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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…
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Erik Vollebregt
I attended an interesting seminar today about software as medical device organised by NEN, the Dutch standardisation institute. Speakers at the seminar highlighted the different views on this subject from the perspective…
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Erik Vollebregt
On 28 April 2010 the European Commission published the SCENHIR’s opinion on reprocessing of medical devices, which was adopted by the SCENHIR on 15 April 2010. This opinion was commissioned pursuant to…
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Erik Vollebregt
People have been asking me for copies of my presentation “From Bench to Bedside” about legal and regulatory aspects of bringing a newly developed in vitro diagnostic device to the market that I…
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Erik Vollebregt
In a judgment of 20 September 2010 the The Hague District Court ruled that it was OK for AED that are CE marked to not be accompanied by paper instructions for use…