Regulation (EU) 2023/607 of the European Parliament and of the Council of 15 March 2023 amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards the transitional provisions for certain medical devices and in vitro diagnostic medical devicesText with EEA relevance.

Article 120(3d)..

Article 2

Amendments to Regulation (EU) 2017/746

Regulation (EU) 2017/746 is amended as follows:

(1) in Article 110, paragraph 4 is replaced by the following:

1. Devices lawfully placed on the market pursuant to Directive 98/79/EC prior to 26 May 2022, and devices lawfully placed on the market from 26 May 2022 pursuant to paragraph 3 of this Article may continue to be made available on the market or put into service.

;

(2) in Article 112, the second paragraph is replaced by the following:

As regards the devices referred to in Article 110(3) and (4) of this Regulation, Directive 98/79/EC shall continue to apply to the extent necessary for the application of those paragraphs..

Article 3

Entry into force

This Regulation shall enter into force on the day of its publication in the Official Journal of the European Union.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Strasbourg, 15 March 2023.

For the European Parliament

The President

R. Metsola

For the Council

The President

J. Roswall