European Commission - Growth

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Notification

Found : 5
 
  Body :

Eurofins Product Service GmbH
Storkower Stra├če 38c
15526 REICHENWALDE
Country : Germany

Phone : +49 (0) 33 631 888 0
Fax : +49 (0) 33 631 888 660

Email : certifiers@eurofins.com
Website : www.eurofins.de

Notified Body number : 0681

 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 08/06/2017
Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
excluding class III devices (valid for the complete scope)  
*MD 1100 - General active medical devices
 
   - *MD 1108 - Active rehabilitation devices and active prostheses
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
excluding class III devices (valid for the complete scope)  
   - *MD 1109 - Active devices for patient positioning and transport
EC type-examination
EC verification
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex III
Annex IV
Annex II
Annex V
Annex VI
excluding class III devices (valid for the complete scope)  
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software