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 […]
You have a lot to look forward to next year unannounced notified body inspections will start (I hope you, your subcontracts and suppliers are prepared – if not, take a look at this instructive MedCert video), we will or will not close the project of the medical devices regulation revision before the elections during the […]
Well, we had the Council meeting last Tuesday on among other things Health, in which the medical devices regulation proposal was debated at quite a length. Where are we now and where are things going? My impression is that it’s a mixed bag or rather a wheelbarrow of frogs and it really depends on who you […]
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 […]
Today was an interesting day for medical devices in Europe. We had the EU Parliament’s plenary debate on the medical devices and IVD regulation proposals, and the subsequent vote on the highly appropriate or potentially devasting (depending on who you ask for comments) ENVI committee proposals. You can watch the whole debate video here, the […]
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 […]
The ENVI vote results that have already been hotly debated and opined upon are now finally out in the form of a draft European Parliament legislative resolution that the Parliament will vote on on 22 October. Now we can be sure what’s in the text, we can say something about details that are usually lost […]
Two weeks ago I made a prediction on some worst case scenarios that could come out of ENVI today. That turned out to be pretty accurate given what I know at this moment about the outcome of ENVI’s vote. ENVI did today what only happens in your worst nightmare: take several compromises and mash that […]
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 […]