EUROPEAN TECHNICAL FILES FOR

CE MARKING OF MEDICAL DEVICES

An Overview of the Technical File Preparation Process

Author
Evangeline Loh, Ph.D.
Vice President of Global Regulatory Affairs
USA Office
www.EmergoGroup.com

19 November 2015
So you want to sell your medical device in Europe?
If you’re reading this, chances are good that you’re considering introducing a device in Europe.
Maybe you have been tasked with preparing a technical file. Whatever the case, in this white paper,
we will discuss the purpose of a technical file, the data and documentation included, and formatting,
among other topics.

What is a Technical File?

A CE Technical File is a comprehensive description of your device and demonstrates compliance with
the requirements of the applicable European Union Directive, such as the Medical Devices Directive
93/42/EEC (MDD), In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) or Active
Implantable Medical Devices Directive 90/385/EEC (AIMDD).

Compiling your technical file (or Design Dossier for Class III devices) is a critical step in the CE
Marking process and includes detailed information about the design, function, composition, use,
claims, and clinical evaluation of your medical device.

Brief Overview: CE Marking Process for Devices under the MDD

Preparing and submitting the technical file is just one step in the CE Marking process. Early steps in
the regulatory procedure determine if a Notified Body is required to review your technical file or
design dossier and what information to include in your submission. Basic steps in the CE Marking
process are listed below:

1. Determine if your product is a medical device and which EU Directive applies to your
device: Medical Devices Directive (MDD), In Vitro Diagnostic Device Directive (IVDD) or
Active Implantable Medical Device Directive (AIMDD)?
2. Determine the classification of your device: Class I (non-sterile, non-measuring), Class I
(sterile, measuring), Class IIa, Class IIb or Class III.
3. Implement a Quality Management System (QMS). Exception: Class I (non-sterile, non-
measuring) devices.
4. Prepare a Technical File for your device (Class I, IIa, IIb) or Design Dossier (Class III).
5. Select an Authorized Representative (EC REP) if you have no location in Europe.
6. Have your QMS and Technical File/Design Dossier audited by a Notified Body, unless
your device is Class I non-sterile, non-measuring.
7. Upon successful completion of your Notified Body audit, you will receive a European CE
Marking certificate (and an ISO 13485 certificate depending on the route to conformity
assessment selected). There may be some registration requirements, though this is
contingent upon the Competent Authority where your Authorized Representative is
based, as well as the classification of your devices.

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 8. Prepare the Declaration of Conformity (DoC), which states that your device complies
with the appropriate Directive.
Identifying the appropriate device classification before you begin work on your technical file is
important. For example, you may need to include detailed clinical data and test reports, depending
on your device’s risk level. If you have a low-risk device, your technical file will have fewer
requirements.

Essential Requirements, Classification, and Conformity Assessment

No two technical files will look exactly the same because the type of device dictates the information
included in the document. Three primary factors determine what is required for your technical file:

Essential Requirements. The Essential Requirements establish basic characteristics that you must
comply with to mitigate risk to the user /patient, supplying information and documentation with
your device, and labeling your device. These can be found in Annex I of the MDD. Overall, the
Essential Requirements apply to all medical devices. However, some specific requirements apply
only to certain device types, such as measuring devices or those using radiation or electricity.
Manufacturers generally use standards to address compliance, and particularly European Norm
harmonized standards published in the Official Journal of the European Union (OJ).

Device classification. Device classification further dictates the contents of a technical file or design
dossier. The European device classification scheme follows a risk continuum: lowest risk devices are
Class I (non-sterile, non-measuring) and the highest risk devices are Class III. However, the factors
that determine risk level are complex. The classification of your device defines, in part, your device’s
“route” to conformity assessment, as the MDD indicates additional conformity requirements based
on your classification. Once your device is properly classified, you can accurately identify the rules
that apply to your device. Classification criteria can be found in Annex IX of the MDD.

Conformity assessment. Conformity assessment is the purpose of the technical file: the information
in the file should demonstrate that your device conforms to the rules laid out for your device type
and class in the MDD. These rules relate to every aspect of your device’s lifecycle: from design and
function to quality systems and manufacturing. In formal terms, conformity assessment refers to the
Notified Body audit referred to in Step 6 of the registration process. However, some low-risk devices
are not required to complete the audit. In this case, a thorough technical file should prove your
compliance and you should feel confident signing a DoC. Conformity assessment procedures are
discussed in Article 11 of the MDD.

