EU Medical Device Regulation

Lack of stringent oversight led to unsafe medical devices on the EU market.

Key Obligations

CE marking, clinical evaluation, post-market surveillance, EUDAMED registration, UDI

Penalty Ranges

Market withdrawal; criminal liability for serious non-compliance

Mandatory Deadline: 2021-05-26

Affected HS Codes: 90 (medical instruments and apparatus)

Issuing Authority: European Commission / EMA