What are the requirements of Post Market Surveillance under MDR (2017/745)?
Under MDR, PMS contains both proactive and reactive elements and the Medical Device and manufacturers need to consider the following activities –- Post Market Surveillance
- Risk Management
- Clinical Evaluation Plan and report
- Post-market surveillance plan and report
- Post-market clinical follow up (PMCF) plan and evaluation report
- 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.What are the impacts to 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. Since the timeline for implementation is fast approaching (May 2020), manufacturers need to assemble resources and systems to perform the additional required tasks to satisfy MDR 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