MedTech Europe published a new position paper ahead of May 2025 deadline for Class D IVDs. These are IVD devices of the highest risk-class. They are crucial for public health and any supply chain disruptions could have an enormous impact on patients. With the legacy period ending on 26 May 2025, the transition of devices from the Directive to the Regulation is taking longer than expected. In this context, MedTech Europe points out that it is necessary to extend May 2025 deadline for Class D IVDs.
In this position paper, MedTech analyses timelines for new certifications, harmonisation of conformity assessments, EURLs recommendations on the transition period, and a classification update of SARS-CoV-2 tests.
Timelines for IVDs certification for class D
As of December 2023, notified bodies issued at least 62 IVDR certificates for class D. As one certificate can cover more devices, the extact number of devices certified under the IVDR is unknown. Notably, class D certification takes 13-18 months in 50% of the cases. Thus, to obtain a certificate within May 2025, manufacturers should apply by the end of 2023.
Estimations suggest that as of July 2023, only one-fifth of class D devices on the EU market are undergoing IVDR certification. With their position paper, MedTech Europe expresses support for any measures that will keep the transition of devices, including Class D, available to the blood banks, laboratories, and patients needing them. MedTech suggests that Small and Medium Enterprises (SMEs) should be given particular attention. They often lack human and financial resources, making it challenging to invest in the IVDR transition. Data from MedTech Europe shows that 53% of SMEs and 6% of large companies did not have an agreement with a notified body under the IVDR as of October 2022. However, the increase in the costs under the IVDR has impacted both large and small companies, likely leading to some degree of discontinuation.
Medtech Europe encourages a more predictable and efficient path to certify Class D devices to ensure continuity and bring both innovations and legacy devices to Europe. As expressed also in another position paper on the Future Regulatory System, the association stresses the need for discussion to address efficiency, innovation, and governance in the IVDR.
Harmonisation of conformity assessment in the absence of EURLs
Despite the absence of the EU Reference Laboratories (EURLs), notified bodies have been able to proceed with the assessment of class D IVDs. For devices not yet covered by EURLs, notified bodies will have to continue aligning their approaches for conformity assessment and batch release. MedTech’s position paper welcomes notified bodies’ consideration paper to provide a framework for the verification process for Class D IVD medical devices in the absence of EURLs. The association also expressed their will to engage in discussion with notified bodies for a harmonised approach, including sharing experiences from their members.
Recommendations for the EU Reference Laboratory transition period
At the beginning of December 2023, the European Commission announced the designation of the first five EURLs. After the transition period, ending on 1 October 2024, the EURLs start their role in performance verification and batch release of class D IVDs, currently performed by notified bodies. MedTech Europe points out the importance of collaboration among authorities, EURLs, and stakeholders to ensure preparedness for mandatory activities. Moreover, the position paper lists different actions that EURLs need to undertake during this transition period to ensure that their tasks can be performed properly once mandatory:
- Set a network of national reference labs
- Form scope-specific sub-networks
- Agree on reference materials and set their acquisition plan
- Establish standard operating policies
- Align policies on independence, conflict of interest and confidentiality
- Lay down the rules according to which the fees are calculated
- Develop and establish the code of conduct
To enable EURLs, notified bodies, and manufacturers to interact during conformity assessment and batch release, the following actions are necessary:
- Prepare the template for contracts and payment of fees
- Set up templates and procedures for the notified body to inform the EURLs of class D devices to be covered and initiate the 60-day consultation procedure
- If applicable, the personnel trained have to install the instrumentation on EURL premises. In addition, this will require setting up plans for instrumentation maintenance.
MedTech Europe proposes that before 1 October 2024, the Joint Research Centre should assess each EURL about their preparedness to carry out the batch release and performance evaluation within the deadline. The associations recommend the assessment take place three months before the end of the transition. The Joint Research Centre could involve notified bodies when conducting the assessment.
Classification update of SARS-CoV-2 tests
SARS-CoV-2 tests are class D IVDs. MedTech estimates that around 40% of Class D applications could come for devices that detect SARS-CoV-2. In light of the latest positive developments on COVID-19 infections, such as For MedTech Europe, the current classification would foresee that such tests should fall into class B. MedTech Europe proposes that the MDCG Guidance on Classification should be updated to reflect the current epidemiologic status of an infectious agent, consequently down-classifying COVID-19 tests.
The full text can be found in our Library of Documents dedicated to IVDR position papers.