|Theme||PSUR – Article 86 MDR|
|Target Audience||Manufacturers of class IIa, IIb, and III medical devices|
MDR (EU) 2017/745
|Documents mentioned||MDCG 2022-14
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.