performing any
inspection or testing.

V ANNEX IX.2.4
V ANNEX IX.3.5 QUALITY MANAGEMENT SYSTEM
►C1 In the case of class IIa and class IIb devices, the surveillance assessment shall
also include an assessment of the technical documentation as specified in Section 4
for the device or devices concerned on the basis of further representative samples
chosen in accordance with the rationale documented by the notified body in
accordance with the third paragraph of Section 2.3. ◄
In the case of class III devices, the surveillance assessment shall also include a test
of the approved parts and/or materials that are essential for the integrity of the
device, including, where appropriate, a check that the quantities of produced or
purchased parts and/or materials correspond to the quantities of finished devices.

V ANNEX IX.3.7 If the notified body finds a divergence between the sample taken from the devices
produced or from the market and the specifications laid down in the technical
documentation or the approved design, it shall suspend or withdraw the relevant
certificate or impose restrictions on it.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 65 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

V ANNEX VII REQUIREMENTS TO BE MET BY NOTIFIED BODIES

4.5.1 General
The notified body and its personnel shall carry out the conformity assessment
activities with the highest degree of professional integrity and the requisite
technical and scientific competence in the specific fields.
The notified body shall have expertise, facilities and documented procedures that
are sufficient to effectively conduct the conformity assessment activities for which
the notified body in question is designated, taking account of the relevant
requirements set out in Annexes IX to XI, and in particular all of the following
requirements:
— appropriately plan the conduct of each individual project,
— ensure that the composition of the assessment teams is such that there is
sufficient experience in relation to the technology concerned, and that there is
continuous objectivity and independence, and to provide for rotation of the
members of the assessment team at appropriate intervals,
— specify the rationale for fixing time limits for completion of conformity
assessment activities,
— assess the manufacturer's technical documentation and the solutions adopted to
meet the requirements laid down in Annex I,
— review the manufacturer's procedures and documentation relating to the
evaluation of pre-clinical aspects,
— review the manufacturer's procedures and documentation relating to clinical
evaluation,
— address the interface between the manufacturer's risk management process and
its appraisal and analysis of the pre-clinical and clinical evaluation and to evaluate
their relevance for the demonstration of conformity with the relevant requirements
in Annex I,
— carry out the specific procedures referred to in Sections 5.2 to 5.4 of Annex IX,
— in the case of class IIa or class IIb devices, assess the technical documentation of
devices selected on a representative basis,
— plan and periodically carry out appropriate surveillance audits and assessments,
carry out or request certain tests to verify the proper functioning of the quality
management system and to perform unannounced on site audits,
— relating to the sampling of devices, verify that the manufactured device is in
conformity with the technical documentation; such requirements shall define the
relevant sampling criteria and testing procedure prior to sampling,
— evaluate and verify a manufacturer's compliance with relevant Annexes.
V Article 10 General obligations of manufacturers

V Article 20 CE marking of conformity

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 66 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

V Article 25 Identification within the supply chain

1. Distributors and importers shall co-operate with manufacturers or authorised
representatives to achieve an appropriate level of traceability of devices.
2. Economic operators shall be able to identify the following to the competent
authority, for the period referred to in Article 10(8):
(a) any economic operator to whom they have directly supplied a device;
(b) any economic operator who has directly supplied them with a device;
(c) any health institution or healthcare professional to which they have directly
supplied a device.

29-Nov 12:30 W Infrastructure & Work ISO Infrastructure

Production Environment 13485:2016, The organization shall document the requirements for the infrastructure needed to
& Service 6.3 achieve
Provision conformity to product requirements, prevent product mix-up and ensure orderly
handling of product.
Infrastructure includes, as appropriate:
a) buildings, workspace and associated utilities;
b) process equipment (both hardware and software);
c) supporting services (such as transport, communication, or information systems).
The organization shall document requirements for the maintenance activities,
including the interval
of performing the maintenance activities, when such maintenance activities, or lack
thereof, can affect
product quality. As appropriate, the requirements shall apply to equipment used in
production, the
control of the work environment and monitoring and measurement.

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 67 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

W ISO Work environment and contamination control

13485:2016, 6.4.1 Work environment
6.4 The organization shall document the requirements for the work environment
needed to achieve
conformity to product requirements.
If the conditions for the work environment can have an adverse effect on product
quality, the
organization shall document the requirements for the work environment and the
procedures to monitor
and control the work environment.
The organization shall:
a) document requirements for health, cleanliness and clothing of personnel if
contact between such
personnel and the product or work environment could affect medical device safety
or performance;
b) ensure that all personnel who are required to work temporarily under special
environmental
conditions within the work environment are competent or supervised by a
competent person.

