Post-Market Surveillance System for Medical Devices

With the entry into force of the new regulations on medical devices (MDR 745/2017) and in vitro diagnostic medical devices (IVDR 746/2017), new requirements have raised questions among manufacturers of medical devices and in vitro diagnostic medical devices regarding post-market surveillance, both for their safety and effectiveness (Post Market Surveillance – PMS) and for their post-market clinical follow-up and Vigilance.

Once products are placed on the market for use, manufacturers are required to collect data on their performance, and EU countries will act with greater coordination in the field of market surveillance.

While continuous process evaluation and improvement is at the heart of this change, the regulations establish more decisive and normative measures based on the product's risk level, for both the MDR and the IVDR.

What NOVITAS for you:

• Development and installation of a product surveillance system for the post-market phase (PMS plan).
• Development and installation of a post-market clinical follow-up system (PMCF)
• Development and installation of a vigilance system