EU MDR 2017/745

Plain-language guides to EU Medical Device Regulation 2017/745 — from classification through technical documentation, clinical evaluation, and post-market surveillance.

EU 2017/745 — EUR-Lex ↗

What is the EU MDR and who must comply?

For: Everyone new to MDR

How are medical devices classified under MDR?

For: All manufacturers

What is a Notified Body and when do I need one?

For: Class I* / IIa / IIb / III

What technical documentation does MDR require?

For: RA engineers, QA teams

What does clinical evaluation under MDR require?

For: RA, clinical affairs

What are the MDR post-market surveillance requirements?

For: All manufacturers

How does MDR treat Software as a Medical Device (SaMD)?

For: Software teams, SaMD

How does EU MDR compare to FDA regulations?

For: Companies targeting both markets

What is MDR 2.0 and what will change?

For: All manufacturers

How do I transition from MDD to MDR?

For: Legacy device manufacturers

What does an MDR audit check?

For: QA teams, RA engineers

How does UDI and EUDAMED work?

For: All manufacturers