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 […]
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 […]
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 […]
We had the first reading vote by the European Parliament on 2 April. Let’s put it in perspective. The previous last important iterations in the legislative process are the EP’s plenary vote on 22 October 2013 and the Council’s discussion of the MDR proposal with respect to reprocessing and market access mechanism. Parliament The Parliament’s plenary […]
This Tuesday morning 10 December the EU Council will meet to discuss the dossier of medical devices and IVDs revision for the last time during the Lithuanian Presidency, from 10:00 to 12:00. It looks like live coverage by video feed is available, but you can also download the coverage afterwards, see the links in this […]
That’s right: it’s 10 minutes to midnight for EU medical devices regulation in the cold war between the ENVI committee and the industry with the upcoming vote in the European parliament’s plenary tomorrow on 22 October. The proponents of the ‘swift and proportionate’ procedure via a centralized EU agency, like currently happens with certain medicinal products […]
This time I’d like to entertain you with some aspects of some of the dryest matter that I work with as lawyer: technical rules regarding competence and standing under EU law. However, this subject matter is very important for medical devices companies in the light of the large number of delegated and implementing acts for […]
Compromising is time consuming business, that’s for sure. And sometimes it’s not easy to reach compromises. Apparently the ENVI Committee members were not able to reach compromises timely, because the postponed vote on the medical devices regulation proposals that was scheduled for 18 September has now been … postponed, again. The discussion of the regulation […]
Everybody (I would hope so for the sake of cultural standards) will be familiar with the famous Monty Python sketch about the two bored pilots that decide to make things interesting by causing panic with the passengers by means of a series of increasingly urgent and ill-considered messages over the airplane intercom. This sketch almost […]