Today, the European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR), under certain conditions. With this revision, the Commission aims to ensure patient care by improving the availability of these essential healthcare products. The Commission is also proposing measures to enhance transparency in the Medical Device sector including by speeding up the launch of some elements of the European Database on Medical Devices – EUDAMED.
Ensuring the availability of in vitro diagnostics
In vitro diagnostics (IVDs) are tests used on biological samples to determine the status of a person’s health, such as HIV tests, pregnancy tests or COVID-19 tests. The availability of safe and effective IVDs is therefore essential for patient care. The Regulation, applicable since May 2022, aims to modernise and upgrade the EU framework for these products to ensure their safety for patients.
However, the available data shows that today a considerable number of in vitro diagnostics currently on the market do not yet comply with the new rules nor have been replaced by new devices. The situation is especially critical for high-risk IVDs, which are devices used, for example, to test for infections in blood and organ donations. To improve the availability of such essential devices, today’s proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements. This is very important, also taking into account the fact that many manufacturers producing IVDs are small and medium size enterprises…
