Post-Market Surveillance of Devices

The Post-Market Surveillance (PMS) system is an essential process for ensuring the safety and effectiveness of medical devices placed on the market.

Integrated into the manufacturer’s quality management system, PMS is based on Articles 10.10 of Regulation (EU) 2017/745 (MDR) and 10.9 of Regulation (EU) 2017/746 (IVDR).

This process has been significantly strengthened since the MDR and IVDR came into force, introducing more regulations and requirements for manufacturers and increased oversight by competent authorities and Notified Bodies (NBs).