Originally published February 2023. Updated November 2026. The extension this article argued for was adopted in March 2023 as Regulation (EU) 2023/607. We added what happened and what it means now, and removed certificate and application counts we could not trace to a public source.
Where things stand in November 2026
The extension happened. The European Parliament and the Council adopted Regulation (EU) 2023/607 in March 2023, and it applied from 20 March 2023. It amended the transitional provisions of the European Union Medical Device Regulation (EU MDR) without changing its requirements:
- Legacy devices (those covered by a certificate or declaration of conformity issued under the old directives before 26 May 2021) can stay on the market until 31 December 2027 for Class III and Class IIb implantable devices, and until 31 December 2028 for other legacy devices.
- The extension came with conditions. Among them, the manufacturer had to have a quality management system meeting the MDR in place and a formal application lodged with a notified body by 26 May 2024, and a written agreement signed with that notified body by 26 September 2024. The devices also could not change significantly in design or intended purpose.
- The “sell-off” date was removed, so devices already placed on the market can continue to be made available.
- Class III custom-made implantable devices got a transition period until 26 May 2026, which has now passed.
The Commission published a Q&A on applying Regulation (EU) 2023/607 that explains the conditions in detail.
More has moved since. Regulation (EU) 2024/1860, published in July 2024, extended the In Vitro Diagnostic Regulation (IVDR) transition, allowed a gradual rollout of the European Database on Medical Devices (EUDAMED), and added a duty for manufacturers to give advance notice of supply interruptions or discontinuations, which has applied since 10 January 2025. The first four EUDAMED modules became mandatory on 28 May 2026. And on 16 December 2025 the Commission proposed a broader targeted revision of the MDR and IVDR, which as of November 2026 is still with the European Parliament’s public health committee.
The original analysis follows, lightly edited. It shows how the case for extension was built, and most of the capacity problems it describes are why the 2027 and 2028 dates exist.
The highlights (as of February 2023)
- Only 36 notified bodies had been designated under the MDR, with 26 more applications for designation pending, according to the European Commission.
- The Commission warned that the May 2024 end of the transition period, and the May 2025 sell-off date, risked shortages of life-saving medical devices for patients.
- On 1 December 2022 the Commission adopted two delegated acts deferring the first complete reassessment of notified bodies, to free up capacity.
- On 6 January 2023 the Commission proposed extending the transition by risk class: to December 2027 for higher-risk devices such as implants, and to December 2028 for medium- and lower-risk devices that need a notified body.
- The Commission acknowledged the challenges around orphan devices and was looking at a special framework so these life-saving devices would keep reaching patients.
A deeper review
On December 9, 2022, the Commission reviewed proposed solutions to the problems in implementing Regulation (EU) 2017/745 on medical devices (MDR). The work followed serious concerns raised by EU health ministers at the Employment, Social Policy, Health and Consumer Affairs (EPSCO) Council on 14 June 2022, after which the Medical Device Coordination Group (MDCG) was asked to identify the challenges and propose solutions for meeting the 2024 MDR transition deadline. The MDCG published MDCG 2022-14, which said action was needed to increase notified body capacity, improve access to notified bodies and avoid device shortages.
To increase notified body capacity, the MDCG called for better use of audits and of auditors' time. That included reducing the frequency of audits required for reassessment, and using hybrid audits to review legacy devices at the time of a manufacturer's certification audit. It also called for platforms such as EUDAMED that make documentation easier to access and share, and reduce double registration where possible. The MDCG also acknowledged that notified bodies needed to streamline their internal requirements and train more personnel.
To reduce confusion for manufacturers, the MDCG asked notified bodies to provide more information upfront about fees and to give better help to first-time applicants. It encouraged manufacturers and notified bodies to hold more structured, frequent dialogue to speed the process, instead of relying on a traditional fee-based meeting approach. The relationship between notified bodies and manufacturers needs to be freer flowing and collaborative, with best practices and lessons learned discussed openly at webinars, workshops and feedback sessions where both sides learn from each other. That would let manufacturers prepare better for their audits and understand what MDR compliance takes. Manufacturers that implemented MDR requirements ahead of the deadlines would have time for proactive, honest conversations with their notified body and could avoid certification delays. Notified bodies, in turn, could use what they learn to help shape future guidance.
Other actions came out of breakout groups on legacy devices, orphan devices, and medical devices incorporating an ancillary medicinal substance. Each offered a chance to improve the process with specific provisions or exceptions. Legacy devices had already shown compliance with the old directives and had a proven track record on the market, which made them the natural target for reduced scrutiny or a longer transition. Orphan devices had proven the most difficult group because of their nature, and we argued they should get an extension until a more formal path to the MDR was in place. For medical devices incorporating an ancillary medicinal substance, the MDCG called for expedited review by medicines authorities, especially for substances already approved under the old directives.
The Commission said many efforts were already under way, but that there was a long way to go if an MDR extension was to be avoided. It wasn't avoided, and the extension that followed was conditional.
What it means now
The extension bought time. It did not lower the bar. Three points for manufacturers still working through the transition:
- The 2027 and 2028 dates are end dates, not starting lines. The conditions had to be met in 2024. If your legacy devices rely on the extension, your notified body has to finish its conformity assessment and issue MDR certificates before 31 December 2027 or 31 December 2028, depending on the device. Notified body schedules fill well ahead of those dates.
- Orphan devices now have guidance. The concern we raised in 2023 was answered in part by MDCG 2024-10 on clinical evaluation of orphan medical devices (June 2024).
- Don't plan around the pending revision. The December 2025 proposal could simplify parts of the MDR, but it is still moving through the legislative process. Until it is adopted and in force, the current MDR and the 2023/607 deadlines apply.
If you have legacy devices still on directive certificates, or you are not sure your transition plan holds up, our regulatory affairs team can help you pressure-test it. Talk with us.
Original sources (2023): European Commission press release and Questions and Answers, 6 January 2023.