Under the European IVD and medical device directives, once a Manufacturer has CE marked their device and placed it on the market they still have to meet certain obligations. Implementation of a system for post-market surveillance is a requirement for all classes of IVDs and medical devices, but what is post market surveillance, and what does this mean in practice?
Post-market surveillance is the collection of information on quality, safety and performance of medical devices after they have been placed on the market. It provides on-going feedback to help maintain quality, device safety and customer satisfaction. As product risks can never be completely eliminated, manufacturers need to continually monitor feedback through post-market surveillance to ensure risk is maintained at an acceptable level.
Examples of post-market surveillance activities include: clinical literature searches, search of adverse events and field actions for similar products (e.g. use of FDA MAUDE / Recall databases, HPRA or MHRA listings of Field Safety Notices), Health Care Professional questionnaires; analysis and trending of internal processes i.e. CAPA, complaints, non-conformances, servicing issues; adverse event reports.
A formal post-market surveillance review is necessary to understand how the device is performing in real life situations. Typically a post-market surveillance review meeting may be held 1 year after the device has been launched (or undergone a significant design change). Product-related data from the various sources is analysed and reviewed by a cross-functional team. Actual or potential safety and performance issues are reviewed, and any necessary actions for improvement or mitigation are agreed upon. A post-market surveillance review frequency can typically be set at a frequency of up to 3 years, however, products which pose a higher risk or have significant product safety or quality issues should be formally reviewed more frequently. From a safety perspective, the product benefits must continue to outweigh the risks throughout the lifecycle of the product.
If you are unsure of the requirements or need support in setting up your post-market surveillance process, contact us here at Acorn Regulatory. We’ll be glad to help.
[ninja_form id=1]
