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.
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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 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 a considerable number of in vitro diagnostics currently on the market do not yet comply with the new rules nor have been replaced by new devices.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.
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 Commission says 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. The proposal from 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).
The Proposal will now be put forward to the European Parliament and Council for adoption.
The Commission will start 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, in particular for devices with specific characteristics (e.g. paediatrics, orphan, innovative devices). In the assessment, special attention may also be given to costs and administrative burdens stemming from the implementation of legislation, especially for SMEs.
In response to the move from the European Commission, MedTech Europe said it welcomes the announcement to start preparatory work for a targeted evaluation of the legislation in 2024, in addition to taking more immediate actions.
MedTech Europe supports any measures that keep devices available to the patients who need them and says the additional time given under the IVDR must be used by the European Commission, Medical Devices Coordination Group (MDCG), Notified Bodies, and other actors to identify blockages and rectify existing issues, to enable all manufacturers to transition on time and meet post-market requirements.
The body also said the integrity of the EUDAMED database and its practical implementation are essential for ensuring the success of a mandatory EUDAMED. MedTech Europe says that five important conditions need to be met before any modules of EUDAMED are made mandatory.