With only one year to go before its date of application, BioMed Alliance healthcare diagnostic providers are seriously concerned about the status of implementation of the In-Vitro Device Regulation (IVDR) and its potentially disastrous consequences for diagnostic practice in the EU. From 26 May 2022 onwards, in vitro diagnostic tests will need to comply with the IVDR, which aims to secure clinical effectiveness and safety of medical tests. This is highly welcomed, but it also requires a transformation of the entire diagnostic sector, including major changes in the conformity assessment process of IVDs.

To date, many critical regulatory elements are not in place and important guidance is still lacking, making it extremely challenging for stakeholders to prepare fully for the new regulatory environment and thereby secure continuity of diagnostics after May 2022.