Framework
EUIVDR — Market Surveillance
The EU IVDR 2017/746 establishes the framework for market surveillance of IVD medical devices by competent authorities of EU Member States. It defines the powers, activities, and coordination mechanisms for authorities to monitor compliance of IVD devices on the market, take corrective actions for non-compliant devices, and ensure ongoing safety and performance through proactive and reactive surveillance activities.
Overview
Background
Under Regulation (EU) 2017/746, market surveillance provisions for IVD devices were significantly strengthened, drawing on Regulation (EU) 2019/1020 on market surveillance and compliance of products. The IVDR established more detailed authority powers, coordinated assessment procedures, and enhanced information sharing between Member States to address the challenges of monitoring the diverse IVD device market.
Applicability
These requirements primarily apply to competent authorities of EU Member States responsible for market surveillance of IVD devices. However, manufacturers, authorized representatives, importers, and distributors must cooperate with market surveillance activities and are subject to corrective actions. The provisions also govern the role of the Medical Device Coordination Group (MDCG) in coordinating surveillance activities across the EU.