Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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The Council of the European Union officially endorsed without any changes the proposal to amend IVDR and MDR.
On February 16th, 2024, the Council of the European Union officially endorsed without any changes the proposal published on January 23rd, 2024, by the European Commission to amend Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) and Regulation (EU) 2017/745 on medical devices (MDR) introducing an extension of the transitional provisions for certain in vitro diagnostic medical devices a gradual roll-out of Eudamed and the obligation of manufacturers to inform authorities and downstream economic operators in case of interruption of supply. The remaining step is the European Parliament’s endorsement and subsequent publication of the adopted text in the Official Journal of the European Union. The European Parliament is expected to vote on the proposal in April 2024.
The proposal has been addressed in an earlier Newsflash.
Summary of the proposed amendment
Why?
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available data shows that a high number of IVDs currently on the market has not factored in the new rules (nor has been replaced by other devices), meaning that those devices would no longer be available.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).
New IVDR transition timelines
The proposed new transition periods will depend on the type of device, specifically its risk class under the IVD Regulation. There will be:
shorter transition period for high-risk (Class D) IVDs (31 December 2027)
longer periods for medium and lower-risk IVDs, 31 December 2028 for Class C IVDs and 31 December 2029 respectively for Class B and Class A sterile IVDs.
The commission also proposes to postpone the application of one of the requirements for health institutions (Article 5.5 (d)), which is to show that there is no alternative and equivalent commercial device on the market. This requirement has been suggested to be delayed until 26 May 2030.
For non-sterile Class A devices the date of application remains 26 May 2022 and no transitional provisions have been proposed.
Under what conditions do these new timelines apply?
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:
- they continue to comply with the rules in force when they were placed on the market for the first time.
- there are no significant changes in the design or intended purpose of the devices.
- the devices do not present an unacceptable risk to the health or safety of patients, users or other persons, or to other aspects of the protection of public health.
- no later than 26 May 2025, the manufacturer puts in place a quality management system compliant with the IVD Regulation.
- for devices requiring an assessment by a notified body, the manufacturer submits an application to the notified body to transfer the device to the IVD Regulation by 26 May 2025 (class D), 2026 (class C) or 2027 (class B and A sterile IVDs).
- the manufacturer and the notified body sign a written agreement to proceed with conformity assessment shortly and no longer than 4 months after those dates.
Gradual roll-out EUDAMED
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.
Interruption of supply
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.
New guidance?
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).
What Does This Mean To You?
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.
On a final note, this is still a proposal at this point in time, the Council of the European Union officially endorsed the proposal, now the European Parliament will still have to vote on the text. Voting is expected to take place in April 2024.
About the Author
MSc Biomedical Sciences · Director Authorised Representative Services & Manager IVD – Regulatory Affairs
With over 20 years of experience in the diagnostics industry, Kirsten leads the IVD Regulatory Affairs business unit at QbD Group, guiding regulatory strategy and compliance across all IVDs with a focus on companion diagnostics.
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