EU Medical Devices Regulation (MDR) 2017/745

Inconsistent medical device safety standards across EU member states.

Key Obligations

["CE mark all medical devices", "Register in EUDAMED database", "Appoint EU Authorised Representative", "Post-market surveillance and vigilance reporting"]

Penalty Ranges

{"note": "Member state penalties; product recall and market withdrawal"}

Mandatory Deadline: 2021-05-26

Affected HS Codes: ["90"]

Issuing Authority: European Commission / Notified Bodies