BSI — MDR Transition Guide for Medical Device Manufacturers
Summary
BSI Group’s comprehensive guide covering the transition from MDD (93/42/EEC) to the EU MDR (2017/745), including timelines, key changes, and practical steps for manufacturers. Covers conformity assessment procedures, Notified Body expectations, and technical documentation requirements.
Document Details
Document IDBSI-MDR-TRANSITION
TypeNB White Paper
AuthorityBSI Group (NB 2797)
Publication Date2023-01-01