The wait is nearly over for the official publication of the European Union’s (EU) new regulations applicable to medical devices and in vitro diagnostic devices.
According to a posting on the website of the Emergo Group, the European Parliament has approved the final versions of the EU’s Medical Device Regulations and the In-Vitro Diagnostic Regulations. The new regulations are expected to be published in early May in the Official Journal of the European Union and will take effect 20 days from publication, sometime in June 2017.
Once in effect, the new MDR and IVDR will 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). The MDR provides manufacturers with a three-year transition period to bring existing medical devices into compliance with the new requirements, while the IVDR provides a transition period of five years.
The adoption of the MDR and IVDR by the European Parliament represents the culmination of a legislative process that began more than five years ago in 2012, when the European Commission first published initial drafts of the new regulations.