P9_TA(2020)0053 Medical devices ***I European Parliament legislative resolution of 17 April 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (COM(2020)0144 — C9-0098/2020 — 2020/0060(COD)) P9_TC1-COD(2020)0060 Position of the European Parliament adopted at first reading on 17 April 2020 with a view to the adoption of Regulation (EU) 2020/… of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions
Date: 2020-04-17
Institutions: Committee on the Environment, Climate and Food Safety, European Parliament
Subjects: EC conformity marking, coronavirus disease, epidemic, harmonisation of standards, health legislation, market approval, medical device, quality label, quality standard, safety standard








C_2021316EN.01002901.xml










6.8.2021   


EN


Official Journal of the European Union


C 316/29






P9_TA(2020)0053
Medical devices ***I
European Parliament legislative resolution of 17 April 2020 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices as regards the dates of application of certain of its provisions (COM(2020)0144 — C9-0098/2020 — 2020/0060(COD))
(Ordinary legislative procedure: first reading)
(2021/C 316/15)

The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2020)0144),










—


having regard to Article 294(2) and Articles 114 and 168(4)(c) of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0098/2020),










—


having regard to Article 294(3) of the Treaty on the Functioning of the European Union,










—


after consulting the European Economic and Social Committee,










—


after consulting the Committee of the Regions,










—


having regard to the undertaking given by the Council representative by letter of 8 April 2020 to approve Parliament’s position, in accordance with Article 294(4) of the Treaty on the Functioning of the European Union,










—


having regard to Rules 59 and 163 of its Rules of Procedure,












1.


Adopts its position at first reading hereinafter set out;












2.


Calls on the Commission to refer the matter to Parliament again if it replaces, substantially amends or intends to substantially amend its proposal;












3.


Instructs its President to forward its position to the Council, the Commission and the national parliaments.








P9_TC1-COD(2020)0060
Position of the European Parliament adopted at first reading on 17 April 2020 with a view to the adoption of Regulation (EU) 2020/… of the European Parliament and of the Council amending Regulation (EU) 2017/745 on medical devices, as regards the dates of application of certain of its provisions

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2020/561.)