Background on post-market surveillance globally
PMS has been a pivotal topic. The European regulations (Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR)) officially defined the term PMS (Article 2(60)). In 2019, the U.S. FDA introduced the term Total Product Life Cycle (TPLC) as a "holistic” perspective with the FDA throughout the entire lifecycle of the device.
In 2020, ISO released ISO/Technical Report (TR) 20416:2020 on PMS which was published as a guide to assist manufacturers.
Post-market Surveillance Continues to Have Tremendous Interest (emergobyul.com)
Post-market Surveillance Continues to Have Tremendous Interest
The Dutch authorities have published the report of their activities related to post-market surveillance (PMS).
www.emergobyul.com
