EU court AG concludes in borderline case – "intended use by nature"?

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…


EU court to clarify medical device / drug borderline and the status of MEDDEV documents

Important developments for the medical devices and medicinal products industry: clarification of EU law about the borderline between these groups of products is currently in the making at the European Court of…


New EU Commission guidance on medical devices borderline products and classification

Yesterday the European Commission’s Working Group on Borderline and Classification issued the new version (1.10) of its Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices. This manual…

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