genetic testing


EU Council also thinks genetic testing amendment in IVD regulation proposal is outside competence EU

In a previous blog I have addressed the genetic testing amendment to the IVD regulation proposal and have provided argumentation why this proposal is outside the scope of the legislative competence of…


The genetic testing amendment in the IVDR

The focus of the EU revision of medical devices regulation is fully on the medical devices regulation. The revision of the IVD directive is sort of happening in the background and is…


Rapporteur Liese's IVD regulation amendments are out: not so horizontal as expected

Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for ┬árapporteur Liese’s amendments for the IVD regulation proposal to also be published….

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