MH Life Sciences

Thursday 9 November 2017

The Medical Devices Regulation

The regulatory regime for medical devices, technologies and diagnostics is complex and undergoing its most significant change for thirty years.

The EU Medical Devices Regulation (MDR) replaces the current Medical Devices Directive. The MDR entered into force on 25 May 2017, marking the start of a three-year transitional period for manufacturers selling medical devices in Europe.

Crucially, the MDR does not include any provisions for “grandfathering” existing approved devices. Every device will need a new CE Mark.