Medical Devices Regulatory Consultancy

EU REGULATIONS The expert panel in the field of in vitro diagnostic medical devices now accepts submissions from notified bodies for the Performance Evaluation Consultation Procedure | 14 October 2021 To prevent disruption in the supply of these essential healthcare products, the European Commission has proposed a progressive roll-out of the new In Vitro Diagnostic Medical Devices Regulation introducing substantial changes in the regulatory framework for in vitro diagnostic medical devices, such...