MedTech Europe has welcomed the adoption of the European Commission’s Proposal to amend the transitional provisions of the new EU In Vitro Diagnostic Medical Devices Regulation (IVD Regulation).
With the adoption by the Council of the European Union, which follows a corresponding plenary vote of the European Parliament, MedTech Europe says both EU legislators recognise the need for a workable transition into the new European regulatory framework for IVD medical tests.
The amendment mitigates the immediate and urgent risk that medical tests for all clinical areas, which are already on the market today and including those detecting SARS-CoV-2, would no longer be available as of May 2022.
Concretely, the adopted text contains three key points:
- It maintains the date of application of the IVD Regulation of 26 May 2022;
- It extends the transitional provisions for most IVDs already on the market, according to their risk class;
- It provides additional transition time for most of the requirements pursuant to in-house assays.
Serge Bernasconi, CEO of MedTech Europe, said: “The decision to amend the transitional provisions of the IVD Regulation comes at the last moment to ensure that medical tests can remain available to Europe’s patients and healthcare systems. It is now important that regulators address the remaining critical questions that will support the certification before the end of the new deadlines of more than 32,000 medical tests on the market today, as well as the certification of innovative diagnostics that are in the pipeline and will address unmet medical needs.”
The trade association feels there are at least two outstanding issues that need urgent and continued attention by EU regulators:
Firstly, manufacturers and their notified bodies need timely EU guidance on how to handle changes that may occur to existing tests, for example changes of components due to supply chain shortages. Such guidance is needed ahead of May 2022, since as of that date tests with ‘significant’ changes cannot apply the transitional provisions.
Secondly, the capacity of IVDR designated notified bodies are still a critical bottleneck. At present, more than 50% of all IVD manufacturers do not yet have a notified body to certify their existing or new tests. It can take a total of 12-24 months to sign a contract with a notified body, complete the certification work and deliver the tests to hospitals, clinical laboratories, and patients. To make the best use of the extended transitional provisions, it is equally critical that all essential infrastructure to implement the IVD Regulation be put in place as soon as possible, including sufficient notified bodies and other elements for example, to enable certification of highest risk medical tests and companion diagnostics.
MedTech Europe will continue to work with EU decision makers and stakeholders to ensure the successful implementation of this Regulation for the benefit of patients and healthcare systems in Europe.
