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Guide to the implementation of directives based on the New ...

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❝ <str<strong>on</strong>g>Guide</str<strong>on</strong>g> <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>implementati<strong>on</strong></str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>directives</str<strong>on</strong>g> <str<strong>on</strong>g>based</str<strong>on</strong>g> <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> <strong>New</strong> Approach and <str<strong>on</strong>g>the</str<strong>on</strong>g> Global Approach ❞<br />

Annex 3<br />

Additi<strong>on</strong>al guidance documents<br />

I<br />

Documents related <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

<strong>New</strong> Approach directive Number Date Language<br />

1. <str<strong>on</strong>g>Guide</str<strong>on</strong>g>lines <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Council<br />

Directive 73/23/EEC (electrical equipment<br />

designed for use within certain voltage limits)<br />

2. Communicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> Commissi<strong>on</strong> with regard <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> interpretative documents <str<strong>on</strong>g>of</str<strong>on</strong>g> Council Directive<br />

89/106/EEC (c<strong>on</strong>structi<strong>on</strong> products)<br />

3. The designati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> approved bodies in <str<strong>on</strong>g>the</str<strong>on</strong>g> field <str<strong>on</strong>g>of</str<strong>on</strong>g><br />

<str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>structi<strong>on</strong> products Directive<br />

OJ C 62 <str<strong>on</strong>g>of</str<strong>on</strong>g> 28/2/94<br />

Guidance paper A 11/95 EN<br />

12/97 ES, DA, DE, EL, EN,<br />

FR, IT, NL, PT, FI, SV<br />

ES, DA, DE, EL, EN,<br />

FR, IT, NL, PT<br />

4. The definiti<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> fac<str<strong>on</strong>g>to</str<strong>on</strong>g>ry producti<strong>on</strong> c<strong>on</strong>trol in<br />

technical specificati<strong>on</strong>s for c<strong>on</strong>structi<strong>on</strong> products<br />

5. The treatment <str<strong>on</strong>g>of</str<strong>on</strong>g> kits and systems under <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>structi<strong>on</strong><br />

products Directive<br />

6. CE marking under <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>structi<strong>on</strong> products<br />

Directive<br />

7. Electromagnetic compatibility EMC;<br />

<str<strong>on</strong>g>Guide</str<strong>on</strong>g> <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Directive 89/336/EEC<br />

8. Useful facts in relati<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> Directive 89/392/EEC<br />

(machinery)<br />

9. Community legislati<strong>on</strong> <strong>on</strong> machinery;<br />

comments <strong>on</strong> Directive 98/37/EC<br />

10. Pers<strong>on</strong>al protective equipment (PPE);<br />

useful facts in relati<strong>on</strong> <str<strong>on</strong>g>to</str<strong>on</strong>g> Directive 89/686/EEC<br />

Guidance paper B 5/95 EN<br />

Guidance paper C 2/97 EN<br />

Guidance paper D 12/98 EN<br />

ISBN 92-828-0762-2 12/97 DE, EN, FR<br />

ISBN 92-827-9200-5 97 EN<br />

99 ES, DE, EN, FR, IT<br />

ISBN 92-827-9199-8 97 EN<br />

11. <str<strong>on</strong>g>Guide</str<strong>on</strong>g>lines relating <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> demarcati<strong>on</strong> between<br />

Directive 90/385/EEC <strong>on</strong> active implantable<br />

medical devices, Directive 93/42/EEC <strong>on</strong> medical<br />

devices, and Directive 65/65/EEC relating <str<strong>on</strong>g>to</str<strong>on</strong>g><br />

medicinal products and related <str<strong>on</strong>g>directives</str<strong>on</strong>g><br />

Meddev. 2.1/3 –<br />

Rev. 5.1<br />

12. <str<strong>on</strong>g>Guide</str<strong>on</strong>g>lines <strong>on</strong> a medical devices vigilance system Meddev 2.12/1 –<br />

Rev. 3<br />

13. <str<strong>on</strong>g>Guide</str<strong>on</strong>g>lines <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> applicati<strong>on</strong> <str<strong>on</strong>g>of</str<strong>on</strong>g> Council Directive<br />

94/9/EC c<strong>on</strong>cerning equipment and protective<br />

systems intended for use in potentially explosive<br />

atmospheres<br />

14. Recreati<strong>on</strong>al craft Directive (94/25/EC) and<br />

comments <str<strong>on</strong>g>to</str<strong>on</strong>g> <str<strong>on</strong>g>the</str<strong>on</strong>g> Directive combined<br />

15. Handbook <strong>on</strong> <str<strong>on</strong>g>implementati<strong>on</strong></str<strong>on</strong>g> <str<strong>on</strong>g>of</str<strong>on</strong>g> C<strong>on</strong>formity Assessment<br />

Procedures relating <str<strong>on</strong>g>to</str<strong>on</strong>g> Directive 91/263/EEC<br />

(telecommunicati<strong>on</strong>s terminal equipment)<br />

3/98 EN<br />

3/98 EN<br />

99 EN<br />

6/98 EN<br />

11/95 EN<br />

74

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