IVDD Basic Information Booklet
We have issued a booklet which 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 contains some omissions and simplifications. Moreover attention is drawn to
the ongoing discussions of various working groups established by the European Commissi on
to develop guidelines on the application of the European Directive on in vitro Diagnostic
Devices. The consensus of these working groups is published as MEDDEV documents and
Notified Bodies Medical Device (NB-MED) Recommendations which are revised from time to
time.
For this reason mdc refuses
any liability for the accuracy of the information provided.
IVDD mdc basic info booklet in pdf format (PDF, 264 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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