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 to make it suitable again for the current circumstances. The other proposal provides a complimentary directive for liability specifically for damage caused by AI. You can […]
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 facing the reality that they might not be in time any more to have a valid CE mark […]
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 scandal, which had a profound influence on the new EU MDR in the making. We had the Advocate General’s opinion […]
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 this Presidency, which means they could be published in the Official Journal and enter into force this autumn. I’m referring to […]
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, which can have big consequences for manufacturers of medical devices in the EU. This case is about pacemakers and ICDs specifically. A summary from […]
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 medical devices and 75 – 399 on IVDs), but here is a list of the things that I found particularly interesting. […]