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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...
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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 United States...
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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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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 – 907 on...
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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...
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Product liability for devices under MDR and IVDR
With the MDR and IVDR nearing completion in the trilogue negotiations the final outline of these two statutes become more and more clear. It looks now like the regulations will be agreed upon during...
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EU Court decides TÜV Rheinland / PIP breast implants case
It has been sort of hanging over the medical devices market for quite a long time: the TÜV Rheinland case about the PIP breast implants. This case is the direct result of the PIP breast implants...
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Counting down to the MDR date of application, and the legal stuff to get...
Do you know that feeling that things look far away, but when you think about it are a lot closer than you think? This is the feeling that the first medical devices companies are having because are...
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The New Product Liability Directive(s) proposals and medical devices / IVDs
On 28 September the Commission adopted two related proposals for EU regulation of no-fault liability for defective products. One proposal updates the ‘old’ Product Liability Directive (PLD) from 1985...
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