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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NOTIFIED BODIES<br />
<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 />
The <str<strong>on</strong>g>European</str<strong>on</strong>g> new approach directives require <str<strong>on</strong>g>the</str<strong>on</strong>g> involvement of third parties in <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>formity<br />
assessment of certain products. Traditi<strong>on</strong>ally <str<strong>on</strong>g>the</str<strong>on</strong>g>se third parties had been nati<strong>on</strong>al authorities of <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
Member States. However, some Member States had gained good experience in delegating technical<br />
work to n<strong>on</strong>-governmental entities. These n<strong>on</strong>-governmental entities were unknown to some Member<br />
States and to <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>European</str<strong>on</strong>g> Commissi<strong>on</strong>. As <str<strong>on</strong>g>the</str<strong>on</strong>g>re were no uniform criteria for <str<strong>on</strong>g>the</str<strong>on</strong>g> designati<strong>on</strong> of such<br />
entities, <str<strong>on</strong>g>the</str<strong>on</strong>g> development of <str<strong>on</strong>g>European</str<strong>on</strong>g> legislati<strong>on</strong> was relatively difficult.<br />
The new approach reoriented EU legislative policy <strong>on</strong> such matters as technical competence,<br />
objectivity and transparency as <str<strong>on</strong>g>the</str<strong>on</strong>g> foundati<strong>on</strong>s for <str<strong>on</strong>g>the</str<strong>on</strong>g> necessary degree of trust in <str<strong>on</strong>g>the</str<strong>on</strong>g> system, <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
basis of documented technical criteria enshrined in <str<strong>on</strong>g>the</str<strong>on</strong>g> legislati<strong>on</strong> itself and in <str<strong>on</strong>g>the</str<strong>on</strong>g> appropriate<br />
<str<strong>on</strong>g>European</str<strong>on</strong>g> standards. Member States are invited under all new approach directives to notify <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
Commissi<strong>on</strong> of those bodies which <str<strong>on</strong>g>the</str<strong>on</strong>g>y c<strong>on</strong>sider competent to undertake <str<strong>on</strong>g>the</str<strong>on</strong>g> resp<strong>on</strong>sibilities of Notified<br />
Bodies. A clear distincti<strong>on</strong> shall be made at <str<strong>on</strong>g>the</str<strong>on</strong>g> nati<strong>on</strong>al level between <str<strong>on</strong>g>the</str<strong>on</strong>g> Notified Bodies who<br />
intervene in <str<strong>on</strong>g>the</str<strong>on</strong>g> pre-market c<strong>on</strong>formity assessment procedures and <str<strong>on</strong>g>the</str<strong>on</strong>g> nati<strong>on</strong>al public authorities<br />
(nati<strong>on</strong>al, regi<strong>on</strong>al or local) resp<strong>on</strong>sible for <str<strong>on</strong>g>the</str<strong>on</strong>g> market surveillance imposed by <str<strong>on</strong>g>the</str<strong>on</strong>g> directives for<br />
products <strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> market.<br />
Notified Bodies are free to offer <str<strong>on</strong>g>the</str<strong>on</strong>g>ir c<strong>on</strong>formity assessment services for which <str<strong>on</strong>g>the</str<strong>on</strong>g>y are notified to any<br />
manufacturer established ei<str<strong>on</strong>g>the</str<strong>on</strong>g>r inside <str<strong>on</strong>g>the</str<strong>on</strong>g> EU or in third countries. They may carry out <str<strong>on</strong>g>the</str<strong>on</strong>g>se activities<br />
<strong>on</strong> <str<strong>on</strong>g>the</str<strong>on</strong>g> territory of o<str<strong>on</strong>g>the</str<strong>on</strong>g>r countries ei<str<strong>on</strong>g>the</str<strong>on</strong>g>r with <str<strong>on</strong>g>the</str<strong>on</strong>g>ir own pers<strong>on</strong>nel or with subc<strong>on</strong>tractors.<br />
At <str<strong>on</strong>g>the</str<strong>on</strong>g> time of <str<strong>on</strong>g>the</str<strong>on</strong>g> first notificati<strong>on</strong> with respect to a new approach directive <str<strong>on</strong>g>the</str<strong>on</strong>g> EU Commissi<strong>on</strong> assigns<br />
a four digit identificati<strong>on</strong> number to <str<strong>on</strong>g>the</str<strong>on</strong>g> Notified Body. This number will not change when <str<strong>on</strong>g>the</str<strong>on</strong>g> same<br />
Notified Body is notified for o<str<strong>on</strong>g>the</str<strong>on</strong>g>r directives at a later stage.<br />
Notified Bodies are under surveillance by <str<strong>on</strong>g>the</str<strong>on</strong>g>ir nati<strong>on</strong>al notifying authorities which have <str<strong>on</strong>g>the</str<strong>on</strong>g> authority to<br />
withdraw or modify <str<strong>on</strong>g>the</str<strong>on</strong>g> notificati<strong>on</strong> as so<strong>on</strong> as <str<strong>on</strong>g>the</str<strong>on</strong>g> c<strong>on</strong>diti<strong>on</strong>s of notificati<strong>on</strong> are no l<strong>on</strong>ger met.<br />
Notified Bodies are and must remain third parties, independent of <str<strong>on</strong>g>the</str<strong>on</strong>g>ir clients and o<str<strong>on</strong>g>the</str<strong>on</strong>g>r interested<br />
parties.<br />
With respect to <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>European</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> Notified Bodies are entitled to<br />
perform product as well as quality system management related c<strong>on</strong>formity assessment procedures as<br />
outlined in Article 11 and <str<strong>on</strong>g>the</str<strong>on</strong>g> Annexes II, III, IV, V, VI and VII of this directive. Notified Bodies may have<br />
a limited scope with respect to <str<strong>on</strong>g>the</str<strong>on</strong>g> device families and/or <str<strong>on</strong>g>the</str<strong>on</strong>g> Annexes for which <str<strong>on</strong>g>the</str<strong>on</strong>g>y are notified.<br />
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