The term market surveillance covers the activities carried out by national regulatory authorities to ensure the safety and efficiency of products placed on the market. In these activities, the national regulatory authorities put measures in place to verify and guarantee the regulatory compliance of products and to establish processes and appropriate measures for diminishing [...]
It's not enough to make a device and put it on the market—you must know how people use your product. Therefore, the post-market surveillance must cover all devices that have been placed on the market, including devices that have been incorporated or are intended to be incorporated into a medical device system (i.e., active implantable [...]
In July 2021, Regulation (EU) 2019/1020 on market surveillance and product compliance, issued by the European Parliament and Council, came into force. The regulation forms the core of European market surveillance law and will grant market surveillance authorities additional powers and strengthen the exchange of information between competent authorities. Furthermore, it seeks to uniformly [...]
Post-market surveillance and vigilance costs are overgrowing. For example, the number of reported adverse reactions has increased annually by approximately 10-15% over the past five years. In addition, costs for post-market surveillance have been growing, especially in high-risk products. What is PMS or post-market surveillance? In post-market surveillance, a drug or medical device is [...]
Most regulatory staff can define post-market surveillance relatively succinctly. Perhaps also vigilance. But when it comes to market surveillance, what exactly makes it different from post-market surveillance? And why is vigilance a separate entity from the two other surveillance activities? Don't fret! Today, we are exploring post-market surveillance, market surveillance, and vigilance and telling [...]
While post-market clinical follow-up (PMCF) played a part in the MDD (Directive 93/42/EEC), the updated Medical Device Regulation (MDR, 2017/745) introduced stricter rules for post-market surveillance, including post-market clinical follow-up. The increase in clinical data requirements and the need for a proactive post-market surveillance system have left many medical device manufacturers unsure of how to [...]
Post-market surveillance is a significant part of any medical device manufacturer's responsibilities, especially since the European Medical Device Regulation (MDR, 2017/745) implementation put an extra focus on post-market surveillance and vigilance activities. Today we are looking at the specific obligations required of the medical device manufacturer, focusing on a proactive post-market surveillance system that collects [...]
We've explored post-market surveillance (PMS) for medical device manufacturers many times, for example, in our articles on post-market surveillance under the MDR, MDR post-market surveillance compared to the IVDR, and the relationships between literature search and clinical evaluation reports, PMS Vigilance, PMCF, and PSURs. But what are the responsibilities of the national regulatory authorities, [...]
The Medical Device Regulation 2017/745 (MDR) and the In Vitro Diagnostic Regulation 2017/746 (IVDR) are two sides of the same regulatory coin in almost all aspects: both regulations seek to set up a regulatory system that will increase safety and efficiency in the European medical device market; both include collecting clinical evidence and demonstrating an [...]
A systematic review of the literature, including both peer-reviewed and grey literature (e.g., conference abstracts), is recommended as part of a clinical evaluation report or CER and the post-market surveillance of medical devices. The objective of the literature search is to obtain information about the safety and performance attributes of similar products for which [...]
