Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices companies are having because are facing the reality that they might not be in time any more to have a valid CE mark […]
On 16 July I had the honor to give a lecture about Legal and Regulatory Aspects of 3D Printing (and biofabricaton) in the Focus on Life Sciences Summerschool program of University Medical Centre Utrecht, the Netherlands university hospital that made the headlines with a complete cranial replacement that was 3D printed. Partly old, partly new The […]
Lately I have thought a lot about future-proofing of the new EU regulation proposals for medical devices and IVDs, specifically with respect to the development of 3D printing of individualized (custom) medical devices – which is well on its way with more and more companies joining the fray. With companies like Siemens and GE investing […]
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 […]