The IVD industry is about to undergo significant change. The final text of the new European In Vitro Diagnostic Regulation (IVDR) has been published in the Official Journal of the European Union. Entry into force will commence on May 25th, marking the start of the transition period for manufacturers selling IVD devices into Europe.
The IVDR, which replaces IVD Directive (98/79/EC), has a transition period of five years. Manufacturers have the duration of the transition period to update their technical documentation and processes to meet the new requirements.
See the latest information from the EU Commission here"
The start of this long process of change occurred on 26 September 2012, when the European Commission adopted a Proposal for a Regulation of the European Parliament and of the Council on medical devices and a Proposal for a Regulation of the European Parliament and of the Council on in vitro diagnostic medical devices, which replaces the existing three Medical Device Directives.