Vigilance Guidance Provides Greater Clarity On MDR Requirements

By Belinda Dowsett

In light of the new requirements set out in the European Medical Device Regulations (MDR 2017/745), manufacturers are now placing increased emphasis on vigilance as they navigate regulatory processes. The Medical Device Coordination Group (MDCG) has responded to industry needs by issuing updated guidance on Device Specific Vigilance, aimed at providing clarity on obligations for different types of medical devices.

This guidance covers the identification, reporting, and analysis of serious incidents, as well as corrective actions to ensure compliance with safety standards. Unlike previous regulations, both the MDR and the In Vitro Diagnostic Regulations (IVDR 2017/746) outline stricter mandates for reporting, thereby enhancing transparency in device performance and safety across various device classes.

This article delves into the impact of these developments on manufacturers, offering valuable insights into the changing landscape of device safety and compliance within the European Union.