A new European regulation on medical devices came into force on 26 May 2021. Regulation 2017/745, also known as the Medical Device Regulation or simply “MDR”, replaces the previous directives 90/385/EEC and 93/42/EEC. It requires that all industry stakeholders comply with certain obligations, and applies to all medical devices, including those already on the market.
MDR entered into force on 26 May 2021.
MDR is applicable throughout the European Union.
MDR applies to all medical devices, including those already on the market.
The MDR creates a sound, transparent, durable regulatory framework that is recognised worldwide. It is directly applicable in all European Union (EU) countries and must not be transposed into national law.
The new regulation redefines the status and responsibilities of stakeholders. Whereas previous legislation only applied to manufacturers, authorised representatives, assemblers, importers and distributors, the MDR grants “economic operator” status and responsibilities to all of the sector’s stakeholders:
EUDAMED will enable healthcare users and professionals to access information on medical devices marketed in Europe, review reported incidents and track the progress of clinical investigations. A unique device identifier (UDI) will be assigned to each medical device to improve its traceability.
All Compat products are being made compliant with MDR requirements by the applicable dates: