What is the MDR?

The Medical Device Regulation (MDR), Regulation (EU) 2017/745, governs medical devices in the European Union. It entered into force in 2017 and has generally applied since 26 May 2021. Certain legacy products have transitional provisions with specific conditions.

The MDR addresses safety and performance, clinical evaluation, technical documentation and post-market surveillance. In-vitro diagnostics generally fall under the separate Regulation (EU) 2017/746 (IVDR). Germany's Medical Device Law Implementation Act supplements the European framework.

How do risk classes and market access work?

Classes I, IIa, IIb and III follow the relevant classification rules and intended purpose. Higher classes generally involve greater Notified Body participation. Certain Class I devices also have particular requirements.

Devices undergo conformity assessment and bear CE marking when the requirements are met. This differs from a medicine's marketing authorization. For medicine-device combinations, the regulatory route depends on the particular configuration and principal mode of action.

Which evidence and continuing duties matter?

Manufacturers need support for the safety and performance they claim. Clinical evaluation and risk management continue through the product lifecycle. Post-market surveillance collects experience and supports responses to risks; it does not mean that risks cannot occur.

Unique Device Identification supports traceability for many products. Documentation, labeling and actual product characteristics need to agree. New promotional claims may require assessment of whether existing evidence supports them.

What do EUDAMED and intended purpose mean for marketers?

The first four EUDAMED modules became mandatory on 28 May 2026: actor registration, UDI/device registration, Notified Bodies and certificates, and market surveillance. Particular duties and transitions follow the applicable requirements. The European Commission's EUDAMED overview explains implementation status.

Promotional statements particularly need to fit intended purpose and demonstrated performance. Article 7 MDR prohibits specified misleading claims. CE marking therefore does not authorize additional uses, unsupported superiority claims or omission of relevant risks.

Conclusion: Keep evidence and claims consistent

The MDR connects market access with continuing product responsibilities. Marketing, sales and Regulatory Affairs should use a consistent version of intended purpose, evidence and product documentation. This helps avoid misleading descriptions of authorization, certification and performance.