Regulation (EU) 2017/745 on medical devices (MDR) has established specific requirements which focus on how manufacturers should establish and maintain a post market surveillance and vigilance system. This article examines how this will be implemented and sustained.
Under the MDD 93/42/EEC , manufacturers were required to comply with the requirements of PMS by having an up to date systematic procedure that was employed to review experience gained from devices in the post-production phase and to implement appropriate measures to apply any necessary corrective action.
However, under MDR 2017/745 the requirements for PMS and Post-market clinical follow-up activities are are now more complex. Therefore, manufacturers will need to maintain more robust Post Market Surveillance procedures and perform more post-market clinical follow-up studies to meet the new MDR requirements.
Article 2, section 60 of the MDR 2017/745 defines Post Market Surveillance as:
‘all activities carried out by manufacturers in cooperation with other economic operators to institute and keep up to date a systematic procedure to proactively collect and review experience gained from devices they place on the market, make available on the market or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions.’
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
Under MDR 2017/745 , Annex III Technical Documentation on Post Market Surveillance, the PMS and Periodic Safety report/Periodic Safety update report are required to be part of the Technical Documentation as specified in Annex II and III of MDR (2017/745) and, specific timelines regarding the update of the Periodic Safety Update Reports and their availability to Competent Authorities and Notified Bodies (depending on Classification of device) are detailed in the new MDR.
The increased requirements regarding Post-Market Clinical Follow-up (PMCF), requires additional planning by manufacturers to adequately cover these in their PMS System. A specific PMCF plan is required for describing the activities. Post-Market Clinical Follow-up is a continuous process that is part of clinical evaluation and links evidence collected in the premarket stage with Post Market data collected when the device is in regular use.
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
Note that the resources are not limited to Regulatory and may include Quality Assurance, Clinical affairs, Service, Sales and Marketing, Service and other Economic Operators.
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