product liability

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European Court of Justice introduces 'product batch' liability

This blog has discussed product liability cases in relation to the EU Product Liability Directive before (for example here and here). Now there is another product liability case recently decided by the European Court of Justice,…

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ENVI's amendments

ENVI’s amendments, following those of IMCO  have been published now after translation, see here for IVDs and here for medical devices. This accounts for the biggest load of the amendments (297 –…

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EU court rules on no-fault liability for medical services with medical devices

The judgment in the Centre hospitalier universitaire de Besançon v Thomas Dutrueux, Caisse primaire d’assurance maladie du Jura case that I wrote about earlier has been handed down by the EU Court on…

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Developments in EU product liability for medical devices – or not

Now here is an important case for the medical devices industry. Although product liability litigation has not (yet) evolved into the type of bet the company litigation it can be in the…

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Mind the reminder for Medical Devices and M&A seminar

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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Software as medical device – regulatory requirements, product liability

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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Reprocessing of single use medical devices in the EU

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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