The European Union’s (EU’s) new regulation for medical devices sold or imported into the EU are now fully applicable to all devices.
As of May 26, 2021, all new and existing medical devices must now conform with the requirements detailed in the EU’s Medical Device Regulation (2017/745, also known as the MDR).
Published in the Official Journal of the European Union in 2017, the MDR replaces the EU’s Medical Device Directive (93/42/EEC) and the Active Implantable Medical Devices Directive (90/385/EEC). The MDR originally provided medical device manufacturers three years to ensure that existing medical devices were compliant with the requirements under the new regulation. The EU Commission extended that period one additional year in April 2020, due to the impact of the COVID-19 pandemic on healthcare institutions, medical device developers, and regulatory authorities.
The MDR’s companion regulation on in-vitro diagnostic medical devices (2017/746, known as the IVDR) provided in-vitro medical device manufacturers with a five-year transition period and is fully applicable to all in-vitro devices as of May 2022.
The full application of the MDR and IVDR represents the culmination of a nearly 10-year process that began in 2012 when the European Commission first published initial proposals for the new regulations.