In Vitro Medical Device Regulation enters into application

As of today (May 26), new rules on in vitro diagnostic medical devices (IVDR) such as HIV tests, pregnancy tests or COVID-19 tests, will be applicable in the EU. The rules will better protect public health and patient safety in respect to these devices, bringing EU law in line with technological advances and progress in medical science. By aligning market access requirements in the different EU Member States, it also safeguards fair market access for manufacturers.

Medical devices, including in vitro medical devices, have a fundamental role in saving lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of a disease.

In summary, the Regulation on in vitro diagnostic medical devices introduces three important advances: