MedTech Europe has raised the alarm on the halted progress in implementing the EU’s In vitro Diagnostic Medical Device Regulation (IVDR).
MedTech Europe is the trade association which represents the medtech industry.
The new IVDR will come into force on 26th May 2022 and will introduce significant changes in the regulatory infrastructure of the IVD sector. However, MedTech Europe highlights how the industry remains concerned that many critical building blocks needed in the infrastructure are not currently available. This includes guidance documents, EU reference laboratories, and common specifications. Additionally, notified bodies must be re-designated against considerably strengthened requirements, and without this infrastructure being made fully available, the certification of tests cannot be completed.
The Covid-19 pandemic has added additional challenges, as it has shifted the focus of Member State authorities, laboratories, health institutions and the IVD manufacturers away from IVDR implementation, to the global health crisis. The vital role of diagnostics has, however, been proven in the Covid-19 pandemic, where tests represent an indispensable part in managing the acute crisis and in supporting effective exit strategies.
Serge Bernasconi, CEO of MedTech Europe, stated that the “diagnostics industry continues to be committed to helping Europe combat Covid-19 and works towards recovery from the crisis. However, the pandemic impact on the IVDR implementation has been considerable, and this must be neither underestimated nor ignored.”
“MedTech Europe and the diagnostics industry are ready to fully engage in discussions with authorities and stakeholders to find workable solutions and make the implementation of the new IVD framework successful,” Bernasconi added.
MedTech Europe has published a position paper outlining the growing concerns of the sector. The organisation requests urgent solutions from authorities to address these concerns, in order to ensure that existing and new diagnostic tests will be available for patients and healthcare systems.