PMS and PSUR Requirements Under the European MDR

Medical device post-market surveillance (PMS) activities were described in the European Medical Device Directive (93/42/EEC) and are part of the Quality Management System (QMS) certification under EN ISO 13485:2016. However, after various scandals such as PIP implants, PMS activities and oversight powers of Notified Bodies (NB) and Competent Authorities (CA) have been reinforced in the Medical Devices Regulation (MDR).
These PMS requirements even applied to manufacturers of legacy devices.

This whitepaper presents the MDR PMS obligations and considerations for implementation in a global QMS. You will learn:

• The purpose of key PMS documents, including the PMS plan, PMS report (PMSR), and Periodic Safety Update Report (PSUR);
• PMS inputs and outputs, and their impact on QMS records;
• An overview of PMSR and PSUR requirements.