2021/0307/P
EC/EFTA
PT Portugal
  • S10S - Medical devices
2021-08-26
2021-06-01

Medical devices, medical device accessories and non-medical products listed in Annex XVI to Regulation (EU) 2017/745.

Ensure the transposition into national law of Regulation (EU) 2017/745 of the Parliament and of the Council of 5 April 2017 as amended by Regulation (EU) 2020/561 of the Parliament and of the Council of 23 April as regards the clinical investigation of devices and Regulation (EU) 2017/746 of the Parliament and of the Council of 5 April 2017 as regards the performance study of medical devices for in vitro diagnosis

The purpose of the draft law is to ensure transposition in national law of Regulation (EU) 2017/745 of the Parliament and of the Council of 5 April 2017 as amended by Regulation (EU) 2020/561 of the Parliament and of the Council of 23 April as regards the clinical investigation of devices, and Regulation (EU) 2017/746 of the Parliament and of the Council of 5 April 2017 as regards the performance study of medical devices for in vitro diagnosis.

In order to lay down in a single law the implementing rules for two Regulations, and giving continuity to the measures already adopted or to be adopted under Regulations (EU) 2017/745 and 2017/746 including through the respective implementing acts, the proposal for a Law designates the competent authorities and clarifies their powers by laying down additional measures, in particular on the matter of the protection of participants and informed consent, as well as the penalty framework applicable to infringements.

Key words: device, clinical research, performance study