Last week we went past DoE (Date of Entry into force) of the MDR plus three years, and the date on which the MDR was supposed to have become applicable. As you, my dear readers, will all know by now, the date of application (DoA) has been moved with a year now as the outcome […]
You must be thinking that this blog is a bit quiet while a lot is happing – and that’s exactly the case. I’ve been very very busy being Batman (see picture on the left). A lot of companies in devices still do not seem to get what the enormous change brought about by the MDR […]
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 my firm Axon Lawyers has a YouTube channel, why not use it more? I was recently invited as speaker to the DIA Meeting on Personalized Medicines and Companion Diagnostics in Washington DC (well, Alexandria, VA, an affluent suburb of DC), on 6 November 2013. However, due to an unfortunate mix of circumstances I had to […]
While the medical devices and IVD regulation proposals trickle through the legislative process and people concentrate on details like I have done on this blog as well, it might be nice to have a higher level picture. So that’s what my UK colleague Alex Denoon and I prepared for a recent webinar, and what we […]
As promised, here is an analysis of the IVD amendments further to the report provided by rapporteur Liese, with numbers 75-237 and 238-399. Not that as many as the medical devices ones, but still a lot – and no less complex. I won’t repeat all the procedural proposals that are both in the medical devices […]
That’s a good term to describe a situation of limited situaltional awareness resulting from many things happening at the same time very quickly, and a good term to decribe the situation we are currently in with the medical devices and IVD regulation proposals and the amendments proposed. Tsunami of amendments The period for tabling amendments […]
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 […]