Post Market Surveillance

Developing a medical device is not a one-step process. There are hundreds of little steps, from drawing the design to finalizing it to actually creating the device. Between all these steps, there is always [...]

One of the new aspects introduced in the European Medical Device Regulation 2017/745 (MDR) is post-market clinical follow-up (PMCF).   While PMCF is well-known in the pharmaceutical world, it is a relatively new concept in [...]

By now, most of us have struggled through at least one successful submission for MDR/IVDR, and we know they take time. Very doable, but no ones exactly surprised at home simple everything was to [...]

Requirements for post-market surveillance (among a host of other requirements for everything from classification to clinical follow-up) were never that elaborate in the In Vitro Diagnostics Directive (IVDD; 98/79/EC).   However, with the introduction of [...]

Obtaining the CE mark is one of the most significant milestones in the life of most medical devices. Unfortunately, it typically takes years and can exhaust even the most determined regulatory personnel. Nevertheless, getting [...]

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 [...]

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, [...]

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 [...]

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, [...]

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 [...]

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 [...]

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 [...]