A nice repack, with some additional little gems. That’s how I would describe the recently released MHRA guidance on standalone software as a medical device. The guidance of course has to color between the lines of the existing MEDDEV on standalone software (which itself is under revision currently but seems to have been bogged down considerably […]
The EU market for medical devices is not fully harmonized, which means that you cannot rely on a medical device being a medical device everywhere in the EU. That, essentially, is what the European Court’s recent judgment in the Lycocentre case confirms. Confirms? Yes, it basically confirms what we already knew and that is that […]
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 […]
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. […]
Last week the EU Court decided Brain Products / BioSemi, one of the pending borderline cases involving demarcation between medical devices and ‘general stuff’. This case is interesting and important because it concerns a direct interpretation of the definition of medical device in the EU Medical Devices Directive (MDD), which is why I have already […]
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 […]
Last Thursday the EU Court rendered judgment in the mouthwash case, C-308/11 Chemische Fabrik Kreussler vs Sunstar. The judgment immediately brought one of my favorite Yogi Berra quotes to mind: “You’ve got to be very careful if you don’t know where you are going, because you might not get there.” This statement is spot on […]
The Advocate General of the EU Court presented his conclusion today in one of the three medical devices borderline cases currently pending at the EU Court, C-219/11 Brain Products vs BioSemi. The other two are C-109/12 Lycocentre and C-308/11 Chemische Fabrik Kreussler, with respect to the latter see also here. The other two are more […]