Basic Information about the European Directive 93/42/EEC on ...
Basic Information about the European Directive 93/42/EEC on ...
Basic Information about the European Directive 93/42/EEC on ...
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<str<strong>on</strong>g>Basic</str<strong>on</strong>g> <str<strong>on</strong>g>Informati<strong>on</strong></str<strong>on</strong>g> MDD <str<strong>on</strong>g>93</str<strong>on</strong>g>/<str<strong>on</strong>g>42</str<strong>on</strong>g>/<str<strong>on</strong>g>EEC</str<strong>on</strong>g><br />
II. C<strong>on</strong>formity Assessment Procedures – (Annexes II to VII)<br />
Class I<br />
n<strong>on</strong>-sterile and<br />
no measuring<br />
functi<strong>on</strong><br />
Annex VII<br />
Technical<br />
Documentati<strong>on</strong><br />
Declarati<strong>on</strong> of<br />
C<strong>on</strong>formity and<br />
display of CE<br />
Annex II.<br />
1 – 3, 5<br />
Full Quality<br />
Assurance<br />
System<br />
*Annex IV<br />
EC-<br />
Verificati<strong>on</strong><br />
(not by sterile<br />
products)<br />
Class I<br />
sterile and/or with<br />
measuring functi<strong>on</strong><br />
Annex VII<br />
Technical<br />
Documentati<strong>on</strong><br />
*Annex V<br />
Procucti<strong>on</strong><br />
Quality<br />
Assurance<br />
*Annex VI<br />
Product<br />
Quality<br />
Assurance<br />
(not by sterile<br />
products)<br />
Declarati<strong>on</strong> of C<strong>on</strong>formity and display of CE 0483<br />
*<strong>on</strong>ly referring to sterility/metrologic functi<strong>on</strong><br />
Annex IV<br />
EC-<br />
Verificati<strong>on</strong><br />
Class IIa<br />
Annex VII<br />
Technical Documentati<strong>on</strong><br />
Annex V<br />
Producti<strong>on</strong><br />
Quality<br />
Assurance<br />
Declarati<strong>on</strong> of C<strong>on</strong>formity and display of CE 0483<br />
*Annex II.<br />
1 – 3, 5<br />
Full Quality<br />
Assurance<br />
System<br />
Annex VI<br />
Product<br />
Quality<br />
Assurance<br />
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