MedTech Europe, the European trade association which represents the medical technology industry, has published on July 9 a position paper voicing the growing concerns of the industry on the halted progress in the implementation of the Regulation (EU) IVDR 2017/746 (In-vitro Diagnostic Medical Device Regulation – IVDR).
With the new IVD Regulation entering into force on 26 May 2022 and introducing significant changes in the IVD regulatory framework, MedTech decided to express its alarm over the successful transition to the new Regulation.
Although the industry has remarked its support to the new IVD Regulation and its commitment to ensuring its full realization, MedTech Europe highlighted its concerns over the many missing critical building blocks needed in the infrastructure.
The missing elements, according to the trade association, include guidance documents, EU reference laboratories, and common specifications. Furthermore, until the re-designated Notified Bodies infrastructure will be made fully available and functional, it will not be possible for manufacturers to obtain certifications of tests.
Further complications to the successful transition to the new IVDR have been caused by the Covid-19 pandemic, which inevitably put a brake on the implementation of the Regulation, and shifted the focus of Notified Bodies, Member States authorities, and manufacturers to the global health crisis. It is in this context that MedTech Europe put forward its call on authorities to address the current public health challenge and appropriately adjust the IVDR implementation activities to ensure the success of the new IVDR.
More specifically, MedTech Europe calls for a postponement of the May 26, 2022 date of application and extension of the ‘’grace period’’ to additional categories of IVDs.
Serge Bernasconi, CEO of MedTech Europe, underlined how the critical role of in-vitro diagnostic tests in the screening, diagnosis, prediction, and monitoring of medical conditions has been proven once again during the COVID-19 pandemic, where tests represent an indispensable element of health crisis management and a crucial aid to combat and recover from the impact of the virus.
It is therefore fundamental for MedTech Europe, now more than ever, to act quickly to ensure the EU has a well-functioning and reliable regulatory framework for diagnostics.
Regulatory Affairs Department
Reference: MedTech Europe: Ensuring a successful transition to the new IVD Regulation in light of COVID-19 https://www.medtecheurope.org/resource-library/ensuring-a-successful-transition-to-the-new-ivd-regulation-in-light-of-covid-19/
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