According to paragraph 10, Article 11 of the MDD, the “notified body may require, where duly
justified, any information or data, which is necessary for establishing and maintaining the
attestation of conformity in view of the chosen procedure." In other words, you should provide any
information requested by the NB to demonstrate that your device conforms with the Essential

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Requirements. If you believe specific requirements do not apply to your device, you must justify
your position with sufficient data to assure the device complies with the Directive.

Common Elements of a Technical File/ Design Dossier

Consider a technical file as a narrative document divided into sections. The reports or documents
supporting the contents of the sections and the ER should be appended to the technical file as
attachments. In certain circumstances, these supporting files may be referenced. The following
elements are recommended, though this list is not exhaustive nor prescriptive:

Description of the device. This section might include the following information: design,
characteristics, performances, representative images, intended purpose, patient population,
medical condition, accessories, brief market history, classification (see Annex IX, Classification
Criteria) and rationale, as well as the selected conformity assessment route. You may also add data
about the device's materials.

The Essential Requirements (ER) checklist. The ER checklist should be reproduced verbatim from
the directive and presented as a table with labeled columns such as ER, applicable applied standard,
demonstration of compliance, and location of documentation. Address each ER and indicate
whether it is applicable. If the ER is applicable, reference the standard or procedure used. Name the
explicit document meeting the requirement and its location – the reviewer should be able to
identify the specific document. If the ER is not applicable, provide an explanation supporting your
position. The ER checklist functions as a signpost that provides identification and location of the
supporting documentation.

Note: The ER checklist should guide design and development of the medical device, as
failure to align with the Essential Requirements will inhibit the marketability of your device
in Europe until conformity is achieved.

Risk assessment. In this section, discuss conclusions and outcomes from risk assessment activities.
The risk assessment document should be included as an attachment. (Use of EN ISO 14971:2012 is
strongly encouraged, as NBs will expect a manufacturer to comply with that standard.)

Bench testing. Include a synopsis from test reports (if applicable) that substantiate the device's
performance and safety: in-vitro performance or safety; mechanical, physical, chemical and/or
animal studies; biocompatibility; packaging; shelf life; stability; and sterilization. (Note: You may
address packaging, shelf life, and sterilization in separate sections.)

Manufacturing. Provide a manufacturing flow chart and rudimentary description of the method of
manufacturing to demonstrate inspection and preventive monitoring steps, conditions of
manufacture, quality system certifications held by the manufacturer or critical subcontractors,
labeling control, and traceability. A flow chart is useful when contractors perform multiple functions
or when the manufacturer relies heavily on outsourcing.

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Clinical evaluation. This section is a summary of the Clinical Evaluation Report (CER), with the full
CER attached to the summary. When Directive 2007/47/EC was transposed into national law in
December 2008 and applied in March 2010, all medical devices seeking CE Marking were required to
produce a CER, regardless of their classification. CERs will be discussed in greater detail later in this
paper.

Labeling. Include a draft of your device’s labeling. You may also include the CE marking with the
four-digit NB identification number, if relevant. Use of symbols, particularly those described within
EN 980, are encouraged.

Declaration of Conformity. Issue this document as a draft; however, each NB and reviewer may
have its own expectations as to what the document should contain. The DoC draft, which could
reference the NB-issued CE marking certificate number, is signed and issued after the manufacturer
has met all the requirements of the directive. DoCs will be discussed in greater detail later in this
paper.

Clinical Evaluation Reports

As previously discussed, all medical device manufacturers are required to produce a compliant
Clinical Evaluation Report (CER). The CER documents results of the clinical evaluation of your
device. A compliant CER demonstrates that the clinical evaluation process conforms with that
outlined by the MDD. The evaluation process should support strong clinical evidence that your
device achieves its intended purpose without exposing users and patients to further risk.

