Please draw your attention once again to a matter of critical importance for our profession: the preservation of Article 5.5 in the ongoing revision of the IVDR.
The attached EFLM Position Statement provides a comprehensive assessment of the proposed IVDR reforms, with particular emphasis on the revision of Article 5.5.
While the proposal introduces a more proportionate and risk-based regulatory framework and reduces administrative burden, it is essential that these improvements do not compromise access to innovative, tailored, optimized and fit-for-clinical purpose diagnostic solutions.
Patients must remain at the centre of European diagnostic policy. Preserving Article 5.5, with the amendments proposed by EFLM, is crucial to ensuring continued access to high-quality laboratory-developed tests (LDTs) and to fostering innovation in laboratory medicine across Europe.
