Navigation path


Notification

Found : 4
  Body :

TÜV SÜD Product Service GmbH Zertifizierstellen
Ridlerstraße 65
80339 MÜNCHEN
Country : Germany

Phone : +49 (89) 50084261
Fax : +49 (89) 50084230

Email : ps.zert@tuev-sued.de
Website : http://www.tuev-sued.de/ps

Notified Body number : 0123

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19

Last update : 29/05/2012
 

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 : 23/09/2010                 Version(s): 1 2 3 4 5 6

Products Procedures Articles/Annexes Limitations
*AIMD 0100 - General active implantable medical devices
 
   - *AIMD 0101 - Active implantable medical devices for stimulation / inhibition
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
 
   - *AIMD 0102 - Active implantable medical devices delivering drugs or other substances
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
 
   - *AIMD 0103 - Active implantable medical devices substituting or replacing organ functions
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
 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
Set page to normal font size Increase font size by 200 percentprint this page