EU Parliament adopts new In Vitro Diagnostic Device Regulation

The IVD industry is about to undergo significant change. The EU Parliament has adopted the proposal for the IVD Regulation; this legislation will replace the current IVD Directive (98/79/EC), and brings with it an increase not only in the requirements of manufacturers wishing to sell devices in Europe, but also in the number of manufacturers that will be required to use a Notified Body to do so.

The final text will be published in the Official Journal of the European Union in May, and the Regulation will enter into force 20 days later. This will be the start of a five year transition period for manufacturers to meet the new requirements.

Read the full EU Commission press release 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.