From May 2021 with the entry into force of the new MDR 2017/745, all manufacturers of Class IIa, IIb and III medical devices will be required to prepare an updated periodic safety report “PSUR” for each product or product family. (Art 86 of the MDR).
For this reason, PSUR Report becomes a regulatory requirement for all medical devices, even if they are still CE marked under the previous MDD 93/42/EEC, this report will be reviewed by the notified bodies during the annual CE marking follow-up audits to manufacturers.
Its periodicity depends on the type of product:
Class IIa products
Every two years
Class IIb products Anually
Class III products Anually
Azierta, a leading Life Sciences consulting firm, assists manufacturers in the preparation of PSUR reports, since we have a team of professionals with extensive experience in Medical Devices,