One of the important requirements of the medical device regulations is the documentation and maintenance of a systematic procedure to document performance and safety of medical devices once in the market. The requirements and the need for implementation of post-market surveillance system is outlined in various standards and regulations including EU MDR, MDD, MEDDEV, ISO 13485, ISO 14971 and US FDA among other guidelines.
Post-market surveillance work has usually been dismissed by medical device makers. However, regulatory bodies globally areto implement additional rigorous needs for post-market surveillance workrequiring medical devicemanufacturers to take action to stay compliant.Regulatory bodies areencouraging manufacturers to take up proactive approaches instead of relying solely on reactive systems, like complaints observation.
Post market surveillance as defined by EU regulations is to proactively collect and review experience gained from devices placed on the market. This system helps to systematically identify risks associated with devices during practical usage. This data from PMS can be used to constantly update the benefit risk assessment. Peter J. Ogrodnik in his book ‘Medical Device Design’ recommends having a three-pronged approach to developing the post market surveillance system. The three prongs include clinical literature and knowledge base, sales data and lastly quality related material from technical knowledge base.
Two common terms associated with PMS are post market clinical follow-up and vigilance.
Post-Market Clinical Follow-Up (PMCF)
As per EU regulations, PMCF is the systematic collection of clinical data to answer important questions regarding safety or performance of medical devices for which sufficient clinical evidence is not available. Under MDR, PMCF is considered to be part of PMS.
MEDDEV 2.12/2 Rev. 2 is the guideline from EU which was created with the intention to supply information to conduct post-market clinical follow-up (PMCF) studies.
Vigilance
Vigilance is a reporting system that is used to report incidents rising with the use of the device. There is a MEDDEV guideline on medical device vigilance system MEDDEV 2.12-1 Rev. 8.