EU Commission proposes IVDR & MDR amendments: Eudamed rollout, supply interruption reporting, extended transitional provisions for certain IVDR devices.
Firstly, it aims to further extend the transitional period for certain IVDs to mitigate the risk of shortages of these products, especially of high-risk IVDs (Class D under the IVDR), which are used, for example, to test for infections in blood or organ donations or for blood grouping for transfusions.
Secondly, the proposal aims to enable a gradual roll-out of the electronic systems integrated into the European database on medical devices (‘Eudamed’) that are finalised, instead of deferring the mandatory use of Eudamed until the last of the six modules is completed.
In addition, the proposal aims to impose a requirement on manufacturers to give prior notice before interrupting the supply of certain critical medical devices and IVDs.
Proposal to amend MDR and IVDR – transitional provisions IVDR – gradual roll-out EUDAMED – interruption of supply
To ensure availability of safe devices, essential for healthcare systems, and protect patient care. The latest available data shows that a high number of IVDs currently on the market has not factored in the new rules (nor has been replaced by other devices), meaning that those devices would no longer be available. The number of devices which have not factored in the new rules and are not expected to transition in time is particularly high for high risk IVDs (class D).
The proposed new transition periods will depend on the type of device, specifically its risk class under the IVD Regulation. There will be:
The new transitional provisions would only apply to ‘legacy devices‘, meaning devices covered by a certificate or declaration of conformity issued under the previous legal framework (notably Directive 98/79/EC), if they meet the following conditions:
This proposal of the Commission aims to speed up the launch of the parts of EUDAMED that are already finalized, so that it is mandatory earlier (as from late 2025).
Currently, the first three of the six modules are available for voluntary use (actor registration; UDI and device registration; notified bodies and certificates). Two other modules (market surveillance; post-market surveillance and vigilance) are expected to be completed in 2024. The module covering clinical investigation/performance study will not be completed before Q3 2026.
To ensure availability of devices, Member State authorities and healthcare providers need to know in advance whether devices will be discontinued, and whether such discontinuation may pose a risk to patients or public health. The Commission is therefore proposing that manufacturers provide this information to competent authorities, as well as distributors and healthcare providers. They have to provide this information six months in advance, so that national authorities and healthcare providers have enough time to consider mitigating measures to ensure patient safety and a high level of public health.
Specifically for devices intended for small patient populations like children or persons with a rare disease (“orphan devices”) a new guidance, is being developed. The guidance is expected to significantly help the certification of existing orphan devices in accordance with the MDR/IVDR, by addressing the specific challenges of clinical evidence requirements for these types of devices.
More information can be found here:
Questions and Answers on in vitro diagnostics and the European Database on Medical Devices (EUDAMED)
This proposal to extend the transitional period for certain devices potentially provides IVD manufacturers with more time to transition the existing devices from the IVD Directive 98/79/EC to the IVDR 2017/746. Specific conditions would apply for a manufacturer to make use of the transitional provisions, one of these being a deadline by when at the latest your conformity assessment to IVDR must have been submitted to the notified body. However, not all aspects are delayed. For all devices, including those making use of the transitional provisions, the IVDR requirements relating to post-market surveillance, market surveillance, vigilance, registration of economic operators, and of devices apply, instead of the corresponding requirements in Directive 98/79/EC, since 26 May 2022. In addition, this proposal also introduces the requirement for having an IVDR-compliant quality management system no later than 26 May 2025. We therefore would like to stress the importance of continuing all your transition efforts and preparing for certification under the IVDR as soon as possible. Do not wait until the end of the transition period.
Of final note, this is still a proposal at this point in time, it will now be put forward to the European Parliament and Council for adoption.