How do I transition from MDD to MDR — and what are the deadlines?
MDR 2017/745 · Regulation (EU) 2023/607 · Article 120 MDR
Important
All MDD certificates have now expired or are in extended transition under Regulation (EU) 2023/607. No new devices may be placed on the EU market under MDD certificates after the applicable deadline. MDR certificates are required for new placements on market.
Transition deadlines (Regulation 2023/607)
| Device class (MDD) | Extended deadline | Key conditions |
|---|---|---|
| Class IIb / Class III | 31 May 2024 | NB application submitted before 26 Sep 2024; no significant design change; device remains safe |
| Class IIa / Class Is / Class Im | 31 May 2026 | NB application submitted before 26 Sep 2024; no significant design change; continued availability condition |
| Class I legacy (new NB involvement required) | 31 May 2028 | Same conditions as Class IIa row |
Transition conditions under Regulation 2023/607
To benefit from the extended transition deadlines, all of the following conditions must be met:
- The device must continue to comply with MDD/AIMDD requirements and remain safe under the applicable MDD/AIMDD conformity criteria (per Art. 120 legacy-device transitional provisions)
- No significant changes have been made to the device's design or intended purpose since the MDD certificate was issued
- The manufacturer must have submitted a formal MDR certification application to a Notified Body before 26 September 2024
- The manufacturer must have a written agreement with a NB for the MDR conformity assessment
- The device must continue to be available to ensure uninterrupted patient access (the "continued availability" condition)
Key transition steps
- Gap analysis: Compare your existing MDD technical documentation against MDR Annex II/III requirements — identify what is missing or needs updating
- Update technical documentation: Restructure to Annex II/III format; update CER to MDR Annex XIV requirements; add PMCF plan
- Establish MDR PMS system: PMS plan, complaint handling, literature surveillance, PSUR/PMS Report cycle
- Appoint PRRC: Person Responsible for Regulatory Compliance per Article 15; documented qualifications required
- Update QMS: Ensure QMS covers all MDR-specific requirements (PRRC, EUDAMED, UDI, expanded PMS obligations)
- Register in EUDAMED: Actor registration, device registration, UDI registration
- File for MDR certificate: Submit complete technical documentation to Notified Body for Annex IX/X/XI conformity assessment
Frequently asked questions
What counts as a "significant change" that voids the transition?
A significant change is one that affects the safety or performance of the device or its intended purpose. MDCG 2020-3 provides guidance on assessing changes. New intended uses, significant design modifications, changes to materials in contact with patients, and software updates that affect clinical function are typically considered significant.
My MDD certificate expired but the device is still in the distribution chain — is that legal?
Devices that were lawfully placed on the market before the transition deadline can remain in distribution and continue to be used. However, no new units may be placed on the market after the applicable deadline without an MDR certificate. Distributors and importers should confirm the date of placement on market.
What are the distributor obligations during transition?
Distributors must verify that devices they make available still meet the applicable requirements. During the transition period, distributing MDD-compliant devices that were placed on market before the deadline remains lawful. After the deadline, only MDR-certified devices may be made available.