W Article 10
29-Nov 12:30 X Calibration & Maintenance ISO
Production 13485:2016,
& Service 6.3
Provision

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 68 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

X ISO Control of monitoring and measuring equipment

13485:2016, The organization shall determine the monitoring and measurement to be
7.6 undertaken and the
monitoring and measuring equipment needed to provide evidence of conformity of
product to
determined requirements.
The organization shall document procedures to ensure that monitoring and
measurement can be
carried out and are carried out in a manner that is consistent with the monitoring
and measurement
requirements.
As necessary to ensure valid results, measuring equipment shall:
a) be calibrated or verified, or both, at specified intervals, or prior to use, against
measurement
standards traceable to international or national measurement standards: when no
such standards
exist, the basis used for calibration or verification shall be recorded (see 4.2.5);
b) be adjusted or re-adjusted as necessary: such adjustments or re-adjustments
shall be recorded
(see 4.2.5);
c) have identification in order to determine its calibration status;
d) be safeguarded from adjustments that would invalidate the measurement result;
e) be protected from damage and deterioration during handling, maintenance and
storage.

X Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 69 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 15:00 Supply Y Outsourced Process (inc. ISO When the organization chooses to outsource any process that affects product
Chain Authorized Rep, Importers, 13485:2016, conformity to
Distributors, Traceability) 4.1.5 requirements, it shall monitor and ensure control over such processes. The
organization shall retain
responsibility of conformity to this International Standard and to customer and
applicable regulatory
requirements for outsourced processes. The controls shall be proportionate to the
risk involved and the
ability of the external party to meet the requirements in accordance with 7.4. The
controls shall include
written quality agreements.

Y ISO
13485:2016,
7.5.9

Y ANNEX IX.2.1
Y ANNEX IX.2.2

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 70 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

Y ANNEX VII 4.9 Changes and modifications

The notified body shall have documented procedures and contractual
arrangements with manufacturers in place relating to the manufacturers'
information obligations and the assessment of changes to:
— the approved quality management system or systems or to the product-range
covered,
— the approved design of a device,
— the intended use of or claims made for the device,
— the approved type of a device, and
— any substance incorporated in or utilised for the manufacturing of a device and
being subject to the specific procedures in accordance with Section 4.5.6.
The procedures and contractual arrangements referred to in the first paragraph
shall include measures for checking the significance of the changes referred to in
the first paragraph.
In accordance with its documented procedures, the notified body in question shall:
— ensure that manufacturers submit for prior approval plans for changes as
referred to in the first paragraph and relevant information relating to such changes,
— assess the changes proposed and verify whether, after these changes, the quality
management system, or the design of a device or type of a device, still meets the
requirements of this Regulation, and
— notify the manufacturer of its decision and provide a report or as applicable a
supplementary report, which shall contain the justified conclusions of its
assessment.

Y Article 10 General obligations of manufacturers

Y Article 11
Y Article 12
Y Article 13
Y Article 14
Y Article 16
Y Article 25
Y Article 27
Y Recital 35

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 71 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 15:00 Supply Z Supplier Selection, ISO Purchasing process

Chain Evaluation & Monitoring 13485:2016, The organization shall document procedures (see 4.2.4) to ensure that purchased
7.4.1 product conforms to specified
purchasing information.
The organization shall establish criteria for the evaluation and selection of suppliers.
The criteria shall be:
a) based on the supplier’s ability to provide product that meets the organization’s
requirements;
b) based on the performance of the supplier;
c) based on the effect of the purchased product on the quality of the medical
device;
d) proportionate to the risk associated with the medical device.
The organization shall plan the monitoring and re-evaluation of suppliers. Supplier
performance in meeting
requirements for the purchased product shall be monitored. The results of the
monitoring shall provide an input into
the supplier re-evaluation process.
Non-fulfilment of purchasing requirements shall be addressed with the supplier
proportionate to the risk associated
with the purchased product and compliance with applicable regulatory
requirements.

Z ANNEX VII 4.9

Z Article 10 General obligations of manufacturers

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 72 of 73

 ANNEX References Table

Date Time and Section Overview Reg./or Standard 13485 / MDR Clauses
activity Standard
Reference

29-Nov 15:00 Supply AA Purchasing Information ISO Purchasing information

Chain (inc. Repackaging 13485:2016, Purchasing information shall describe or reference the product to be purchased,
Requirements) 7.4.2 including as
appropriate:
a) product specifications;
b) requirements for product acceptance, procedures, processes and equipment;
c) requirements for qualification of supplier personnel;
d) quality management system requirements.
The organization shall ensure the adequacy of specified purchasing requirements
prior to their
communication to the supplier.
Purchasing information shall include, as applicable, a written agreement that the
supplier notify the
organization of changes in the purchased product prior to implementation of any
changes that affect
the ability of the purchased product to meet specified purchase requirements.
To the extent required for traceability given in 7.5.9, the organization shall maintain
relevant purchasing
information in the form of documents (see 4.2.4) and records (see 4.2.5).

AA Article 10 General obligations of manufacturers

AA Article 27
30-Nov 08:30 UKCA BB UKCA Technical File UK MDR 2002
Tech File (including labeling), MHRA
Registration, UK
Responsible Person,
Internal Audit (UK MDR
2002)

file:///conversion/tmp/activity_task_scratch/775570989.xlsx Confidential Page 73 of 73