The European Society
of Human Genetics

News details

ESHG Policy Statement on Regulation EU 2017/746 (the IVD Regulation)

Regulation EU 2017/746 (the IVD Regulation) is a threat to both precision medicine and crisis management if the Article 5-§5 conditions (d)-(i) are not removed

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).

Read the full statement