European Commission - Growth

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Notification

Found : 29
 
  Body :

Schweizerische Vereinigung für Qualitäts- und Managementsysteme
Bernstrasse 103
3052 Zollikofen
Country : Switzerland

Phone : +41 (0)58 710 35 35
Fax : +41 (0)58 710 35 45

Email : headoffice@sqs.ch
Website : www.sqs.ch

Notified Body number : 1250

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

Last approval date : 29/01/2021
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 11/02/2018                 Version(s): 1 2 3 4 5 6 7

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0104 - Non-active medical devices with measuring function
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0106 - Non-active instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0200 - Non-active implants
 
   - *MD 0202 - Non-active orthopaedic implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0303 - Other medical devices for wound care
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0402 - Dental materials
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 0403 - Dental implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*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
excluding heart-lung machine 
   - *MD 1103 - Devices for stimulation or inhibition
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
excluding life sustaining devices  
   - *MD 1104 - Active surgical devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1106 - Active dental devices
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1111 - Software
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1112 - Medical gas supply systems and parts thereof
EC declaration of conformity (full quality assurance system) Annex II  
*MD 1200 - Devices for imaging
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
without devices specifically intended for monitoring of vital physiological parameters where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of CNS 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
EC declaration of conformity (full quality assurance system)
EC declaration of conformity (production quality assurance)
EC declaration of conformity (product quality assurance)
Annex II
Annex V
Annex VI
 
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition Including ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam), plasma sterilization
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed  
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software