Every requirement of Annex I answered with the method of demonstration and a reference to the document that carries it.
Clinical evidence
From 510(k) to MDR: which parts of the submission survive the move
The sentence we hear most often is that the device is already cleared, so the clinical work is done. Substantial equivalence to a predicate and equivalence under Article 61(3) MDR are different tests, applied by different people, for a different purpose.
What equivalence means in the Regulation
Under Article 61(3)(a) MDR, literature relating to another device can support a clinical evaluation only where the device under evaluation is demonstrated to be equivalent to it in accordance with Section 3 of Annex XIV, which sets the test on technical, biological and clinical characteristics. For implantable and class III devices there is a further condition that regularly ends the discussion. Article 61(5) allows a manufacturer to avoid a clinical investigation by relying on a device it did not make only where the two manufacturers have a contract explicitly allowing full access to the technical documentation on an ongoing basis, and the original clinical evaluation was performed in compliance with the Regulation.
A 510(k) predicate is chosen from the public record and needs no such contract. That is why a predicate comparison, however well argued, is not portable. It answers a question about market history, not about clinical evidence.
What is reusable and what has to be produced
| From the US submission | Use in the EU file |
|---|---|
| Bench and performance testing | Reusable where the standard edition matches the one cited for the Union |
| Biocompatibility testing | Reusable, usually with additional chemical characterisation and a toxicological risk assessment |
| Animal studies and usability engineering | Reusable as clinical evaluation inputs |
| Software documentation | Reusable, restructured against IEC 62304 and the EU expectations on cybersecurity |
| Clinical study data held by the manufacturer | Reusable, appraised under the methodology of the clinical evaluation |
| Predicate comparison | Not reusable as a demonstration of equivalence |
| Labelling and instructions | Rebuilt against Annex I Chapter III |
| Risk file | Reusable, aligned to ISO 14971 and mapped to the general safety and performance requirements |
What has to exist before a notified body will progress the file
A stated development stage, a defined literature methodology, an appraisal of each data set and a conclusion the evidence can carry.
Post-market clinical follow-up under Annex XIV Part B, or a justification for its absence that a reviewer can accept.
Article 84 and Annex III, feeding the periodic safety update report for class IIa and above.
For implantable and class III devices under Article 32, written for the intended audience and validated by the notified body.
The transitional dates still shape the plan
For devices moving from the old directives, the transitional provisions in Article 120 run to 31 December 2027 for class III devices and implantable class IIb devices other than the listed exceptions, and to 31 December 2028 for other class IIb devices, class IIa devices and class I devices placed on the market in sterile condition or with a measuring function. Those extensions are conditional, and one of the conditions was a notified body application made by 26 May 2024.
A manufacturer entering the market now with a new device does not sit inside those transitions at all. It goes straight to the MDR route, which is why the honest planning question is not how fast a certificate can be obtained, but which notified body has capacity in the relevant code and what the file has to look like before an application is worth making.
Questions from regulatory affairs teams
Can we use published literature on similar devices instead of our own data?
Literature on similar devices supports the state of the art and the risk analysis. It does not replace clinical data on your device unless equivalence is demonstrated under Section 3 of Annex XIV.
Our device is class II in the US. What is it in Europe?
That has to be classified under Annex VIII, and the answer is often a different class. Classification changes the conformity route, the notified body scope and the cost, so it is settled first.
Do we need a clinical investigation?
For implantable and class III devices, Article 61(4) sets that as the starting point, with defined exemptions. For other classes it depends on what the existing evidence can carry.
When should the authorised representative be appointed?
Before the declaration of conformity is signed. The representative verifies the declaration and the technical documentation, and it is the party through which the manufacturer is registered in the Union.
Official basis checked on 15 August 2026
The MDR provisions cited on this page were checked against the official EUR-Lex text.
Regulation (EU) 2017/745 (MDR) in EUR-Lex →
Plan the EU route
Map the work before committing to a certification timeline.
Use the US-to-EU hub to separate reusable evidence from European work, or review the wider service scope for manufacturers established outside the Union.