What are the changes introduced by Regulation 2017/745 concerning self-care medical devices?

Apart from general changes that affect all types of medical devices, such as improved transparency through a comprehensive EU database on medical devices and a device traceability system based on unique device identification or strengthening of post-market surveillance requirements for manufacturers, Regulation 2017/745 expressly recognizes substance-based medical devices. In particular, classification rule 21 addresses specifically medical devices composed of substances or of combinations of substances.

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