The IVDR has applied since May 26, 2022, but because of limited notified body capacity, legacy devices certified or self-declared under the old directive have been given extra time. The rules continue to evolve.
Transition deadlines for legacy devices
Regulation (EU) 2024/1860 extended the transition periods. Legacy devices can stay on the market only if they continue to comply with the old directive, have no significant changes in design or intended purpose, and the manufacturer meets interim milestones:
| Device class | IVDR-compliant QMS | Apply to notified body | Signed agreement | End of transition |
|---|---|---|---|---|
| Class D and IVDD-certified | May 26, 2025 | May 26, 2025 | September 26, 2025 | December 31, 2027 |
| Class C | May 26, 2025 | May 26, 2026 | September 26, 2026 | December 31, 2028 |
| Class B and sterile Class A | May 26, 2025 | May 26, 2027 | September 26, 2027 | December 31, 2029 |
Missing an interim milestone ends the transition for that device. New devices, and legacy devices with significant changes, must comply with the IVDR in full.
In-house devices
Requirements for tests made and used within EU health institutions have been phased in since 2022, with the final condition, justification that no equivalent device on the market meets the patient group’s needs, applying from December 31, 2030.
The targeted revision
In December 2025 the European Commission proposed a targeted revision of the MDR and IVDR. Key themes include:
- Reducing administrative burden and making requirements more proportionate to risk
- More predictable and efficient notified body procedures, including structured dialogue
- Adjustments to some classification rules, including for certain software
- Digital documentation such as electronic instructions for use
- Pathways for breakthrough and orphan devices
- More flexibility for in-house devices made by health institutions
The European Parliament and Council are negotiating the proposal, and adoption is expected around 2027. Until then, the current rules and deadlines apply.
What to do now
- Keep transition plans on track; do not wait for the revision
- Confirm interim milestones are met for every legacy device
- Register devices in EUDAMED on time
- Monitor the legislative process and assess the impact on your portfolio
- Use the transition to strengthen performance evidence and PMS
IVDR guide
Overview · Scope and Key Definitions · Risk Classification · Conformity Assessment and Notified Bodies · Performance Evaluation · Technical Documentation · Post-Market Surveillance and Vigilance · Economic Operators, UDI and EUDAMED · Transition Deadlines and Reform
Need help? Salto Partners guides diagnostics, genomics and medical device companies through ISO 13485 and IVDR. Send us an email and we will set up a conversation.
For general information only; not legal or regulatory advice. Regulations and deadlines change, so confirm current requirements with your notified body or regulatory counsel. Last updated October 2026.