Basic Information about the European Directive 93/42/EEC on ...

PREFACE
<strong>Basic</strong> <strong>Information</strong> MDD <strong>93</strong>/<strong>42</strong>/<strong>EEC</strong>
This booklet is intended to provide an introduction to <strong>the</strong> principles of <strong>European</strong> ‘New Approach
<strong>Directive</strong>s’ and in particular of <strong>the</strong> Medical Device <strong>Directive</strong> <strong>93</strong>/<strong>42</strong>/<strong>EEC</strong> (MDD). Its purpose is to help
medical device manufacturers to understand and comply with <strong>the</strong> MDD and CE-marking requirements.
Numerous discussions with clients, auditors and experts were <strong>the</strong> basis for constructing this booklet.
The booklet is divided into individual chapters - each designed to be self-contained - and includes
references to fur<strong>the</strong>r supporting documents.
Such a brief introduction can never replace <strong>the</strong> detailed study of legal text. Here we would like to draw
your attention to <strong>the</strong> MEDDEV documents and Notified Bodies Medical Device (NB-MED)
Recommendations which contain <strong>the</strong> results of various working groups established by <strong>the</strong> <strong>European</strong>
Commission.
Although mdc is always close to <strong>the</strong>se working groups we cannot guarantee for <strong>the</strong> accuracy of <strong>the</strong>
information provided.
Stuttgart, Germany, October 2009
© mdc medial device certification GmbH
040100/6 Page 2 of 20 © mdc / 2009-11-13