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SOME ISSUES OF RISKY IMPLANTABLE MEDICAL DEVICES TO BE INCLUDED IN THE CONCEPT OF DEFECT UNDER THE EU DIRECTIVE 85/374 AND THE REGULATORY RESPONSE OF THE EU DIRECTIVE 2024/2853 ON PRODUCT LIABILITY
This article aims to raise some issues related to the inclusion of risky implantable medical devices in the concept of defect under Directive 85/374, which, having particular characteristics related to the risky interaction, the intended purpose of the product, the inherent risks, the potential damage they could cause, require an assessment adjusted to the particular circumstances of these products. The subject is approached from the point of view of the risky implantable medical device, its regulation from the administrative sphere and the sphere of civil liability, to finally analyse whether these issues were resolved or maintained in the new European regulation on defective products, Directive EU 2024/2853, which aims to contribute to the proper functioning of the internal market, while guaranteeing a high level of protection for consumers and other natural persons.