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Erik Vollebregt
Since the High Level Meeting end of March where the Commission outlined its plans for the Recast of the Medical Devices Directive and took stock of the feelings about it in the…
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Erik Vollebregt
The Commission has decided that the existing mix of European and national rules are no longer adapted and need to be modernised. As IP lawyer I welcome this initiative. Although I have…
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Erik Vollebregt
Reader warning: this will be a longer-than-usual post, because I did not have time to write a short one (to cite the many philosophers and writers credited for this quote). The European…
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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…