EU Medical Device Regulation (MDR) 2017/745

Inadequate oversight led to unsafe medical devices on the EU market.

Key Obligations

["CE marking mandatory for all medical devices", "Unique Device Identifier (UDI) on all devices", "Clinical evaluation documentation required"]

Penalty Ranges

Up to €500,000 or 10% annual turnover

Affected HS Codes: ["9018", "9019", "9020", "9021", "9022"]

Issuing Authority: European Commission