The EU MDR transition runs on a staggered schedule through 2028. Regulation (EU) 2023/607 and Regulation (EU) 2024/1860 extended the original deadlines after Notified Body capacity proved insufficient to process the volume of certification applications. Manufacturers must know exactly which deadline applies to their device class.
Why the deadlines were extended
The original MDR transition period ended May 26, 2024 for all legacy devices. Three factors made that timeline unworkable:
- Notified Body capacity: The number of designated MDR Notified Bodies remained insufficient to process applications from the estimated 25,000+ manufacturers needing recertification
- Technical complexity: MDR requirements, particularly clinical evaluation and post-market surveillance, demanded significantly more documentation than the legacy MDD/AIMDD directives
- Device shortage risk: Without extensions, thousands of established medical devices would have lost their legal basis for EU market access
The European Commission responded with two amending regulations that created class-based staggered deadlines while maintaining safety conditions for continued market access.
Complete deadline timeline
| Date | Requirement | Affected devices |
|---|---|---|
| May 26, 2026 | MDR QMS certificate required | Class III custom-made implantable devices |
| May 28, 2026 | EUDAMED mandatory for new devices | All new MDR/IVDR devices placed on market |
| November 28, 2026 | EUDAMED registration for legacy devices | All devices already on the market |
| May 28, 2027 | EUDAMED clinical investigation and vigilance modules mandatory | All manufacturers |
| December 31, 2027 | Transition ends | Class III and implantable Class IIb legacy devices |
| December 31, 2028 | Transition ends | All other Class IIb, Class IIa, Class Is/Im, and up-classified Class I legacy devices |
Conditions for continued market access during transition
Legacy devices may remain on the market past May 2024 only if all of the following conditions are met (MDR Article 120, as amended):
- The device was lawfully placed on the EU market before May 26, 2021 (or before the applicable date of the relevant IVDR provisions) under the prior directives
- The device continues to comply with the applicable directive (MDD 93/42/EEC, AIMDD 90/385/EEC, or IVDD 98/79/EC)
- There are no significant changes in the device's design or intended purpose
- The manufacturer has submitted an application to a Notified Body for MDR conformity assessment before the relevant deadline
- Post-market surveillance, vigilance, and market surveillance obligations under MDR already apply
A "significant change" includes any modification that could affect the device's conformity with the essential requirements of the applicable directive, its intended purpose, or its risk-benefit profile. If in doubt, consult your Notified Body.
The Notified Body bottleneck
As of early 2026, the average time for a successful MDR certification review is 13 to 18 months. This creates an urgent problem for manufacturers whose transition deadlines fall in 2027 or 2028.
| Deadline | Time remaining | Minimum NB review time | Latest safe application date |
|---|---|---|---|
| December 31, 2027 | ~20 months | 13-18 months | Q2 2026 |
| December 31, 2028 | ~32 months | 13-18 months | Q2 2027 |
Manufacturers who have not yet submitted applications to a Notified Body for Class III or implantable Class IIb devices face a real risk of missing the December 2027 deadline.
The European Commission has proposed a draft Implementing Regulation to standardize Notified Body procedures, including maximum timelines for quotations and reviews. However, this regulation has not yet been adopted.
What manufacturers should do now
If your transition deadline is December 31, 2027 (Class III, implantable Class IIb):
- Your application to a Notified Body should already be submitted or imminent
- If you do not yet have an application in progress, contact multiple Notified Bodies immediately to assess availability
- Begin compiling your MDR technical documentation now, prioritizing clinical evaluation and post-market surveillance plans
If your transition deadline is December 31, 2028 (Class IIa, other Class IIb, Class Is/Im):
- Submit your Notified Body application no later than Q2 2027
- Use the additional time to close gaps in clinical data and post-market surveillance
- Monitor Notified Body capacity and consider engaging earlier if slots are limited
For all manufacturers:
- Complete EUDAMED actor registration immediately (May 28, 2026 deadline for new devices)
- Register legacy devices in EUDAMED by November 28, 2026
- Ensure vigilance reporting complies with MDR requirements (already mandatory)
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Key takeaways
- The MDR transition uses staggered deadlines: May 2026 (custom Class III), December 2027 (Class III and implantable IIb), December 2028 (all others)
- Continued market access requires an active Notified Body application and full compliance with the applicable legacy directive
- Notified Body review takes 13 to 18 months on average, making early application essential
- EUDAMED becomes mandatory May 28, 2026 for new devices, November 28, 2026 for legacy devices
- Significant design or purpose changes during the transition disqualify a device from extended deadlines
- Manufacturers with 2027 deadlines who have not yet applied to a Notified Body face real risk of market withdrawal
How RegAid helps
RegAid covers the full MDR transition framework including Regulation (EU) 2023/607 and Regulation (EU) 2024/1860, with all relevant MDCG guidance documents on transitional provisions. Ask "What conditions must my Class IIb implantable device meet to stay on the market until December 2027?" and get a cited answer with links to the exact amended articles.