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 […]
While everybody in the medical devices industry is still reeling from the ENVI vote results (of which we still don’t know what they are in detail because the documents have not been published yet), the Commission finally issued the recommendation on unannounced audits – I was starting to get worried it would never be issued […]
Juridische kanttekeningen bij het paardenvleesschandaal. Over de gedaantewisseling van een paard, voedselveiligheid en misleiding van de consument. lees meer …
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 […]
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 […]
Wednesday 16 October Medical Software & AppsAxon organizes a seminar addressing how to develop compliant medical software and how to determine applicable rules for medical software.Program and invitation …
If you are active in the medical software field in the Netherlands you may probably be aware already that the the Dutch healthcare Inspectorate IGZ has announced that it will rigorously enforce medical devices law against medical software that they consider a medical device as of 1 January 2014. They have said so pretty clearly […]
It’s time for a celebration! Why? Did the ENVI committee magically produce a proposal that makes a lot of sense, and ahead of time? Unfortunately not – we still have to wait and see what happens on 18 September. But you can count on me writing about it. There will be lots of interesting discussions […]
I have just written annotations to the Abbvie and Intermune cases under EU pharmaceutical law for the next issue of the Dutch legal journal Jurisprudentie Geneesmiddelenrecht (in Dutch, sorry) but of course that started a train of thought on how these cases might influence the medical devices industry, especially because I have already mentioned that these […]