pms

MDR Trend Reporting

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, PMS and PSUR Requirements

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 …