Many of you may have heard of the “extension to the MDR transition period” which the EU has recently agreed.  This is intended to ensure that European hospitals, health care providers and patients can continue to have access to medical devices that may have not yet been re-certified under the EU MDR by a Notified Body.  

The European Parliament on Thursday 16 February 2023 approved a proposal to amend (EU) MDR 2017/745 regarding the transitional provisions for certain medical devices.

The amendment allows ‘legacy devices’ to be placed on the market or put into service until the following dates, subject to certain conditions:

• 31 December 2027 - Class III and Class IIb implantable devices (with some exceptions).

• 31 December 2028 - Other Class IIb devices, Class IIa and Class I (sterile or having a measuring function).

‘Legacy devices’ are either:

(1) devices with EU MDD or EU AIMDD certificates valid on 26 May 2021; or

(2) devices that do not require Notified Body involvement under MDD but are ‘up-classified’ to require Notified Body involvement under (EU) MDR 2017/745, and have a declaration of conformity drawn up prior to 26 May 2021.

Conditions set out for the extension to apply are as follows:

1. Your device must be a ‘legacy device’ and have had no significant change in design or intended purpose between 26 May 2021 and the date of your MDR compliance (when you apply to a Notified Body).

2. You must put in place a quality management system (QMS) in accordance with Article 10(9) of (EU) MDR 2017/745 no later than 26 May 2024. The recommended QMS standard is EN ISO 13485:2016 + A11:2021 including additional MDR QMS requirements in its Annexes.

3. Your QMS must include procedures and reports to ensure compliance with MDR 2017/745 requirements for post-market surveillance, vigilance and registration.

4. You must have all of your EU MDR compliant documentation ready before 26 May 2024.

5. You must have formally applied to a Notified Body for certification by 26 May 2024.

6. You must have progressed to having a written agreement in place with the Notified Body by 26 September 2024. You should contact your chosen Notified Body who will supply you with the documentation to be completed. You must receive and hold a confirmation letter from your Notified Body indicating that you have met these timelines.

7. You must establish with your national Competent Authority, or that of your EU Authorised Representative, that your devices do not present an unacceptable risk to health or safety. The process should be as follows:

• Contact the Competent Authority with details of your completed EU MDR compliance for the devices.

• Provide information for review which may include vigilance data, post-market surveillance reports and Notified Body audit information.

• The Competent Authority will issue an acceptance letter when satisfied that there is no unacceptable risk to placing the device on the market.

NOTE: The extension only applies to devices that are ‘in transition’ from the EU MDD or EU AIMDD to the EU MDR 2017/745. A reasonable period to bring the device into compliance with (EU) MDR 2017/745 (i.e. to obtain Notified Body certification) will be defined by the Competent Authority (generally 12 months).

Devices not eligible for the transition period

• Devices that were Class I self-certified under EU MDD at the time of EU MDR 2017/745 application. MDR compliance for such devices has been required since 26 May 2021. 

• Any new Class I devices developed and placed on the market after 26 May 2021. 

References:

• MDCG 2022-18 ‘MDCG Position paper on the application of Article 97 MDR to ‘legacy devices’.

• MDCG 2021-25 ‘Regulation (EU) 2017/745 – application of MDR requirements to ‘legacy devices’.

• C9-0003/2023 ‘Proposal for amending Regulations (EU) 2017/745 and (EU) 2017/746.

The team at Psephos are happy to help with your EU MDR compliance before the deadline for application to Notified Bodies of 26 May 2024.

Please contact Jane or Marie at rep@psephos.com