In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”). This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here). The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”. Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR. The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR. Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.
In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025.
The IVDR has been applicable in the EU since 26 May 2022 (one year later than the MDR, which took effect on 26 May 2021). The IVDR has not changed the fundamental principles of how IVDs are regulated and IVDs are still subject to a system of self-certification, notified body assessment (in certain instances) and CE marking. Notably, however, the IVDR introduced a new classification system that means that ~80% of IVDs (namely any IVD falling in Class B, C or D) require notified body assessment, compared to less than 10% under the prior IVD Directive 98/79/EC (the “IVDD”). Further information on the key changes under the IVDR can be found in our prior blog post here.
Following calls from industry (triggered by the lack of notified body capacity) and also challenges caused by COVID-19, the European Commission initially extended the transitional periods under the IVDR to allow companies (in certain instances) to continue to place IVDs on the EU market until 26 May 2025 for high-risk devices (Class D), 26 May 2026 for medium-risk devices (Class C) and 26 May 2027 for lower-risk devices (Class B and Class A sterile devices), provided they comply with the IVDD. As explained below, the Commission now proposes to extend these periods to allow manufacturers of relevant devices more time to ensure full compliance with the requirements of the IVDR.
Key Elements of the Proposal
- New IVDR Transitional Periods
The availability of safe and effective IVDs is essential to patient care with around two thirds of all clinical decisions based on information provided by IVDs. Although several years of transitional period remain for lower risk IVDs, the transitional period for high-risk IVDs is currently set to end on 26 May 2025. To ensure readiness of the sector, and the continued safety of patients, the European Commission is proposing the below extended transitional periods:
- 31 December 2027 for high risk IVDs (Class D);
- 31 December 2028 for medium risk IVDs (Class C); and
- 31 December 2029 for lower risk IVDs (Class B and Class A sterile devices).
In order to benefit, the extension will be subject to conditions similar to those adopted for the MDR transitional period, including an obligation on manufacturers to (1) take active steps to transition to the new rules, (2) continue to place on the market devices meeting high safety standards, and (3) put in place a quality management system in accordance with Article 10(8) IVDR at the latest by 26 May 2025.
- EUDAMED Roll Out
The EUDAMED database will allow members of the public and healthcare professionals to access information about medical devices available on the EU market, improving the transparency and coordination of information regarding such devices.
EUDAMED comprises of six modules covering: (1) UDI/Devices, (2) Actors, (3) Notified bodies/Certificates, (4) Post-Market Surveillance and Vigilance, (5) Market Surveillance, and (6) Clinical investigations/Performance studies. While modules (1)-(3) have been finalized, modules (4) and (5) are not expected to be complete until Q2/2024 and module (6) not before Q3/2026. Under current rules, the use of EUDAMED is not mandatory until all modules are fully functioning and the Commission has published a notice to that effect.
In an effort to speed up the use of EUDAMED, and improve the traceability and transparency of medical devices, the European Commission is proposing the gradual implementation of finalized, audited and functioning EUDAMED modules. This will ultimately speed up the mandatory use of EUDAMED, with mandatory use of modules (1) – (3) expected as early as Q4/2025
- Obligation to Notify Interruptions in Supply
In response to feedback from across the sector concerning the supply of medical devices during the transitional periods of the IVDR and MDR, the European Commission is proposing to implement an obligation on manufacturers to inform relevant competent authorities and health institutions before they “cease, temporarily or permanently, the supply of a critical device.” This will ensure that relevant authorities and healthcare providers know in advance whether devices will be discontinued and subsequently what the risk to patients will be.
Manufacturers will be required to notify their home competent authority of any “interruption [that] may result in serious harm or a risk of serious harm to patients or public health in one or more Member States”. Other than in exceptional circumstances, the manufacturer must provide such information at least 6 months in advance of the anticipated interruption.
This requirement will be implemented through an amendment to both the MDR and IVDR.
The proposals will now be forwarded to the European Parliament and Council for adoption. Separately, the Commission will in 2024 start its preparatory work for a targeted evaluation of the MDR and IVDR to assess how the legislation is affecting the availability of devices across the EU.
If you have any queries concerning the material discussed or medical devices more broadly, please contact members of our Food, Drug, and Device practice.