European Commission - Enterprise and Industry

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Notification

Found : 1
 
  Body :

BSI Group Deutschland GmbH
Hanauer Landstrasse 115
60314 Frankfurt am Main
Country : Germany

Phone : +49 (69) 22 22 89 200
Fax : +49 (69) 22 22 89 300

Email : md-cert.de@bsigroup.com
Website : www.bsigroup.de

Notified Body number : 0535

Version(s): 1 2 3 4 5 6 7 8 9 10

Last update : 09/10/2012
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
90/385/EEC Active implantable medical devices     (History)
Last update : 10/07/2008                 Version(s): 1 2

Products Procedures Articles/Annexes Limitations
All active implantable medical devices
EC declaration of conformity (complete quality assurance system)
EC declaration of conformity to type (assurance of production quality)
EC type-examination
EC verification
Annex 2
Annex 5
Annex 3
Annex 4