Laboratory experts from the BioMed Alliance IVD Working Group released a new statement highlighting a looming threat for the diagnostic sector, the slow implementation of the new In Vitro Diagnostic Regulation (IVDR). They argue that urgent actions are necessary now to prevent a collapse of the diagnostic sector.
The application date of the new In Vitro Diagnostics Regulation is only one year away (26 May 2022) and there are widespread concerns that the implementation is not progressing quickly enough. To date, many critical regulatory elements are not in place and important guidance is still lacking, making it extremely difficult for the EU diagnostic sector to be fully prepared in time for May 2022. The new regulation proposes stricter safeguards for tests and additional elements in the regulatory framework for IVD tests. Under the new system, it is e.g. expected that 90% of tests will need assessment by Notified Bodies for the first time, but only 4 Notified Bodies have been appointed so far.
With the majority of medical decisions made on the basis of diagnostic tests, serious consequences for the European healthcare system and patient care could follow. The BioMed Alliance has provided an overview of the implementation process and the steps to take and hopes that the issue will feature high on the EU agenda so pressing issues can be addressed. Read more here.