# L_2013345EN.01001001.xml

| 19.12.2013 | EN | Official Journal of the European Union | L 345/10 |
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19.12.2013

EN

Official Journal of the European Union

L 345/10

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DECISION OF THE EEA JOINT COMMITTEE

No 141/2013

of 15 July 2013

amending Annex II (Technical regulations, standards, testing and certification) to the EEA Agreement

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 Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (1) is to be incorporated into the EEA Agreement. |
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(1)

Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (1) is to be incorporated into the EEA Agreement.

| (2) | Regulation (EU) No 722/2012 repeals, with effect from 29 August 2013, Commission Directive 2003/32/EC (2) which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement with effect from 29 August 2013. |
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(2)

Regulation (EU) No 722/2012 repeals, with effect from 29 August 2013, Commission Directive 2003/32/EC (2) which is incorporated into the EEA Agreement and which is consequently to be repealed under the EEA Agreement with effect from 29 August 2013.

| (3) | Annex II to the EEA Agreement should therefore be amended accordingly, |
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(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 5 (Commission Directive 2003/32/EC):






  ‘5a. | 32012 R 0722: Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’; |
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(1)

the following point is inserted after point 5 (Commission Directive 2003/32/EC):

‘5a.

32012 R 0722: Commission Regulation (EU) No 722/2012 of 8 August 2012 concerning particular requirements as regards the requirements laid down in Council Directives 90/385/EEC and 93/42/EEC with respect to active implantable medical devices and medical devices manufactured utilising tissues of animal origin (OJ L 212, 9.8.2012, p. 3).’;

| (2) | the text of point 5 (Commission Directive 2003/32/EC) shall be deleted with effect from 29 August 2013. |
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(2)

the text of point 5 (Commission Directive 2003/32/EC) shall be deleted with effect from 29 August 2013.

Article 2

The text of Regulation (EU) No 722/2012 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 16 July 2013, 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, 15 July 2013.

For the EEA Joint Committee

The President

Thórir IBSEN

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(1)  
  OJ L 212, 9.8.2012, p. 3.

1

(2)  
  OJ L 105, 26.4.2003, p. 18.

2

(*1)  No constitutional requirements indicated.

*1

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