EU MDR News!! (PSUR Guidance)
MDCG 2022- 2021 GUIDANCE ON PERIODIC SAFETY UPDATE REPORT (PSUR) ACCORDING TO REGULATION (EU) 2017/745 (MDR) December 2022.
This guidance is applicable to medical devices which have been certified under the MDR and to devices which have been certified under MDD 93/42/EEC or AIMDD 90/385/EEC except for devices which have stopped being placed on the EU market before the MDR date of entry into application (DoA) (see section 3.1). It does not apply to in vitro diagnostic medical devices which have been certified under IVDR (EU) 2017/746 or IVDD 98/79/EEC for which a specific guidance is intended.
Manufacturers of class I devices do not have to prepare a PSUR; instead, they should prepare a Post-Market Surveillance Report (PMSR) as detailed in Article 85. This guidance, although not covering PMSR, may provide useful suggestions on how information can be presented