Theme PSUR – Article 86 MDR
Target Audience Manufacturers of class IIa, IIb, and III medical devices
Products concerned MD
Regulatory reference

MDR (EU) 2017/745

Documents mentioned MDCG 2022-14
MDCG 2021-25
MDCG 2021-3
MDCG 2021-1 rev.1
IMDRF Adverse Event Terminology (IMDRF/AE WG/N43FINAL:2020 Edition 4)

The main objective of this guidance document is to help manufacturers implement the legal requirements set out in Article 86 of the MDR.

As a reminder, manufacturers of class IIa, IIb and III DM must draw up a report summarising and concluding the analysis of PMS data collected as part of the risk assessment procedure.