The European Union’s medical technology rulebook — the Medical Device Regulation (MDR) and the In Vitro Diagnostic Regulation (IVDR) — is the most demanding device framework in the world, and its staggered transition deadlines now run to the end of the decade. For manufacturers placing products on the European market, 2026 is a pivotal year: the first hard deadlines bite and EUDAMED registration becomes mandatory.
Two regulations, one framework
Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) replaced the older directives with a far more rigorous regime. The headline changes are consistent across both: many products have been reclassified into higher-risk categories, clinical and performance evidence requirements are significantly stronger, notified body scrutiny is deeper, unique device identification (UDI) is mandatory, and post-market surveillance runs across the entire product lifecycle.
Transition deadlines that matter
Amending regulations extended the original timelines to ease the notified body bottleneck, creating a staggered set of deadlines. Under the MDR, as amended by Regulation (EU) 2023/607:
- Class III custom-made implantable devices — 26 May 2026;
- Class III and Class IIb implantable devices — 31 December 2027;
- other Class IIb, Class IIa, and Class I sterile or measuring devices — 31 December 2028.
Under the IVDR, as amended by Regulation (EU) 2022/112:
- Class D (highest risk, e.g. HIV or hepatitis tests) — December 2027;
- Class C (e.g. many cancer tests) — December 2028;
- Class B and Class A sterile devices — December 2029.
EUDAMED becomes mandatory
The European Database on Medical Devices (EUDAMED) is moving from voluntary to compulsory use. Mandatory use is now tied to the readiness of each individual module rather than being switched on all at once, and legacy devices are expected to be registered by 27 November 2026. Manufacturers, authorised representatives and importers should confirm their actor registration and prepare UDI and device data well ahead of that date.
Building a compliant pathway
- Confirm classification early — it determines the conformity route, the evidence needed and the deadline that applies.
- Secure notified body capacity — still the single biggest constraint; engage early.
- Strengthen clinical and performance evaluation, with a robust post-market surveillance and PMCF/PMPF plan.
- Align the quality system to ISO 13485 and risk management to ISO 14971, with technical documentation structured to Annexes II and III.
How PQRA helps
PQRA supports medical device and IVD manufacturers with regulatory strategy, device classification, technical documentation, quality management systems, notified body liaison and EUDAMED registration — helping you meet the right deadline with a defensible, inspection-ready file. Whether you are transitioning legacy devices or launching a new product, we build a compliance roadmap tailored to your portfolio.
Contact PQRA to plan your MDR or IVDR pathway.
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