MedTech Europe Response to the Inception Impact Assessment – Product Liability Directive

Posted on 06.08.2021

MedTech Europe, the European trade association for the medical technology industry including diagnostics, medical devices and digital health welcomes the opportunity to provide comments on behalf of the medical technology industry to the European Commission on the Inception Impact Assessment regarding the revision of the Product Liability Framework.

As previously shared with the European Commission, MedTech Europe supports the baseline scenario. However, should this not be an option, MedTech Europe would support also developing policy option 2.1.a.

MedTech Europe supports, in certain specific cases, the alleviation of the burden of proof and recognises that this is something that is already happening in some Member States. Such an alleviation of the burden of proof by allowing courts to infer that a product is defective or caused the damage under certain circumstances, e.g. when other products in the same production series have already been proven to be defective or when a product clearly malfunctions, is a concept that was already applied by courts to different products and different situations in order to properly balance public interest and expectations of safety.

On the other hand, MedTech Europe does not support the remaining policy options, as (i) they don’t allow to take full advantage of the impact and benefits of AI in the healthcare sector for patients, healthcare professionals and healthcare systems, or ,(ii) regarding the option to broaden the scope, MedTech Europe believes that in many cases it is not necessary as there are already existing regulations applying to medical technologies (or medtech) products by which those cases/aspects are covered/addressed and enable victims to take recourse.

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