The EU Medical Device Regulation (MDR 2017/745) became applicable on 26 May 2021. Because of limited notified body capacity, the EU extended the transition periods significantly in March 2023 through Regulation (EU) 2023/607.
Which deadline applies?
| Device group | Latest validity of MDD certificate |
|---|---|
| Class III devices | 31 December 2027 |
| Implantable Class IIb devices (except those below) | 31 December 2027 |
| Other Class IIb devices | 31 December 2028 |
| Class IIa devices | 31 December 2028 |
| Sterile or measuring Class I devices | 31 December 2028 |
| Devices that were Class I under MDD and require a notified body under MDR | 31 December 2028 |
Implantable IIb exceptions: sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors fall under the 2028 deadline.
Conditions for the extension
The extension is not automatic. All of the following must be met:
- The device continues to comply with the MDD.
- There are no significant changes in design or intended purpose.
- The device does not present an unacceptable risk to health or safety.
- By 26 May 2024: the manufacturer had a QMS in place in accordance with MDR Article 10(9).
- By 26 May 2024: the manufacturer had lodged a formal MDR application with a notified body.
- By 26 September 2024: the notified body and manufacturer had signed a written agreement.
Manufacturers who missed the 2024 milestones can generally only place the device on the market again once an MDR certificate has been issued.
MDR obligations that already apply
Even legacy devices are subject to MDR requirements on post-market surveillance, vigilance, market surveillance and registration. A common audit finding is a PMS plan still based on MDD-era templates.
Recommended roadmap
- Portfolio review: re-classify each product family under the MDR and flag up-classified products. Our MDR classification tool helps with a first pass.
- Commercial prioritisation: decide which products are worth transitioning.
- Gap analysis: review technical documentation against MDR Annexes II and III. GSPR, clinical evaluation and PMS documents usually show the largest gaps.
- Clinical evidence strategy: assess whether existing clinical data meets the MDR’s “sufficient clinical evidence” expectation. Equivalence claims are much harder under the MDR.
- Notified body planning: review times are long, so align your submission calendar early.
- Change control: assess and record every change against the “significant change” criteria.
Regulation keeps moving
Work on revising the MDR to improve its workability is ongoing in the EU, and future amendments may affect these deadlines or conditions. We update this guide regularly. Always confirm your plans with your notified body and the current official texts.
See our CE/MDR service to plan your transition with us.
FAQ
Our MDD certificate has expired. Can we still sell the device?
If your certificate expired after 20 March 2023 and you met the conditions of Regulation 2023/607 in time (MDR-compliant QMS, application to a notified body and a signed agreement), it may be deemed valid until 31 December 2027 for Class III and implantable Class IIb, or 31 December 2028 for other devices. Document this with a confirmation letter from your notified body.
Which MDR requirements apply during the transition?
Even for legacy MDD-certified devices, MDR requirements on post-market surveillance, market surveillance, vigilance and registration of economic operators and devices apply (MDR Article 120(3)).
Can we change the device during the transition?
No significant changes in design or intended purpose are allowed for devices relying on the transition. Use MDCG 2020-3 to assess whether a change is significant and document your assessment.