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Downloads
1. Legislation
- AIMDD
[640 KB]
- MDD
[241 KB]
- IVDD
[210 KB]
- EMC
[719 KB]
- LVD
[389 KB]
- WEEE
[98 KB]
- RoHS
[115 KB]
2. Supportive Information
- List
of Competent Authorities
- List
of Harmonized Standards for MDD
-
List of Harmonized Standards for
IVDD
- List
of Notified Bodies
- List
of MEDDEV docs for MDD and IVDD
Links
European Links:
European
Union Homepage
European
Union New Approach to Standards and Directives
GHTF
- Homepage [ Global Harmonization Task Force ]
EUROPEAN
UNION in the US [ The official Website of the European
Union in the US ]
EUCOMED
[ European Confederation of Medical Devices Associations ]
www.edma-ivd.be
[ European Diagnostic Manufacturers Association ]
www.iso.ch
[ International Organization for Standardization ]
www.beuth.de
[ Publisher of European Standards ]
Notified
Bodies: List of Notified Bodies for Medical Devices
US and Canadian Links:
FDA
[ Food and Drug Administration - U.S. Department of Health
and Human Services ]
Medical
Devices Bulletin [ FDA Center for Devices and Radiological
Health ]
Canada
Health Product & Food
www.raps.org
[ Regulatory Affairs Professionals Society – RAPS Homepage
]
General Information
www.devicelink.com
[ medical device links to companies world-wide ]
Health
Finder [ many Links, with search function ]
Health
Gate [ information and news ]
Medical
Matrix [ listings, searching, links ]
Health
Monitoring System [ of Germany (Federal) ]
Onmeda
[ Information and German links with a search
engine (German Language) ]
MediConf
[ Database on Medical Conferences and Exhibitions Worldwide;
lists over 9000 coming events including conferences, workshops,
seminars, symposia and exhibitions in the fields of medicine,
healthcare, pharmacology, and biotechnology ]
News
CLINICA [ Worldwide diagnostic
and medical device news ]
British
Medical Journal [ Good archive/search functions ]
CNN
Health [ News and stories ]
REUTERS
Health News [ Daily news ]
Yahoo
medicine [ Categories, search service, listing ]
Glossary
Glossary
of medical terms [ Multilingual Glossary of technical
and popular medical terms in nine European Languages ]
Publications & Articles
Complying
with EU language requirements [ By Aidan Collins, Celer
Pawlowsky ]
The
Contractual Obligations of Outsourcing Companies and Vendors
[By mdi Europa]
The
general process of medical device CE marking [By mdi
Europa]
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