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European Commission on in vitro diagnostics. More availability is needed

MedExpress Team


Published Jan. 24, 2024 09:09

European Commission on in vitro diagnostics. More availability is needed - Header image
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The European Commission is proposing more time for companies to apply the In Vitro Diagnostic Medical Devices Regulation (IVDR). It is also proposing measures to increase transparency in the medical device sector, including by speeding up the launch of some elements of the European medical device database, EUDAMED.

- The priority of a strong European Health Union is to ensure that patients have access to medical devices and diagnostics whenever they need them. We must take immediate action to improve their availability. Today's proposal will provide assistance to the sector without compromising patient safety and care. Going forward, we are determined to analyze the root causes that are slowing down the transition, and we have committed to take appropriate action," says Stella Kyriakides, EU Commissioner for Health and Food Safety.

Ensuring the availability of diagnosticsin vitro

In vitro diagnostics (IVDs) are tests used on biological samples to determine a person's health status, such as HIV tests, pregnancy tests or COVID-19 tests. The availabi...

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