Medical Device Regulation

Medical Device Legislation

Medical device regulatory requirements are undergoing a period of transition, with the new Medical Device Regulation 2017/745 (MDR) and In-Vitro Diagnostics Regulation 2017/746 (IVDR), both having been officially published in May 2017 by the European Commission. This publication is heralding a new era of control and requires that the Medical Device Directive 93/42/EEC (MDD) and In-Vitro Diagnostic Directive (98/79/EEC), which has been the primary legislative platforms since the early ‘90’s, be phased out over the next three and five years respectively.

The planned overlap, or ‘transition period’ for the two legislations, has now commenced and will continue until the MDR and IVDR become fully applicable in 2020 and 2022, as can be seen in the diagram below. Because of this current dual applicability, the following pages detail the requirements of both current and future platforms.

This document also highlights the main areas of change, although it should be remembered that compliance is not an exact science.  Each company should therefore assess the impact relative of each to their business.