PMS & PSUR requirements under the EU MDR
Medical device post-market surveillance (PMS) activities have already been 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, resulting from various scandals such as PIP implants, PMS activities and oversight powers of Notified Bodies (NB) and Competent Authorities (CA) have been reinforced.
Consequently, on May 26th, 2021, the Medical Devices Regulation (MDR) will impose new PMS requirements and supplemental reporting to NBs or CAs in proportion to the risk class and the type of device. This whitepaper presents the new MDR requirements regarding PMS obligations and the risks resulting from their 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;
- and more.
Download this 9-page white paper to learn more about changing PMS requirements under the EU MDR.
About the author:
Alexandre Pétiard is a Senior Regulatory and Quality Consultant at Emergo by UL. With more than 10 years of experience in regulatory affairs, his expertise includes design control support, technical file preparation, clinical evaluation report, risk management file, 510(k), quality system implementation and audits, and post-market surveillance and vigilance activities. Mr. Pétiard previously held regulatory positions at Covidien, Integra LifeSciences, and Alcis.
This whitepaper presents the new MDR requirements regarding PMS obligations and the risks resulting from their implementation in a global QMS.