INTRODUCTION
Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices and Regulation (EU) 2017/746 of the European Parliament and of the Council on in vitro diagnostic medical devices were adopted on 5 April 2017 and entered into force on 25 May 2017. Regulation (EU) 2017/745 applies since 26 May 2021. Regulation (EU) 2017/746 will apply from 26 May 2022.
Medical devices and in vitro diagnostic medical devices have a fundamental role in saving lives by providing healthcare solutions for the diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease. Regulations (EU) 2017/745 and (EU) 2017/746 aim to provide a robust, transparent and sustainable regulatory framework in order to ensure a high level of safety and performance of medical devices and in vitro diagnostic medical devices, while supporting innovation.
Regulations (EU) 2017/745 and (EU) 2017/746 empower the Commission to adopt several delegated acts. The Commission is required to report to the European Parliament and the Council on the delegations of power not later than nine months before the end of the five-year period.
LEGAL BASIS
With this report, the Commission meets the reporting requirements established in Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746. Pursuant to those provisions, the power to adopt delegated acts referred to in the provisions listed therein (i.e. Articles 1(5), 3, 10(4),18(3), 19(4), 27(10), 44(11), 52(5), 56(6), 61(8), 70(8) and 106(15) of Regulation (EU) 2017/745 and Articles 10(4), 17(4), 24(10), 51(6) and 66(8) of Regulation (EU) 2017/746), is conferred on the Commission for a period of five years from 25 May 2017.
Article 115(2) of Regulation (EU) 2017/745 and Article 108(2) of Regulation (EU) 2017/746 lay down that the delegations of power are to be tacitly extended for periods of identical duration, unless the European Parliament or the Council opposes such extension not later than three months before the end of each period.
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