While Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDMDs) has been applicable since May 2022, data shows that a significant number of in vitro diagnostic devices currently on the market are not compliant with the new planned rules and will not be able to remain on the market. In view of this alarming data, and in order to guarantee the availability of IVDDs, on January 23, 2024 the European Commission proposed measures to facilitate the transition to this regulation. Following the example of the successive changes to the conditions for entry into force of Regulation (EU) 2017/245 on medical devices, the Commission is proposing here: a conditional extension of the transitional period for entry into force of the IVDMD, prior notification in the event of discontinuation of supply of medical devices and in vitro diagnostic medical devices, and an acceleration of the entry into force of the EUDAMED database.

We are delighted with this measure, which echoes the concerns expressed by all those involved in the sector.

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A longer transition period for conditional IVDDs

This proposed amendment aims to mitigate the risk of a shortage of IVDDs by giving manufacturers and Notified Bodies (NBs) more time to meet the requirements necessary to implement the regulation, but only under certain conditions.

For the record, the current provisions set the following initial deadlines (article 113 RDMDIV): May 26, 2023 for class D IVDDs, May 26, 2025 for classes B and C, and May 26, 2027 for class A.

The proposal provides for an additional period, which varies according to the type of device concerned:

• Devices posing a high risk to individual and public health, such as HIV or hepatitis tests(class D), would benefit from a transitional period until December 2027. The need for additional time for these D classes is all the more necessary given that they represent around 4% of the market, and their conformity assessment is cumbersome.
• Devices with a high individual and/or moderate public health risk, such as cancer screening tests(class C), would benefit from a transition period until December 2028;
• Low-risk devices, such as pregnancy tests(class B) or sterile devices like blood collection tubes(class A), would benefit from a transitional period until December 2029.

The application of the extended transition period will be subject to conditions, which should be similar to the approach adopted by Regulation (EU) 2023/607 for the extension of the RDM transition period.

The conditions envisaged will ensure that only manufacturers who actively take the necessary steps to comply with the new rules can benefit from this extra time (vigilance, post-marketing obligations, commitment to a NB, etc).

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The proposal also includes an obligation for manufacturers to give prior notification of the discontinuation of supply of their IVDDs or other critical MDDs placed on their market in accordance with the transitional provisions set out in Article 110 of Regulation (EU) 2017/746 and Article 120 of Regulation (EU) 2017/745. This proposal would entail the introduction of a new Article 10a to both the IVDR and MDR regulations.

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Mandatory prior notification in the event of marketing discontinuation applicable to IVDDs and DMs

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In order to anticipate possible shortages linked to the cessation of marketing of devices that will not make the transition to the Regulation, Article 1 of the proposal introduces a new Article 10a, which lays down the obligation for manufacturers to notify in advance the interruption of the supply of their IVDDs and certain critical DMs, the list of which is to be defined, to the competent authorities, but also to user healthcare establishments or healthcare professionals, as well as to distributors to whom they supply these devices directly. Information deadlines should be set at six months, to enable authorities and healthcare providers to find solutions that guarantee patient health and safety.

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EUDAMED's gradual implementation: the need for greater transparency

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Another measure proposed by the European Commission is to speed up the operational launch of EUDAMED.

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It therefore proposes amending article 34 of the RDM to do away with the current EUDAMED entry-into-force arrangements conditional on the announcement of the full functionality of all its modules. Implementation of the various modules should thus be gradual, and the launch of modules already finalized will be accelerated (from the end of 2025). This proposal has been extended to include RDMDIV.

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This accelerated implementation should enhance transparency in the EU by providing an overview of all medical devices available on the European market.

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Next steps

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The proposal still needs to be adopted by the European Parliament and the Council. The proposal will now be submitted to the European Parliament and the Council for adoption.

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The Commission is also planning to start preparatory work this year to evaluate the legislation on medical devices. At the heart of its concerns are the way in which legislation affects the availability of devices, and implementation issues relating to costs and administrative burdens, particularly for SMEs.

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