What is MDR 2.0 and what will change?
EC legislative proposal December 2025 · Not yet in force as of April 2026
Status notice
The "MDR 2.0" proposal is a European Commission legislative proposal published in December 2025. As of April 2026, it has not been formally adopted. It requires co-decision by the European Parliament and Council before it has legal force. Do not make certification planning decisions based on proposed changes that have not yet been adopted.
The short answer
The European Commission published a legislative proposal in December 2025 to revise both MDR (2017/745) and IVDR (2017/746). The proposal aims to address practical challenges that emerged during MDR implementation — particularly around Notified Body capacity, lower-risk device burdens, and SaMD/AI classification clarity. It has not entered into force.
Key proposed changes
- Streamlined conformity assessment for lower-risk devices: Reduced documentation requirements for certain Class IIa devices; targeted relief for devices with long safety track records
- Adjusted transition timelines for legacy devices: Proposed extended transition windows for devices already undergoing MDD-to-MDR migration
- Clearer rules for SaMD and AI-enabled devices: Explicit provisions to reduce ambiguity in Rule 11 application; alignment with EU AI Act definitions
- Changes to Notified Body oversight: Proposals to address NB capacity constraints and improve consistency of NB decisions across member states
- EUDAMED simplification: Proposed refinements to EUDAMED registration requirements to reduce administrative burden
What is NOT changing
- Risk-based classification: The four-class system (I, IIa, IIb, III) and Annex VIII rules remain
- CE marking system: CE marking as the EU market access mechanism remains unchanged
- Clinical evaluation requirements: Annex XIV requirements remain; continuous CER process is maintained
- Technical documentation: Annex II/III structure and content requirements remain substantively unchanged
- Post-market surveillance: PSUR and PMS Report requirements remain
Current transition timelines (Regulation (EU) 2023/607)
These are the legally binding transition deadlines currently in force. Do not assume MDR 2.0 will change these deadlines until formal adoption occurs.
| Device class (under MDD) | MDR certificate required by | Conditions |
|---|---|---|
| Class IIb / Class III (MDD) | 31 May 2024 | Extended deadline under 2023/607; NB application required before 26 Sep 2024 |
| Class IIa / Class Is / Class Im (MDD) | 31 May 2026 | NB application required before 26 Sep 2024; no significant design change; continued availability |
| Class I legacy devices requiring new NB involvement | 31 May 2028 | Same conditions as above |
Frequently asked questions
When will MDR 2.0 take effect?
Unknown as of April 2026. The proposal must pass through European Parliament and Council co-decision procedures. This typically takes 12–36 months from proposal. A formal adoption announcement will include a date of entry into force.
Should I plan my certification for MDR 2.0 now?
No. Plan for MDR as currently in force. If MDR 2.0 is adopted and reduces requirements for your device, you can revise your plan at that point. Building a compliance program around proposed but unadopted legislation creates regulatory risk.
How can I monitor developments?
Monitor the European Commission's health technology legislation portal, MDCG guidance publications, and the Official Journal of the EU (EUR-Lex). Professional associations (EUCOMED, MedTech Europe) also publish regulatory updates.