Approach the CER as a standalone document even though you will include it as an attachment to
your technical file or design dossier. A list of possible elements to include in your report, as
recommended in the Guidelines on Medical Device 2.7.1 rev. 3, Appendix E. is as follows:

 General information: device and manufacturer name

 Concise physical and technical device description and intended application

 Outline of intended therapeutic or diagnostic claims

 Clinical evaluation and data types

 Summary of clinical data and review

 Describe analyses used to assess performance, safety, and relevance/accuracy of product

literature
 Conslusions about safety, performance, and conformity

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 Note: You are required to prepare and submit a CER for NB review with your technical file
as part of the CE Marking/conformity assessment process. However, this is just the
beginning of your CER’s lifecycle. Consistent updates to the CER should occur from ongoing
clinical evaluations, if needed, or as part of your post-market surveillance and vigilance
operations.

Declaration of Conformity
The Declaration of Conformity (DoC) is a legally binding document that declares you are in
compliance with all the applicable legislation necessary to sell your product in the European Union.
Specifically, it states that your device conforms with the Essential Requirements and the MDD. All
medical device manufacturers must complete a DoC, regardless of their device’s classification.

Elements of a DoC vary depending on the guidance of your Notified Body. And, there is no
mandatory format. Nonetheless, it should be printed on company letterhead and written in one of
the European Union’s official languages, which includes English. Although the DoC is a short
document, it should clearly convey that your company and device conform to the necessary
requirements. Most DoCs include the following elements:

 Device trade name and model number

 Device classification (Class and Rule)
 Your company name and address

 Name of quality management representative

 Notified Body name and ID number (if applicable)

 CE certificate number (if applicable)
 Date CE Marking was first applied
 Authorized Representative contact information

 Route to compliance (example: Annex II, V, VII)

 Standards applied (optional)

 Name and signature of company officer

The DoC is prepared and signed as the last step in the regulatory process. However, some NBs
require a sample DoC with your Technical File. The sample DoC should not be signed by your
company’s senior executive until you have passed the conformity assessment, where applicable.

Technical File Guidances & References

A guidance document is an “official recommendation” from a regulatory entity for how to approach
device submissions. Many entities publish guidance documents on the topic of technical file content

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and formatting. While you are not required to follow guidance documents, it is highly
recommended, as they may reduce the need to make changes and corrections to your technical file
during the conformity assessment.

Guidance from Notified Bodies

Some NBs publish extensive documents describing their position on content and formatting. And,
you can assume the NB reviewer assesses your documentation based on a checklist established
from its guidance documents. If you have already identified a NB, you may want to request guidance
from the NB as well. NBs have unique expectations about the appearance of technical files, so keep
this in mind should you change NBs during the conformity assessment process. For this reason,
changing NBs should be avoided.

Technical files and design dossiers are viewed as controlled documents, for the most part. NBs
expect clearly numbered pages for easy identification and review. Present your information in an
organized, concise, and coherent manner to facilitate evaluation by the NB, using synopses and
conclusions, if applicable. Tables and flow charts are effective tools to provide summary results.
Generally, documents that demonstrate compliance with the ER are summarized in the text of the
technical file or design dossier and included as an attachment or appendix.

Summary Technical Document Preparation

Summary TEchnical Document (STED) is a harmonized format for submitting information for
regulatory approval of devices. The format was created by the former Global Harmonization Task
Force (GHTF) to harmonize the regulatory requirements among different jurisdictions (GHTF
members include Australia, Canada, the European Union, Japan, and the United States, as well as
other signatories).

STED may be used to describe how the device was developed, designed, and manufactured, and
also to demonstrate how the device meets the "Essential Principles of Safety and Performance of
Medical Devices." Then it may be submitted as the regulatory documentation for all GHTF members,
not withstanding country specific requirements.

STED guidance documents often provide detailed instructions about formatting your submission as
well. You can expect instructions about the required information and how to organize it, as well as
how to quote and cite references. You will also find specific instructions about how to format your
document, from paper and font sizes to printing and page numbering.

Conclusion
Quality preparation is essential to the success of your technical file. Lay a firm foundation for the
project by identifying the applicable directive, accurately classifying your device, and identifying the
appropriate route to conformity. Carefully choose your Notified Body and heed the directions
provided in guidance documents. Most of all, reference conformity and regulatory requirements
early in your endeavor to avoid any surprises or costly corrections.

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To learn more:
Emergo helps medical device companies with regulatory compliance and market access worldwide,
including the preparation of technical files and design dossiers. To learn more, visit
http://www.emergogroup.com/services/europe/technical-file-preparation

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