In July 2020, the BioMed Alliance published a statement calling for urgent action to ensure optimal implementation of the EU In Vitro Diagnostic devices regulation (IVDR). The statement calls on the European Commission to take into account a number of actions that should be completed as soon as possible.
The application date for the new regulation on 26 May 2022 is approaching and adaptation to the new regulatory system is time consuming and requires a concerted effort from the European Commission, Member States and stakeholders. At the moment there are many steps that still need to be taken to ensure the regulatory system will be ready to continue guaranteeing the availability of novel and high-quality diagnostic tests.