The Medical Device Regulation (MDR) 2017/745 has significantly enhanced requirements for post-market surveillance (PMS) to ensure the continuous safety and performance of medical devices in the European Union. Manufacturers must establish a robust post-market process to comply with these regulations, maintain market access, and improve patient outcomes. The post-market surveillance system shall be suited to …
In the ever-evolving field of medical device regulation, the Medical Device Regulation (MDR) has introduced significant changes to enhance transparency, safety, and traceability. One crucial aspect of MDR compliance is Trend Reporting, a mechanism designed to identify and address emerging issues related to medical devices. This article delves into the intricacies of MDR Trend Reporting, …
PMCF (Post Market Clinical Follow-Up) is maybe one of the most challenging new MDR (EU 2017/745) requirements. As many of you know, MDR has increased requirements for clinical evaluation and market surveillance. The importance of the clinical data shows its effects for post market surveillance as a more detailed PMCF process. Of course this shall …