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Notification

Found : 23
  Body :

SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Trzaska cesta 2
1000 LJUBLJANA
Country : Slovenia

Phone : +386:1:4778 100
Fax : +386:1:4778 444

Email : info@siq.si
Website : http://www.siq.si/

Notified Body number : 1304

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

Last update : 06/01/2010
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices     (History)
Last update : 28/07/2010                 Version(s): 1 2 3 4 5 6

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
Product quality assurance
Annex II
Annex V
Annex VI
only tracheal tubes, urinary catheters, tubing for anaesthesia included 
   - *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
only catheters and tubing included 
   - *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 0105 - Non-active ophthalmologic devices
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 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
hip joints excluded 
*MD 0300 - Devices for wound care
 
   - *MD 0301 - Bandages and wound dressings
Production quality assurance Annex V  
   - *MD 0302 - Suture material and clamps
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
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
only infant incubators included 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
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
hyperbaric chambers for oxygen therapy and inhalation anaesthesia excluded 
   - *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
EC type-examination
EC verification
Production quality assurance
Product quality assurance
Annex II
Annex III
Annex IV
Annex V
Annex VI
only lasers for medical use included 
   - *MD 1105 - Active ophthalmologic devices
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
only lasers for medical use included 
   - *MD 1106 - Active dental devices
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
only lasers for medical use included 
   - *MD 1107 - Active devices for disinfection and sterilisation
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 1111 - Software
Full quality assurance system
Production quality assurance
Annex II
Annex V
class III devices excluded 
*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  
*MDS 7006 - Medical devices in sterile condition  
Procedures sub-contracted to other bodies:    
  • EC type-examination    
  • EC verification
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