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Notification

Found : 46
  Body (History):

DET NORSKE VERITAS CERTIFICATION AS
Veritasveien 1
1322 HOVIK
Country : Norway

Phone : +47/67.57.99.00
Fax : +47/67.57.74.74

Email : distribution@dnv.com
Website : www.dnv.com

Notified Body number : 0434

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

Last update : 21/11/2011
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 04/01/2013                 Version(s): 1 2 3

Products Procedures Articles/Annexes Limitations
*MD 0100 - General non-active, non-implantable medical devices
 
   - *MD 0101 - Non-active devices for anaesthesia, emergency and intensive care
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0102 - Non-active devices for injection, infusion, transfusion and dialysis
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0103 - Non-active orthopaedic and rehabilitation devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0104 - Non-active medical devices with measuring function
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0105 - Non-active ophthalmologic devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0106 - Non-active instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0107 - Contraceptive medical devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0108 - Non-active medical devices for disinfecting, cleaning, rinsing
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0109 - Non-active devices for in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0200 - Non-active implants
 
   - *MD 0201 - Non-active cardiovascular implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0202 - Non-active orthopaedic implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0203 - Non-active functional implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0204 - Non-active soft tissue implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0302 - Suture material and clamps
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0303 - Other medical devices for wound care
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 0400 - Non-active dental devices and accessories
 
   - *MD 0401 - Non-active dental equipment and instruments
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0402 - Dental materials
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 0403 - Dental implants
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1100 - General active medical devices
 
   - *MD 1101 - Devices for extra-corporal circulation, infusion and haemopheresis
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1103 - Devices for stimulation or inhibition
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1104 - Active surgical devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1105 - Active ophthalmologic devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1106 - Active dental devices
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1107 - Active devices for disinfection and sterilisation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1108 - Active rehabilitation devices and active prostheses
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1109 - Active devices for patient positioning and transport
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1110 - Active devices for in vitro fertilisation (IVF) and assisted reproductive therapy (ART)
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1111 - Software
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1202 - Imaging devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1300 - Monitoring devices
 
   - *MD 1301 - Monitoring devices of non-vital physiological parameters
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1403 - Devices for hyperthermia / hypothermia
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
   - *MD 1404 - Devices for (extracorporal) shock-wave therapy (lithotripsy)
Full quality assurance system
Production quality assurance
Annex II
Annex V
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC  
*MDS 7002 - Medical devices utilising tissues of animal origin, including Regulation 722/2012 (Directive 2003/32/EC up to 28.08.2013)  
*MDS 7003 - Medical devices incorporating derivates of human blood, according to Directive 2000/70/EC, amended by Directive 2001/104/EC  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery DNV is also a NB for that directive
*MDS 7006 - Medical devices in sterile condition  
*MDS 7007 - Medical devices utilising micromechanics  
*MDS 7009 - Medical devices utilising biological active coatings and/or materials or being wholly or mainly absorbed  
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