P9_TA(2021)0498 Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I European Parliament legislative resolution of 15 December 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (COM(2021)0627 — C9-0381/2021 — 2021/0323(COD)) P9_TC1-COD(2021)0323 Position of the European Parliament adopted at first reading on 15 December 2021 with a view to the adoption of Regulation (EU) 2022/… of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices
Date: 2021-12-15
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, coronavirus disease, epidemic, market approval, marketing standard, medical device, medical diagnosis, public health, security of supply, single market








C_2022251EN.01022601.xml










30.6.2022   


EN


Official Journal of the European Union


C 251/226






P9_TA(2021)0498
Transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices ***I
European Parliament legislative resolution of 15 December 2021 on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices (COM(2021)0627 — C9-0381/2021 — 2021/0323(COD))
(Ordinary legislative procedure: first reading)
(2022/C 251/32)

The European Parliament,







—


having regard to the Commission proposal to Parliament and the Council (COM(2021)0627),










—


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 (C9-0381/2021),










—


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 8 December 2021 (1),










—


after consulting the Committee of the Regions,










—


having regard to the undertaking given by the Council representative by letter of 24 November 2021 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(2021)0323
Position of the European Parliament adopted at first reading on 15 December 2021 with a view to the adoption of Regulation (EU) 2022/… of the European Parliament and of the Council amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and the deferred application of conditions for in-house devices

(As an agreement was reached between Parliament and Council, Parliament's position corresponds to the final legislative act, Regulation (EU) 2022/112.)