EU-MDR — Blog

EU-MDR

3 articles

2026-05-11

MDD to MDR Transition Guide & Compliance Checklist (2026)

Downloadable MDD to MDR transition checklist. Extension deadlines under Regulation 2023/607, Notified Body capacity, technical documentation & QMS gaps.

EU-MDRMDDREGULATORY-COMPLIANCECE-MARKINGTRANSITION

2026-05-05

EU MDR vs MDD: 12 Key Changes Every Device Manufacturer Must Know (2026)

Side-by-side comparison of MDD vs EU MDR — clinical evidence, UDI, EUDAMED, PMS, and reclassification rules. Includes compliance checklist and transition deadlines.

EU-MDRMDDEUDAMEDCE-MARKINGREGULATORY-COMPLIANCE

2026-05-05

EUDAMED Guide 2026: Mandatory Modules, Deadlines & Registration

EUDAMED first four modules became mandatory on 28 May 2026. Actor SRN, UDI/devices, certificates, market surveillance — plus legacy registration by 28 Nov 2026 and what still is not live.

EUDAMEDEU-MDRDATABASEMEDICAL-DEVICESREGULATORY-COMPLIANCEUDISRN