Transformation of European Medical Device Regulation: The role of expert panels

The European Medical Device Regulation (MDR) (EU 2017a) and In Vitro Diagnostic Regulation (IVDR) (EU 2017b) represent a transformative shift in medical device oversight, replacing outdated directives with comprehensive safety and transparency requirements. This review analyzes the historical context driving regulatory reform, including critical incidents involving medical devices that exposed weaknesses in previous regulatory frameworks, and examines the structure and function of expert panels established by the European Commission and European Medicines Agency. These panels provide independent scientific consultations through Clinical Evaluation Consultation Procedure and Performance Evaluation Consultation Procedure, supporting notified bodies in assessing high-risk devices while offering voluntary advice to manufacturers. The article evaluates the MDR's impact on manufacturers, notified bodies, patients, healthcare professionals, and market competitiveness, highlighting both enhanced patient protection and implementation challenges. Despite increased costs and extended certification timelines, the MDR positions the EU as a global leader in medical device regulation, balancing innovation with rigorous safety standards.