Regulation 2017/745 will fully apply from 26 May 2020. Hence, from 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 current legislative framework to be placed on the market at the latest until 26 May 2024.
By when do self-care medical devices need to comply with Regulation 2017/745?
| Alix Marchal