European Commission - Enterprise and Industry

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Notification

Found : 9
 
  Body (History):

Bureau Veritas Consumer Product Service Germany GmbH
Wilhelm-Hennemann-Stra├če 8
19061 Schwerin
Country : Germany

Phone : +49 (8245) 968100
Fax : +49 (8245) 9681099

Email : achim.haenchen@de.bureauveritas.com
Website : http://www.bureauveritas.com

Notified Body number : 2004

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

Last update : 11/01/2011
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 22/04/2010                 Version(s): 1 2 3 4 5

Products Procedures Articles/Annexes Limitations
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
Except hyperbaric chambers 
   - *MD 1103 - Devices for stimulation or inhibition
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1104 - Active surgical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1111 - Software
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
Full quality assurance system
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery