BSI — Post-Market Surveillance and Vigilance Under EU MDR
Summary
BSI guide explaining post-market surveillance requirements under EU MDR, including PMS plans, Periodic Safety Update Reports (PSUR), trend reporting, and vigilance obligations. Covers MDR Articles 83-92 and practical implementation guidance.
Document Details
Document IDBSI-PMS-VIGILANCE
TypeWhite Paper
AuthorityBSI Group (NB 2797)
Publication Date2023-11-01