Document Detail

Germany's competent authority initiatives.
MedLine Citation:
PMID:  10164095     Owner:  NLM     Status:  MEDLINE    
A decentralised approach on the enforcement's' responsibility of the medical devices act, which includes the directives and the guidelines for the vigilance system, has been adopted in Germany. DIMDI under this act, had been nominated to set up a database-supported information system, that would ensure secure usage of medical devices in Germany. The necessary measures taken in order to fulfil the German legislation as well as DIMDI's points of view for the international data exchange on medical devices are being discussed in this paper.
W Stober
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Studies in health technology and informatics     Volume:  28     ISSN:  0926-9630     ISO Abbreviation:  Stud Health Technol Inform     Publication Date:  1996  
Date Detail:
Created Date:  1997-02-11     Completed Date:  1997-02-11     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  9214582     Medline TA:  Stud Health Technol Inform     Country:  NETHERLANDS    
Other Details:
Languages:  eng     Pagination:  96-100     Citation Subset:  T    
German Institute for Medical Documentation and Information (DIMDI) Köln, Germany.
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MeSH Terms
Equipment and Supplies* / standards
Guidelines as Topic
Information Systems
Legislation, Medical
Product Surveillance, Postmarketing* / methods,  standards

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