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Erik Vollebregt
At the International Medical Device Industry Compliance Conference today nine medical devices branch associations from around the world committed to further advance ethical behaviour globally by signing the “Global Compliance Statement on…
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Erik Vollebregt
It’s finally public: the Code of Conduct for Notified Bodies under Directives 90/385/EEC and 93/42/EEC “Improving implementation of the European CE certification of medical devices through harmonization of quality and competence of…
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Erik Vollebregt
Advertising and marketing of medical devices is a subject I see many clients struggle with. Unlike with medicinal products EU law in the field of advertising and marketing is almost not harmonised….
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Erik Vollebregt
The European Database on Medical Devices (Eudamed) is now finally upon us. As per article 6 of the Commission Decision establishing the Eudamed database, EU member states must apply the decision as of…
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Erik Vollebregt
On Wednesday 13 April I organised a seminar and realtime webinar at my firm about M&A in the medical devices sector, to discuss the legal and regulatory implications of an M&A project…
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Erik Vollebregt
Last Wednesday 13 April I spoke at Informa’s 6th Annual Clinical Evaluations and Investigations for Medical Devices conference about legal aspects of outsourced clinical investigation in the medical devices industry. Proceeding from showing…
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Erik Vollebregt
I know, nobody likes reminders. But this one is for a good cause: our free seminar / webinar about M&A in the medical devices sector this Wednesday 13 April in the afternoon. …
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Erik Vollebregt
Today I attended the NEN (Nederlands Normalisatie instituut (Dutch Standardisation Institute)) meeting about “Software and the MDD”, where I presented about recent developments in software and the MDD (apologies to the English…
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Erik Vollebregt
Traditionally the borderlines between different categories of regulated products (medicinal products, medical devices, food, cosmetics, etc.) have been looked at as strict lines. More and more however it becomes evident that although…