Decision of the EEA Joint Committee No 218/2015 of 25 September 2015 amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2017/525]
Date: 2015-09-25
Institutions: EEA Joint Committee
Subjects: EC conformity marking, European Economic Area, health control, medical device, product safety, quality control of industrial products, revision of an agreement, technological change, traceability




L_2017085EN.01003901.xml










30.3.2017   


EN


Official Journal of the European Union


L 85/39








            DECISION OF THE EEA JOINT COMMITTEE
         
No 218/2015
of 25 September 2015
         
amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement [2017/525]


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) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (1) is to be incorporated into the EEA Agreement.












(2)


Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (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
Chapter XXX of Annex II to the EEA Agreement shall be amended as follows:






1.


The following point is inserted after point 9 (Commission Regulation (EU) No 207/2012):






‘10.



32013 R 0920: Commission Implementing Regulation (EU) No 920/2013 of 24 September 2013 on the designation and the supervision of notified bodies under Council Directive 90/385/EEC on active implantable medical devices and Council Directive 93/42/EEC on medical devices (OJ L 253, 25.9.2013, p. 8).’














2.


The following point is inserted after point 1 (Commission Recommendation 2013/172/EU) under the heading ‘ACTS OF WHICH THE CONTRACTING PARTIES SHALL TAKE NOTE’:






‘2.



32013 H 0473: Commission Recommendation 2013/473/EU of 24 September 2013 on the audits and assessments performed by notified bodies in the field of medical devices (OJ L 253, 25.9.2013, p. 27).’










Article 2
The texts of Implementing Regulation (EU) No 920/2013 and Recommendation 2013/473/EU 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 26 September 2015, 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, 25 September 2015.


For the EEA Joint Committee


The President

Ingrid SCHULERUD
            





(1)  
            OJ L 253, 25.9.2013, p. 8.

(2)  
            OJ L 253, 25.9.2013, p. 27.

(*1)  No constitutional requirements indicated.