Medical Device Post-Market Obligations – a European Perspective: Part 1 – Post-Market Surveillance
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.