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 />
Annexes II – VII of <str<strong>on</strong>g>the</str<strong>on</strong>g> Medical Devices <str<strong>on</strong>g>Directive</str<strong>on</strong>g> <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> (MDD)<br />
Annex II – EC Declarati<strong>on</strong> of C<strong>on</strong>formity (Full Quality Assurance System):<br />
Most comprehensive c<strong>on</strong>formity assessment procedure referring to a full quality system including <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
design phase for new devices or changes of existing devices; Secti<strong>on</strong> 4 (Examinati<strong>on</strong> of <str<strong>on</strong>g>the</str<strong>on</strong>g> Design of<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> Product) applies <strong>on</strong>ly to class III devices; this Secti<strong>on</strong> is similar to Annex III - EC Type-Examinati<strong>on</strong><br />
with <str<strong>on</strong>g>the</str<strong>on</strong>g> difference that in-house test results obtained by <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer under his full quality<br />
management system may be used as <str<strong>on</strong>g>the</str<strong>on</strong>g> basis of certificati<strong>on</strong>; <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer may choose <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
harm<strong>on</strong>ized standard EN ISO 13485 in combinati<strong>on</strong> with <str<strong>on</strong>g>the</str<strong>on</strong>g> respective guidance standard as <str<strong>on</strong>g>the</str<strong>on</strong>g> basis<br />
of his quality system or use an equivalent quality system suitable to fulfill <str<strong>on</strong>g>the</str<strong>on</strong>g> requirements of <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD.<br />
Annex III - EC Type Examinati<strong>on</strong>:<br />
A c<strong>on</strong>formity assessment procedure for <str<strong>on</strong>g>the</str<strong>on</strong>g> product design which involves examinati<strong>on</strong> and third party<br />
testing of representative samples of <str<strong>on</strong>g>the</str<strong>on</strong>g> device and certificati<strong>on</strong> that <str<strong>on</strong>g>the</str<strong>on</strong>g> device meets <str<strong>on</strong>g>the</str<strong>on</strong>g> applicable<br />
essential requirements of <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD; EC Type Examinati<strong>on</strong> is applicable <strong>on</strong>ly to class IIb and III devices.<br />
Annex IV - EC Verificati<strong>on</strong>:<br />
A c<strong>on</strong>formity assessment procedure in which <str<strong>on</strong>g>the</str<strong>on</strong>g> Notified Body examines and tests every individual<br />
device or devices taken <strong>on</strong> a statistical basis, if <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer manufactures homogeneous batches;<br />
<str<strong>on</strong>g>the</str<strong>on</strong>g> Notified Body releases individual devices or batches; EC Verificati<strong>on</strong> may be applied to class IIa, IIb<br />
and III devices.<br />
Annex V - EC Declarati<strong>on</strong> of C<strong>on</strong>formity (Producti<strong>on</strong> Quality Assurance): A c<strong>on</strong>formity assessment<br />
procedure for <str<strong>on</strong>g>the</str<strong>on</strong>g> quality system of <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer excluding <str<strong>on</strong>g>the</str<strong>on</strong>g> design phase of new devices but<br />
including all o<str<strong>on</strong>g>the</str<strong>on</strong>g>r aspects of c<strong>on</strong>formity with <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD; this c<strong>on</strong>formity assessment procedure is <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
most suitable procedure for sterile class IIa devices, if <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer does not choose <str<strong>on</strong>g>the</str<strong>on</strong>g> Annex II<br />
as <str<strong>on</strong>g>the</str<strong>on</strong>g> basis of certificati<strong>on</strong>; it may also be applied to class IIb and III devices in combinati<strong>on</strong> with Annex<br />
III; <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer may base his quality system <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> harm<strong>on</strong>ized standard EN ISO 13485.<br />
Annex VI - EC Declarati<strong>on</strong> of C<strong>on</strong>formity (Product Quality Assurance): A c<strong>on</strong>formity assessment<br />
procedure for <str<strong>on</strong>g>the</str<strong>on</strong>g> quality system for manufacturers of devices whose relevant properties can be<br />
assessed in final inspecti<strong>on</strong>; <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturer may base his quality system <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> standard EN ISO<br />
13485; this c<strong>on</strong>formity assessment procedure is not suitable for devices involving special<br />
manufacturing processes requiring validati<strong>on</strong>, like sterilizati<strong>on</strong>; Annex VI may not be used for <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
assessment of class III products.<br />
Annex VII - EC Declarati<strong>on</strong> of C<strong>on</strong>formity: A c<strong>on</strong>formity assessment procedure in which <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
manufacturer himself declares <str<strong>on</strong>g>the</str<strong>on</strong>g> compliance of his devices with <str<strong>on</strong>g>the</str<strong>on</strong>g> MDD; suitable for class I devices,<br />
and required for class IIa devices in combinati<strong>on</strong> with <strong>on</strong>e of <str<strong>on</strong>g>the</str<strong>on</strong>g> Annexes IV, V, or VI.<br />
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