Post-Market Surveillance

Medical device post-market surveillance (PMS) activities are 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 concerns surrounding PIP implants, PMS activities and oversight powers of Notified Bodies (NB) and Competent Authorities (CA) have been reinforced. Therefore, consequently, on May 26th, 2020, 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.