d1e638-1-1__para__9
Furthermore, Article 2(4)(g) of Directive 2012/19/EU excludes from its scope ‘medical devices and in vitro diagnostic medical devices, where such devices are expected to be infective prior to end of life, and active implantable medical devices’. Therefore, those devices should also be understood as relevant for derogation from the requirements in Article 11(1) of Regulation 2023/1542.
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Source: EUR-Lex (Cellar) · retrieved 2026-09-07 · Text as adopted (Official Journal); later amendments are not incorporated in this text.