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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…
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Erik Vollebregt
With the US authorities announcing that the pharmaceuticals and medical devices industries are squarely in the bullseye of FCPA enforcement and the UK Anti-Bribery Act‘s entry into force around the corner (April…
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Erik Vollebregt
REACH has been a dot on the horizon for some companies, while others have undertaken big investments in outcomplying others. In any event, I see in practice that companies have different senses…
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Erik Vollebregt
Last Friday 12 November 2010 I read the analysis item “Sluggish medical device sector ripe for mergers” on Reuters and a more elaborate version of that article on Yahoo. The articles signal…