On Friday 26 April, the European Commission welcomed the European Parliament’s adoption the previous day of the compromise text between the institutions aimed at improving the availability of in vitro diagnostics for patients and healthcare providers.
The EU Council still has to formally adopt the text, which will enter into force on the day of its publication in the Official Journal of the EU (see EUROPE 13355/12).
Among other things, these measures will give companies more time to implement the new EU rules on in vitro diagnostic medical devices: Class D devices (HIV or hepatitis screening tests) are granted a transition period until December 2027 and Class B devices (pregnancy tests) as well as Class A sterile devices (blood collection tubes) have a transition period until December 2029. A considerable number of in vitro diagnostic medical devices currently on the market do not yet comply with the EU rules applicable from May 2022.(Original version in French by Lionel Changeur)