The Commission welcomes the adoption by the European Parliament today of measures, proposed by the Commission in January 2024, to improve the availability of in vitro diagnostics (IVDs) for patients and healthcare providers. These measures include granting more time to companies to transition to the new EU rules on IVDs, introducing a new obligation on manufacturers to inform national authorities and the health sector in case of disruption of supply of certain medical devices and allowing for the gradual roll-out of the European Database on Medical Devices – Eudamed. The measures give more time to consider possible actions to safeguard patient care in instances where certain devices are discontinued and increase transparency regarding medical devices on the market.
The availability of IVDs, such as HIV or hepatitis tests, is crucial for patients. A considerable number of IVDs currently on the market do not yet comply with the EU rules which have been applicable since May 2022. Subject to certain conditions, the new rules give more time for manufacturers to transition to the new requirements without compromising safety and mitigate the risk of shortages…
