The IVDR is the current regulatory basis for placing on the market, making available and putting into service in vitro diagnostic medical devices on the European market. It was published in the Official Journal of the EU on 5 May 2017, and entered into force on 26 May 2017, gradually replacing the EU’s former Directive on in vitro diagnostic medical devices (98/79/EC).
The IVDR differs in several important ways from the EU’s previous directive on in vitro diagnostic medical devices. In addition, following the publication of Regulation (EU) 2022/112 of the European Parliament and of the Council of 25 January 2022, the transition period depends on the class of the IVD device under the current Directive and future Regulation as well as additional conditions.
The infographic below illustrates the key changes, timeline, step-by-step guide to IVDR certification, as well as a brief look into TÜV SÜD's medical device testing service which is completely independent from the Notified Body.