Decision of the EEA Joint Committee No 48/2023 of 17 March 2023 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2331]
Date: 2023-03-17
Institutions: EEA Joint Committee
Subjects: EC conformity marking, European Economic Area, clinical trial, market approval, marketing standard, medical device, product safety, revision of an agreement, risk management, technical specification




L_202302331EN.000101.fmx.xml












Official Journal of the European Union


EN
Series L













2023/2331


26.10.2023







            DECISION OF THE EEA JOINT COMMITTEE No 48/2023
of 17 March 2023
         
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2023/2331]


THE EEA JOINT COMMITTEE,

Having regard to the Agreement on the European Economic Area (“the EEA Agreement”), and in particular Article 98 thereof,

Whereas:







(1)


Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (1) is to be incorporated into the EEA Agreement.












(2)


Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (2) is to be incorporated into the EEA Agreement.












(3)


Annex II to the EEA Agreement should therefore be amended accordingly,





HAS ADOPTED THIS DECISION:



Article 1
The following points are inserted after point 11c (Commission Implementing Regulation (EU) 2021/2078) of Chapter XXX of Annex II to the EEA Agreement:






‘11d.



32022 R 2346: Commission Implementing Regulation (EU) 2022/2346 of 1 December 2022 laying down common specifications for the groups of products without an intended medical purpose listed in Annex XVI to Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices (OJ L 311, 2.12.2022, p. 60).










11e.



32022 R 2347: Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (OJ L 311, 2.12.2022, p. 94).’






Article 2
The texts of Implementing Regulations (EU) 2022/2346 and (EU) 2022/2347 in the Icelandic and Norwegian languages, to be published in the EEA Supplement to the Official Journal of the European Union, shall be authentic.


Article 3
This Decision shall enter into force on 18 March 2023, provided that all the notifications under Article 103(1) of the EEA Agreement have been made (*1).


Article 4
This Decision shall be published in the EEA Section of, and in the EEA Supplement to, the Official Journal of the European Union.




Done at Brussels, 17 March 2023.


For the EEA Joint Committee


The President

Nicolas VON LINGEN
            





(1)  
            OJ L 311, 2.12.2022, p. 60.

(2)  
            OJ L 311, 2.12.2022, p. 94.

(*1)  No constitutional requirements indicated.


ELI: http://data.europa.eu/eli/dec/2023/2331/oj
ISSN 1977-0677 (electronic edition)