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 […]
I had the pleasure of being invited to speak at the Health IT forum at the MEDICA conference last week on regulation of in, on and near body networks. Most of my day at the MEDICA I spent in the health IT hall, catching up on developments, particularly in the interesting Wearable Technology Pavillion with […]
It’s been a matter of a lot of speculation where the devices policy and HTA policy will finally end up in the European Commission. When the Commission-elect was presented, one of the interesting elements was that medicinal products and medical devices policy were going (back) to DG Enterprise. Remember that the new rapporteur for the medical […]
Finally things start moving again in EU medical devices regulation dossier: the new rapporteur for the Medical Devices Regulation was appointed, replacing Dagmar Roth-Behrendt. It’s Glenis Willmott The new rapporteur is UK MEP Glenis Willmott, of the S&D group in the European Parliament, who is certainly familiar with health issues as she has served for example as […]
Last week we finally had some new interesting developments (sorry for the boring silence on this blog but there was really nothing to report): the new Commission has completed and we are getting some first glances into how the new Commission sees EU medical devices policy going forward. With the unveiling of the new #teamjunkcer of […]
Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6. Harmonised standards […]
Some time ago I promised you a follow up on the 20 June Council meeting, but I also mentioned that it could wait for a while at the time because the outcome was not that spectacular or even unexpected. On 20 june the Council had its last deliberation on the medical devices and IVD regulation […]
It’s been somewhat quiet on this blog for some time, not only because I have been very busy with lots of interesting cases but mainly because there was not a lot going on in the medical devices regulatory developments field. Yes, market parties have been working on their input for the consultation about the Green Paper […]
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 […]
Are you still with me on where we are with the EU revision of medical devices and IVD legislation? If you are, you have strong tolerances for fast moving complexity – congratulations! – because so far it has been a wild ride so far with drama, denial and divergence. And it looks like it will […]