Counts here are a floor, never a total: they cover the 326 consultation files tracked so far (29,503 submissions, mostly 2025–26), so an organization's real filing history is larger, not smaller.
The proposed relaxations within the IVDR legislation can have a positive impact on the development, implementation and application of LDTs within diagnostics. The increased flexibility and simplified procedures contribute to a more efficient use of clinical trials, which can ultimately lead to better patient care and innovation in medical diagnostics. 1.
Filed in Dutch · English published by the European Commission
1. Properly functioning CE labelled tests are taken out of production, as it is costly for manufacturers to comply with the CE IVD standard. This reduces the quality of diagnostics because alternatives are less of quality or do not exist at all. This cannot be the intention. 2. Exchange of LDTs in the absence of a CE IVD alternative (e.g. rare diseases or multicer studies) is not possible under current legislation.
Filed in Dutch · English published by the European Commission
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