In May 2021, the BioMed Alliance published a new statement highlighting a looming threat for the diagnostic sector: the slow implementation of the new In Vitro Diagnostic Regulation (IVDR), a ticking bomb for the diagnostic sector. The laboratory experts of the IVD Task Force called for immediate actions to prevent its collapse.
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 and that the diagnostic sector is not ready. The new regulation proposes stricter safeguards for tests and additional elements in the regulatory framework for IVD tests, but so far, its implementation has been slow. As a result, not all elements and guidance are in place, making it harder for the diagnostic sector to prepare.