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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CONTENTS<br />
CE-MARKING: THE PRINCIPLES OF EUROPEAN DIRECTIVES .........................................................................4<br />
NOTIFIED BODIES....................................................................................................................................................5<br />
MDD: THE MEDICAL DEVICES DIRECTIVE <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> INCLUDING DIRECTIVE 2007/47/EC...........................6<br />
MEDICAL DEVICE CLASSIFICATION .....................................................................................................................8<br />
QUALITY SYSTEMS: ISO 9001 - ISO 13485 – CE-MARK ......................................................................................9<br />
TECHNICAL FILES - RISK ANALYSIS - HARMONIZED STANDARDS ..............................................................10<br />
THE EUROPEAN MEDICAL DEVICE VIGILANCE SYSTEM ................................................................................11<br />
HOW TO OBTAIN THE CE-MARK – STEPS IN THE CERTIFICATION PROCEDURE .......................................12<br />
mdc – NOTIFIED BODY 0483.................................................................................................................................18<br />
FURTHER INFORMATION AND DOCUMENTS ....................................................................................................19<br />
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