MedWatch

Danish chamber of commerce says notified body should be followed up by reference lab

The Danish Chamber of Commerce is urging the Danish government to promote the establishing of a reference laboratory in Denmark, as the EU’s new rules concerning in vitro diagnostic equipment near.

Photo: Yasushi Wada/AP/Ritzau Scanpix

On May 26, the EU’s new In Vitro Diagnostic Medical Devices Regulation (IVDR) comes into force, and in connection with the new rules, a string of reference laboratories will have to be appointed across the EU to help test the effect and quality of in vitro diagnostic equipment.

In vitro diagnostic medical devices (IVDs) include Covid-19 tests but also many other tests for the diagnosing, preventing, screening and monitoring of diseases.

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