The final text of the IVDR: first impressions
First impressions of the new EU #IVD regulation final text #medicaldevices #diagnostics #IVDs
First impressions of the new EU #IVD regulation final text #medicaldevices #diagnostics #IVDs
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 EU. To make it interesting I have also explicitly challenged the author of the amendment, rapporteur for the IVD regulation proposal Peter […]
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 […]
Now that rapporteur Roth-Behrendt’s proposed amendments for the medical devices regulation proposal are out, it could not take long for rapporteur Liese’s amendments for the IVD regulation proposal to also be published. And here they are. Basically this proposal is not jerking the wheel in the other direction as the Roth-Behrendt proposal does, but is […]