The European Commission is proposing an extension to the transition period for the forthcoming In Vitro Diagnostic Medical Devices Regulation (IVDR), with the aim of ensuring patient care via continued availability of 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).
The IVDR has been applicable since May 2022 and aims to modernise and upgrade the EU framework for in vitro diagnostics (IVDs) to ensure their safety for patients. However, the available data shows that today a considerable number of IVDs currently on the market do not yet comply with the new rules nor have been replaced by new devices. To improve the availability of such essential devices, this latest measure proposal gives more time for manufacturers to apply the new rules, under certain conditions, without compromising safety requirements.
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 aims to speed up the launch of the parts of EUDAMED that are already finalised, so that it is mandatory from late 2025. The Proposal will now be put forward to the European Parliament and Council for adoption
The Commission will begin its preparatory work for a targeted evaluation of the legislation on medical devices this year. The evaluation should assess how the legislation is affecting the availability of devices, as well as looking at the additional costs and administrative burden linked to the implementation of legislation, especially for small to medium enterprises.
The In Vitro Diagnostic Medical Devices Regulation (IVDR) established a new regulatory framework for in vitro diagnostic medical devices, such as HIV tests, pregnancy tests or COVID-19 tests.
The latest proposal can be read in full here: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=COM:2024:43:FIN