Researcher – Photo © Alexander Raths – Fotolia
(BRUSSELS) – The European Commission proposed Tuesday to improve the availability of in vitro diagnostics and extend the time for companies to apply the In Vitro Diagnostics regulation.
The EU executive 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.
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 key to patient care. The In Vitro Diagnostic Medical Devices Regulation (IVDR), applicable since May 2022, aims to modernise and upgrade the EU framework for these products to ensure their safety for patients.
According to the EU executive, many in vitro diagnostics currently on the market do not yet comply with the new rules nor have been replaced by new devices. This situation is particularly 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, the Commission’s proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements. This is seen as important, as it takes into account the fact that many manufacturers producing IVDs are small and medium size enterprises.
Under the current provisions, these rules would apply from 26 May 2025 for high risk IVDs or 26 May 2027 for lower risk IVDs. The additional time granted to companies depends on the type of device:
- high individual and public health risk devices such as HIV or hepatitis tests (class D) would have a transition period until December 2027;
- high individual and/or moderate public health risk devices such as cancer tests (class C), would have a transition period until December 2028;
- lower risk devices (class B such as pregnancy tests and class A sterile devices such as blood collection tubes), have a transition period until December 2029.
- The proposal also requires manufacturers to give prior notice if they foresee the interruption of supply of IVDs or medical devices, so that Member States have more time to take action to ensure patient care.
The mandatory use of the European database on medical devices, EUDAMED, is key for the effective and efficient implementation of the Medical Device and IVD Regulations. It will increase transparency in the EU, providing an overview of all medical devices available on the European market. Today’s proposal of the Commission aims to speed up the launch of the parts of EUDAMED that are already finalised, so that it is mandatory earlier (as from late 2025).
In vitro diagnostics and the European Database on Medical Devices (EUDAMED) - guide
In Vitro Diagnostic Medical Devices Regulation
