By when do self-care medical devices need to comply with Regulation 2017/745?

Regulation 2017/745 is applicable since May 2021. Since that date, all medical devices, including self-care medical devices, must comply with the provisions of the Regulation. However, subject to certain conditions, transitional periods allow medical devices with a certificate obtained under the previous legislative framework to be placed on the market at the latest until December 2027 or 2028, depending on the risk class of the given device.

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