Inadequate oversight led to unsafe medical devices on EU market.
CE marking via Notified Body; EUDAMED registration; UDI labelling; clinical evaluation; post-market surveillance
Withdrawal from market; fines up to €10M; criminal prosecution
Mandatory Deadline: Fully applicable May 2021 (Class III/IIb); Class IIa/I by May 2026
Affected HS Codes: 9018, 9019, 9020, 9021, 9022
Issuing Authority: European Commission / EMA