| 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.