Requirements of Post Market Surveillance under MDR (2017/745), Article 83
Under MDR 2017/745, Article 83, manufacturers shall consider the risk class of the particular device and base their PMS system around that. PMS contains both proactive and reactive elements which include:- Post Market Surveillance Plan
- Post Market Surveillance Report
- Post Market Clinical Follow Up
- Periodic Safety Update report (PSUR)
- Summary of Safety and Clinical Performance (SSCP)
- Vigilance
Integration into Quality Management System (QMS)
Manufacturers are required to incorporate PMS activities into their Quality Management System (QMS) – and these activities need to link with many elements of the QMS, including Design and Development, Management Review, etc. It is also important to note the Post Market Surveillance, Risk Management and Clinical Evaluation all feed into each other.How does this impact Medical Device manufacturers?
There are many impacts to manufacturers, who in the past may have relied on their complaint and feedback systems to satisfy post market surveillance requirements. These now include:- requirements for resources for performing the collection and evaluation of data, and writing of reports
- the requirement for resources to perform documentation updates (risk, clinical evaluation, technical documentation)
- consideration of the impact on other economic operators