Medische Apps niet zonder gevaar
Het toenemend gebruik van medische apps door zorgprofessionals kan de patiëntenzorg verbeteren, maar heeft ook potentiële gevaren. Regels en protocollen ontbreken nog. Lees meer …
Het toenemend gebruik van medische apps door zorgprofessionals kan de patiëntenzorg verbeteren, maar heeft ook potentiële gevaren. Regels en protocollen ontbreken nog. Lees meer …
“S is for scrutiny, which we’re not sure about”, that would be more or less the take home message of the MedTech Forum in Brussels that I attended last week from Wednesday to Friday. This conference is an ideal moment to take stock of the EU medtech industry. No wonder that everyone was there to […]
Wednesday 14 November Medical Devices SeminarAxon organizes a seminar addressing the new medical devices proposalProgram and invitation …
Dear readers, while I am working on the promised blog posts on parts of the new regulation proposal for medical devices, I would like to let you know about the two and a half hour afternoon seminar that my firm will organise this 14 November in cooperation with Philips Healthcare and the Qserve Group. As […]
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 […]
Recent decisions on Health ClaimsBy 14 December 2012, food items in the European Union (EU) with a health claim on their packaging read more …
Axon Seminar In Vitro DiagnosticsPresentations can be downloaded by clicking on the titles:Practical aspects by Henk Viëtor, Skyline DiagnosticsFuture regulation by Sabine Ohse, BSIPromotion and Sale by Carine van den Brink, Axon LawyersSoftware …
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 […]
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 […]
Dear readers, I hope you don’t mind some modest self-promotion: my firm is organising a seminar on EU recent (and future) legal and regulatory developments with respect to in vitro diagnostics, with very interesting external speakers. The seminar is free and you are welcome to attend with as many colleagues as you like (just make […]