The Commission proposes important changes regarding various aspects relevant for the life-cycle of medical devices, such as the scope of the legislation, the pre-market assessment of devices, their control once on the market, the transparency of data concerning marketed devices and the management of the regulatory system by the authorities.
Kavas on muuta õigusaktide kohaldamisala, seadmete turustamiseelset hindamist, turustamisjärgset kontrolli, andmete läbipaistvust müügiolevate seadmete kohta ning õigussüsteemi haldamist ametiasutuste poolt.