ESHG strongly recommends that Article 5-§5 conditions (d) to (i) for in-house exemptions are removed from the IVD Regulation, while conditions (a) to (c) are kept. Failure to do so will increase health care costs and jeopardize our ability to design precise “personalized” laboratory tests (necessary for precision medicine) and to adapt to shifting test needs (like repurposing instruments for covid-19 testing).

<link internal-link internal link in current>Read the full statement