May 9, 2022
Medical device makers perform post-market surveillance efforts to gather and assess data from products that have been on the market, and to determine if any action is necessary. Post-market surveillance is an essential tool to verify that medical devices remain safe and effective, and to guarantee that appropriate action is taken if the danger of continuing use of the medical device outweighs the benefit. Medical devices can benefit from a review of their post-market surveillance experiences.
The Medical Device Safety & Regulations Compliance Summit by GlobalBSG and their economic operators is discussed in this article together with market surveillance by regulators and the involvement of other stakeholders throughout these processes as a whole. Measures implemented to keep medical devices compliant with the standards for safety, quality, and performance after they have been put on the market are described.
What is Post-Market Surveillance for Medical Devices?
According to GlobalBSG, pharmacovigilance, or the study of the safety of drugs and medical devices, includes post-market monitoring, or PMS, of medical devices. Pre-market surveillance (PMS) is a vital element of a device’s lifetime since it gives more data and information than the clinical trial period. It provides a full view of a device’s safety and efficacy by using data from the field.
This allows manufacturers to construct a thorough risk/benefit profile for their product and quickly rectify any concerns that may occur throughout the device’s lifespan. As part of their PMS, manufacturers also gather information about competing products.
Both internal vigilance (by manufacturer-established internal databases that collect post-market customer complaints and failure analysis or adverse event reports) and external vigilance by country-specific regulatory authorities can collect these data as part of a vigilance analysis. It is common practice to compare internal surveillance data with device sales to determine the best risk/benefit ratio. One of the first rules to establish expectations for reassessing estimated risk ratios throughout the development of a device with real-world vigilance and sales data in the post-market phase of EU-MDR is a good example of this approach.
Off-label usage in demographics and indications for which the device is not designed can be detected by systematic and periodic literature searches and continuous monitoring for manufacturers’ and competitors’ products through publication alerts.
Post-Market Surveillance Regulatory Landscape Changes
The now-defunct Global Harmonisation Task Force (GHTF), a voluntary gathering of members from medical device regulatory agencies and the regulated sector, explored post-market surveillance in 2005.
Post-market monitoring in the sector was outlined in a study by the GHTF, which explored how regulatory criteria for each activity might be standardised. A revised version of this document, prepared by the International Medical Device Regulators Forum (IMDRF), provides more information on how adverse event reports should be sent.
A lack of precise advice on post-market surveillance in Europe’s Medical Device Directive (MDD) was remedied by its successor. Regulation 2017/746 (MDR) defines PMS as:
- All activities carried out by manufacturers or other economic operators to establish and maintain a systematic procedure to collect and review experience gained from devices they place on the market, make available, or put into service to determine whether any necessary corrective or preventive actions need to be implemented immediately.
- When a high-risk device has been awarded 510(k) clearance or PMA approval, the term PMS is used specifically to allow the US FDA the ability to force manufacturers to conduct studies of those devices that have been approved.
- TPLC (Total Product Life Cycle) and IDEAL (Intelligent Design for a Lifetime) are two recent programmes to gather and evaluate data on medical devices (Idea, Development, Exploration, Assessment, and Long-Term Study). The FDA’s computerised MDR system receives information from producers, importers, and end-user institutions.
- Regardless of how a medical device is categorised, all conformity assessment standards, including ISO 13485:2016, now require manufacturers to maintain a PMS system.
Conclusion
Healthcare organisations and regulators are increasingly concentrating their efforts on monitoring and mitigating medical device safety & regulations compliance post-market risks. Standards in the United States and Europe are fast converging and it’s necessary to set up a PMS system to ensure that your product may be sold throughout the world.
It’s also a good idea to keep an eye on things after the Medical Device Safety & Regulations Compliance Summit. Effective PMS strategies with GlobalBSG let you know about potential defects in the design or execution of your product, demonstrating your company’s dedication to the end-user and allowing for continual improvements and outcomes to be achieved over time.
