Basic Information Booklet We have issued a booklet which
is intended to provide an introduction to the principles of European New Approach
Directives and in particular the Medical Devices Directive 93/42/EEC (MDD): Its purpose is
to help medical device manufacturers to understand and comply with the MDD and CE marking
requirements. Numerous seminars, discussions with clients and mdc's auditors and experts,
and phone calls were the basis for constructing this booklet.
The booklet is divided into
individual chapters - each designed to be self-contained - and includes a list of selected
literature and an index at the end.
Such a brief introduction
can never replace the detailed study of legal text and necessarily conta ins some
omissions and simplifications. Moreover attention is drawn to the ongoing discussions of
various working groups established by the European Commission to develop guidelines on the
application of the MDD. The consensus of these working groups is published as MEDDEV
documents which are revised from time to time.
For this reason the authors
and editor of this booklet refuse any liability for the accuracy of the information
provided.
MDD mdc basic info booklet (PDF, 237 KB)
If you wish to receive a
printed version of the brochure for free, please contact us at the address at the end of
this page.
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