MDR Extension Regulation (EU) 2023/607

• Extended validity of AIMDD/MDD certificates to 31 December 2027 (Class III, Class IIb implantables except sutures/staples/dental fillings/dental braces/tooth crowns/screws/wedges/plates/wires/pins/clips/connectors) or 31 December 2028 (other classes plus Class I that became up-classified under MDR).
• Made the extension conditional on the manufacturer meeting strict transitional conditions (see below).
• Deleted the 27 May 2025 sell-off date in MDR Article 120(4) — legacy devices already placed on the market or put into service can continue to be made available indefinitely.
• Did NOT extend the application date of MDR. MDR has applied since 26 May 2021.

The extension is not automatic. To benefit, manufacturers must:

1. Hold a valid AIMDD/MDD certificate as of 26 May 2021 (or one that expired between 26 May 2021 and 20 March 2023 with arrangements in place).
2. Continue to comply with the AIMDD/MDD they were certified under.
3. Make no significant change in design or intended purpose of the device.
4. Devices must not present unacceptable risk to health and safety of patients, users or others.
5. Manufacturers must, by 26 May 2024, have a QMS in place that complies with MDR.
6. Manufacturers must, by 26 May 2024, have lodged a formal application with a Notified Body for MDR certification.
7. By 26 September 2024, a written agreement must be in place between manufacturer and Notified Body for the conformity assessment.

Notified Body capacity was the central problem. By late 2022 the available capacity across designated MDR Notified Bodies was far below the certification volume needed by the May 2024 original transition cliff. Real risk of device shortages — particularly orphan and paediatric devices, and devices from small manufacturers — drove the Council and Parliament to fast-track 2023/607. The trade-off: legacy devices stay on the market longer, but manufacturers must demonstrate active progress toward MDR.

• MDR substantive requirements (GSPR, technical documentation, clinical evaluation, PMS, PSUR, EUDAMED) are unchanged.
• No extension for Notified Body re-designation timelines.
• No extension for IVDR — that came separately via Regulation (EU) 2024/1860.
• No relief from PMS/Vigilance obligations under MDR Article 120 for legacy devices in the transition.

• Operate under AIMDD/MDD for the device's certification and labelling, AND under MDR for PMS, vigilance, registration, economic operator obligations and post-market clinical follow-up.
• EUDAMED registration of devices, UDI assignment and economic-operator declarations remain MDR obligations during transition.
• No 'significant changes' in design or intended purpose — guidance MDCG 2020-3 governs what counts as significant.
• Demonstrate to the Notified Body and competent authorities that the QMS, application and written agreement timelines have been met.

• '2023/607 extended MDR.' No — MDR applies since 2021. The extension applies to legacy AIMDD/MDD certificates.
• 'I can ignore MDR until 2027/2028.' No — PMS, vigilance, EUDAMED, UDI, economic operator obligations apply now.
• 'No sell-off date means no expiry.' For devices already placed on the market or put into service, yes. New devices cannot be placed on the market under legacy certificates after the deadlines.
• 'My Notified Body is full so I can use someone else.' Switching Notified Bodies mid-application restarts much of the assessment timeline.