The European Union’s (EU’s) new regulations applicable to medical devices and in vitro diagnostic devices have finally been published.
The EU’s new regulation on medical devices (2017/745, also referred to as the Medical Device Regulation, or MDR) and the new regulation on in vitro diagnostic medical devices (2017/746, also referred to as the IVDR) were published in the May 5th issue of the Official Journal of the European Union. The new regulations replace the EU’s Medical Device Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Devices Directive (98/79/EC).
With the publication of the MDR, medical device manufacturers now have three years (until 2020) to ensure that existing medical devices are compliant with the new requirements. For in vitro device manufacturers, the transition period is five years (until 2022).
The publication of the MDR and IVDR represents the culmination of a legislative process that began more than five years ago in 2012, when the European Commission first published initial proposals for the new regulations.
Read the text of the MDR as published in the Official Journal.
Read the text of the IVDR as published in the Official Journal.
