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 ↗Free MDR Classification Tool
Determine your device class and required conformity assessment route in under 5 minutes.
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