P9_TA(2023)0052 Transitional provisions for certain medical devices and in vitro diagnostic medical devices European Parliament legislative resolution of 16 February 2023 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010 — C9-0003/2023 — 2023/0005(COD)) P9_TC1-COD(2023)0005 Position of the European Parliament adopted at first reading on 16 February 2023 with a view to the adoption of Regulation (EU) 2023/… of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices
Date: 2023-02-16
Institutions: Committee on Employment and Social Affairs, Committee on the Environment, Climate and Food Safety, Committee on the Internal Market and Consumer Protection, European Parliament
Subjects: EC conformity marking, market approval, marketing standard, medical device, medical diagnosis, public health, quality standard, safety standard, security of supply, single market








C_2023283EN.01016301.xml










11.8.2023   


EN


Official Journal of the European Union


C 283/163






P9_TA(2023)0052
Transitional provisions for certain medical devices and in vitro diagnostic medical devices
European Parliament legislative resolution of 16 February 2023 on the proposal for a regulation of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices (COM(2023)0010 — C9-0003/2023 — 2023/0005(COD))
(Ordinary legislative procedure: first reading)
(2023/C 283/30)

The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2023)0010),










—


having regard to Article 294(2) and Article 114 and Article 168(4), point (c), of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0003/2023),










—


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










—


having regard to the opinion of the European Economic and Social Committee of 24 January 2023 (1),










—


after consulting the Committee of the Regions,










—


having regard to the undertaking given by the Council representative by letter of 1 February 2023 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.






(1)  Not yet published in the Official Journal.




P9_TC1-COD(2023)0005
Position of the European Parliament adopted at first reading on 16 February 2023 with a view to the adoption of Regulation (EU) 2023/… of the European Parliament and of the Council amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devices

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2023/607.)