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Erik Vollebregt
Just before Christmas the European Court rendered a judgment that is important for medical devices companies that have devices that run software and have a graphic user interface (GUI). The case concerned…
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Erik Vollebregt
Many medical devices companies have invested in making their marketing actvities aimed at healthcare professionals Eucomed Code of Ethical Business Practices compliant. Although the Eucomed code has a lot of authority in…
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Erik Vollebregt
The European Commission has revised its rules for the assessment of co-operation agreements between competitors, so called horizontal co-operation agreements. The most important changes for the medical devices industry are in the…
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Erik Vollebregt
Convergence is all around us. The traditionally well defined different groups of medical devices, medicinal products and biotechnology products are more and more moving closer and closer together to form a genuine…
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Erik Vollebregt
Just before the holidays the Commission has issued guidelines on an issue that suffers a lot from the lack of harmonisation in the EU: clinical investigation for medical devices. Now that the…
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Erik Vollebregt
I often run into questions that are a mixture of problems relating to parallel imports of medical devices, repackaging/relabelling, trademark law and internet sales. Obviously, manufacturers do not like it when another…
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Erik Vollebregt
EU member states are not under all circumstances allowed to restrict the sale of OTC medical devices only brick-and-mortar shops which specialise in medical devices. That is the outcome of the recent…
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Erik Vollebregt
That is the question. It is in fact on of the core questions of the three medical devices directives (the Medical Devices Directive, the In Vitro Diagnostics Directive and the Active Implantable…
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Erik Vollebregt
In a press release of 24 November 2010 the European Commission announced that the European Parliament has voted to revise the RoHS directive (EU legislation on the use of hazardous substances in electrical…