Medical Device Regulation (MDR)

Medical Device Regulation (MDR)

The Date of Application of the MDR is 26 May 2021 to update technical documentation to meet the requirements.

The Date of Application of the MDR is 26 May 2021 to update technical documentation to meet the requirements.

Red Overlay
Medical Devices Regulation
Medical Devices Regulation
Red Overlay

New Medical Devices Regulation now published

The new European Medical Device Regulation (MDR) has been published in the Official Journal of the European Union. The MDR entered into force on 25 May 2017, marking the start of the transition period for manufacturers selling medical devices into Europe.

What you need to know about the latest MDR

The MDR, which replaces the Medical Devices Directive (93/42/EEC) and Active Implantable Medical Devices Directive (90/385/EEC), has a transition period of three years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.

This long awaited text brings with it more scrutiny of technical documentation; it addresses concerns over the assessment of product safety and performance by placing stricter requirements on clinical evaluation and post-market clinical follow-up, and requiring better traceability of devices through the supply chain.

The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.  

See the latest information from the EU Commission here