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230609-Final MDR Manufacturer-Declaration

This document is a manufacturer's declaration that provides information on medical devices that were previously certified under older EU directives but are transitioning to comply with new regulations. It contains: 1) Identification information for the manufacturer and authorized representatives. 2) A list of medical device models or types, their original directive certificates and expiration dates, and notified body information if applicable. 3) Statements from the manufacturer declaring they meet conditions for continued marketing of the devices during the transition period to the new regulations, such as maintaining compliance with the older directives, not making significant design changes, and not posing new risks. 4) Signatures and contact information for the individual authorized to sign on behalf of the manufacturer.

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333 views6 pages

230609-Final MDR Manufacturer-Declaration

This document is a manufacturer's declaration that provides information on medical devices that were previously certified under older EU directives but are transitioning to comply with new regulations. It contains: 1) Identification information for the manufacturer and authorized representatives. 2) A list of medical device models or types, their original directive certificates and expiration dates, and notified body information if applicable. 3) Statements from the manufacturer declaring they meet conditions for continued marketing of the devices during the transition period to the new regulations, such as maintaining compliance with the older directives, not making significant design changes, and not posing new risks. 4) Signatures and contact information for the individual authorized to sign on behalf of the manufacturer.

Uploaded by

mochkurniawan
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as DOCX, PDF, TXT or read online on Scribd
You are on page 1/ 6

Declaration, including the attached schedule, should be printed on form as used for a Declaration of

Conformity per manufacturer’s QMS (e.g. manufacturer’s letterhead)

Manufacturer’s Declaration

in relation to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745 and (EU) 2017/746 as
regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices, in
particular with respect to
 the validity of certificates issued under Council Directive 90/385/EEC on Active Implantable
Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive
Certificates) and/or1
 the compliance of the devices and us as their manufacturer with the conditions for the continued
placing on the market and putting into service

Manufacturer name

Manufacturer address and contact details

Single Registration Number (SRN) (if available)

Authorised Representative name (if applicable)

Authorised Representative address and contact details

Single Registration Number (SRN) (if available)

Notified body name (if applicable)


□ See attached schedule

Notified body number (if applicable)


□ See attached schedule

Directive Certificate number(s)


to which this confirmation is made (if applicable) □ See attached schedule

Original expiry date as indicated on the Directive


Certificate prior to the extension of the validity (if
applicable) □ See attached schedule

1
The first condition is not applicable in case of devices for which the conformity assessment procedure pursuant to MDD did not
require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which
the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body.

Page 1 of 6
Declaration, including the attached schedule, should be printed on form as used for a Declaration of
Conformity per manufacturer’s QMS (e.g. manufacturer’s letterhead)

End date of extended validity/transition period


□ See attached schedule

We, as the manufacturer declare under our sole responsibility:


 for the above listed Directive Certificate (or see attached schedule, if multiple certificates) the
conditions for the legal extension of validity as required in Article 120.2 of the MDR are met
and/or2
 the listed device(s) in the attached schedule and we as their manufacturer are in compliance with
the conditions listed in Article 120.3c of the MDR for continued placing on the market and putting
into service,
namely by fulfilling the following conditions:

 Directive Certificate(s) as listed above or in the attached schedule


 Directive Certificate(s) covering the listed device(s) was/were issued after 25 May 2017,
was/were valid on 26 May 2021 and have not been withdrawn afterwards.
Choose applicable statements:
 Expired before 20 March 2023:
 Before the original date of expiry as indicated on the Directive Certificate(s), we and the
notified body have signed written agreement(s) in accordance with Section 4.3, second
subparagraph of Annex VII to this Regulation for the conformity assessment(s) in respect
of the device(s) covered by the expired certificate(s) or in respect of a device(s) intended
to substitute that/those device(s), or
 A Competent Authority has granted a derogation from the applicable conformity assess -
ment procedure in accordance with Article 59(1) MDR (may be provided upon request),
or
 A Competent Authority has required the manufacturer, in accordance with Article 97(1)
MDR, to carry out the applicable conformity assessment procedure (may be provided
upon request)
Choose one of the following statements only if a derogation per Article 59(1) or a requirement
per Article 97(1) has been granted by a Competent Authority:
 Formal application(s) to the notified body in accordance with Section 4.3, first subpara -
graph of Annex VII MDR for conformity assessment has/have been made or will be
made/submitted by us to a notified body no later than 26 May 2024 for the device(s) listed
in the attached schedule or its/their substitute(s) and signed written agreement(s) is/will
be in place in accordance with Section 4.3, second subparagraph of Annex VII MDR
before 26 September 2024.
 We do not intent to lodge an application for conformity assessment by 26 May 2024,
therefore the transition period will end on 26 May 2024.

2
The first condition is not applicable in case of devices for which the conformity assessment procedure pursuant to MDD did not
require the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26 May 2021 and for which
the conformity assessment procedure pursuant to this Regulation requires the involvement of a notified body

Page 2 of 6
Declaration, including the attached schedule, should be printed on form as used for a Declaration of
Conformity per manufacturer’s QMS (e.g. manufacturer’s letterhead)

Page 3 of 6
Declaration, including the attached schedule, should be printed on form as used for a Declaration of
Conformity per manufacturer’s QMS (e.g. manufacturer’s letterhead)

 Expired/expires after 20 March 2023:


Choose one applicable statement:
 Formal application(s) to the notified body in accordance with Section 4.3, first subpara -
graph of Annex VII MDR for conformity assessment has/have been made or will be
made/submitted by us to a notified body no later than 26 May 2024 for the device(s) listed
in the attached schedule or its/their substitute(s) and signed written agreement(s) is/will
be in place in accordance with Section 4.3, second subparagraph of Annex VII MDR
before 26 September 2024.
 We do not intent to lodge an application for conformity assessment by 26 May 2024,
therefore the transition period will end on 26 May 2024.
 Upclassified devices
In case of devices for which the conformity assessment procedure pursuant to MDD did not require
the involvement of a notified body, for which the declaration of conformity was drawn up prior to 26
May 2021 and for which the conformity assessment procedure pursuant to this Regulation requires
the involvement of a notified body:
Choose one applicable statement:
 Formal application(s) to the notified body in accordance with Section 4.3, first subparagraph
of Annex VII MDR for conformity assessment has/have been made or will be made/submitted
by us to a notified body no later than 26 May 2024 for the device(s) listed in the attached
schedule or its/their substitutes and signed written agreement(s) is/will be in place in
accordance with Section 4.3, second subparagraph of Annex VII MDR before 26 September
2024.
 We do not intent to lodge an application for conformity assessment by 26 May 2024,
therefore the transition period will end on 26 May 2024.
 Quality Management System (QMS)
Choose one applicable statement:
 A QMS in accordance with Article 10(9) MDR will be put in place by no later than 26 May
2024.
 A QMS in accordance with Article 10(9) MDR is in place.
 A notified body has issued the attached certificate for the MDR-compliant QMS.
 Device(s) as listed in the attached schedule
 The device(s) continue to comply with the AIMDD or MDD.
 There are no significant changes in the design and intended purpose.
 The device(s) do not present an unacceptable risk to health or safety of patients, users or other
persons, or to other aspects of the protection of public health.

Signed for and on behalf of the manufacturer:


Full Company Name
Location & Date
Signature, Print Name, Title

Page 4 of 6
Declaration, including the attached schedule, should be printed on form as used for a Declaration of
Conformity per manufacturer’s QMS (e.g. manufacturer’s letterhead)

Contact Details (at least email)

Page 5 of 6
Declaration, including the attached schedule, should be printed on form as used for a Declaration of Conformity per manufacturer’s QMS (e.g.
manufacturer’s letterhead)

Schedule of Devices

The above Manufacturer’s Declaration is valid for the following devices:

Identification of Directive Original expiry Notified Body Notified Body End date of Substitute
the device(s)3 Certificate date as name and name and extended validity / Device(s)
(e.g., device name, number(s) indicated on the number that number where transition period (if applicable)
family/group name to which this Directive issued the the MDR
device model or confirmation is Certificate (s) Directive application was
catalogue number) made prior to the Certificate lodged/contract
(if applicable) extension of the (if applicable) signed
validity (if applicable)
(if applicable)

3
for devices with AIMDD/MDD certificate(s) the identification should be as in the certificate, and only if the certificate has a generic scope it should be as defined
above)

Page 6 of 6

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