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 not getting the attention that it deserves, especially because the IVD revision is sparking off volatile things. Medical devices definition First, there is the ill-considered idea to change the core of EU medical devices regulation (the definition of medical device), just because rapporteur Liese wants to regulate ‘life s [...] « Read the rest of this article on medicaldeviceslegal »