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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mdc – NOTIFIED BODY 0483<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 />
mdc is not a newcomer in <str<strong>on</strong>g>the</str<strong>on</strong>g> medical device business. In 1994 mdc was notified by <str<strong>on</strong>g>the</str<strong>on</strong>g> German<br />
Ministry of Health (Bundesministerium für Gesundheit) 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> for c<strong>on</strong>formity<br />
assessment procedures under <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>European</str<strong>on</strong>g> Medical Device <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> as <strong>on</strong>e of <str<strong>on</strong>g>the</str<strong>on</strong>g> first<br />
German entities. The Commissi<strong>on</strong> assigned us <str<strong>on</strong>g>the</str<strong>on</strong>g> identificati<strong>on</strong> number 0483 and listed mdc as<br />
Notified Body in <str<strong>on</strong>g>the</str<strong>on</strong>g> Official Journal of <str<strong>on</strong>g>the</str<strong>on</strong>g> EC.<br />
In 2000 mdc medical device certificati<strong>on</strong> GmbH and Zertifizierungsstelle Medizinprodukte v<strong>on</strong> ZDH-<br />
ZERT e.V. (Notified Body with <str<strong>on</strong>g>the</str<strong>on</strong>g> identificati<strong>on</strong> number 0538) were c<strong>on</strong>solidated.<br />
mdc’s accreditati<strong>on</strong> scope c<strong>on</strong>tains medical devices according to MDD <str<strong>on</strong>g>93</str<strong>on</strong>g>/<str<strong>on</strong>g>42</str<strong>on</strong>g>/EWG and in vitro<br />
diagnostic devices according to IVDD 98/79/EG. This means that mdc is <strong>on</strong>e of <str<strong>on</strong>g>the</str<strong>on</strong>g> few Notified Bodies<br />
in Germany which can offer <str<strong>on</strong>g>the</str<strong>on</strong>g> manufacturers of medical devices and in vitro diagnostic devices <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
necessary certificati<strong>on</strong>s for <str<strong>on</strong>g>the</str<strong>on</strong>g> <str<strong>on</strong>g>European</str<strong>on</strong>g> market.<br />
mdc’s success is based <strong>on</strong> synergy and co-operati<strong>on</strong>. A worldwide network of representatives, cooperati<strong>on</strong><br />
partners, and most of all a high number of lead auditors and technical experts with<br />
preclinical, clinical, technical and management background in medical devices warrant <str<strong>on</strong>g>the</str<strong>on</strong>g> effective,<br />
high level service our clients can rely <strong>on</strong>.<br />
mdc shares resources with o<str<strong>on</strong>g>the</str<strong>on</strong>g>r Notified Bodies and registrars and c<strong>on</strong>tributes actively to <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
exchange of experience and informati<strong>on</strong> <strong>on</strong> a nati<strong>on</strong>al and internati<strong>on</strong>al basis. Moreover mdc’s experts<br />
serve in internati<strong>on</strong>al and <str<strong>on</strong>g>European</str<strong>on</strong>g> standards committees and working groups of <str<strong>on</strong>g>the</str<strong>on</strong>g> EU Commissi<strong>on</strong>.<br />
The Governing Board defining mdc’s certificati<strong>on</strong> policy within <str<strong>on</strong>g>the</str<strong>on</strong>g> legal framework represents am<strong>on</strong>g<br />
o<str<strong>on</strong>g>the</str<strong>on</strong>g>rs manufacturers, health professi<strong>on</strong>als and certificati<strong>on</strong> bodies.<br />
We are proud that within a short time <str<strong>on</strong>g>the</str<strong>on</strong>g> marking CE 0483 <strong>on</strong> medical devices – indicating our<br />
involvement as Notified Body – has c<strong>on</strong>tributed to <str<strong>on</strong>g>the</str<strong>on</strong>g> internati<strong>on</strong>al reputati<strong>on</strong> of our clients and <str<strong>on</strong>g>the</str<strong>on</strong>g>ir<br />
products.<br />
In <str<strong>on</strong>g>the</str<strong>on</strong>g> meantime, due to <str<strong>on</strong>g>the</str<strong>on</strong>g> competent performance we offer, mdc bel<strong>on</strong>gs to <str<strong>on</strong>g>the</str<strong>on</strong>g> group of Notified<br />
Bodies that have achieved a globally known name toge<str<strong>on</strong>g>the</str<strong>on</strong>g>r with a high reputati<strong>on</strong>. Here mdc enjoys <str<strong>on</strong>g>the</str<strong>on</strong>g><br />
flexibility of a private company that is necessary to react to <str<strong>on</strong>g>the</str<strong>on</strong>g> needs of our customers.<br />
mdc understands its task as a Notified Body to serve <str<strong>on</strong>g>the</str<strong>on</strong>g> public health as well as <str<strong>on</strong>g>the</str<strong>on</strong>g> medical device<br />
industry.<br />
040100/6 Page 18 of 20 © mdc / 2009-11-13
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