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 […]
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 […]
The scope of the concept of medical device is in constant flux. The EU amended the definition slightly in 2007 to accomodate for standalone software as medical device, the GHTF changed its definition not that long ago, and currently the EU is working on a new medical devices definition in the medical devices regulation proposal. […]
The e-labeling regulation has entered into full force a couple of months ago (1 March 2013), and I thought it would be a nice idea to share some of my experience with the new regulation with you. Stop – step back When the regulation was published in the OJ I wrote that it was a big disappointment […]
The end of the year is upon us, and I’d like to take the opportunity to wish the readers of this blog all the best for the new year, a new year with lots of exciting developments ahead. This post will not be the usual regulatory and legal analysis of rules, but something more forward […]
Today was a big day with a half hour press conference by Commissioner Dalli (for Twitter summaries see here and here) to festively launch the two much anticipated EU medical devices regulation proposals (one for general medical devices, including active implantables, and one for IVDs). The generalities of the proposals, as you can read in the press release and the Commission’s communication on the subject, are […]
Our seminar on IVD legal and regulatory issues of 12 september was a big succes. We had the passionate story of Henk Viëtor about Skyline Diagnostics’ efforts to bring its products to the market and presentations of my partner Carine van den Brink about marketing, advertising and online sales of IVDs and me about software […]
While everybody is starting up again after the summer and had 26 September as first major horizon date in their head (the date on which the Commission has said it will publish the proposed new EU medical devices rules), the EU decided to go ahead and change the rules for (active) medical devices utilising tissues […]
In my previous post on this topic I wrote that it looked like the Commission had changed tack to propose a pre-market authorisation (PMA) for medical devices after all. It turns out that I had drawn that conclusion prematurely. This post serves to update and correct the picture. As more information became available after the hearing […]
Some time ago I wrote about the proposed ENVI resolution that the the EU Parliament’s ENVI committee adopted in reaction to the PIP breast implants scandal in the EU. At that time the final text was not out because the EU Parliament still had to vote on it. Now it has and the adopted resolution does […]