Navigation path


Notification

Found : 18
  Body (History):

SP Sveriges Tekniska Forskningsinstitut AB
Box 857
501 15 BORAS
Country : Sweden

Phone : +46 (0) 10 516 50 00
Fax : +46 (0) 33 13 55 02

Email : info@sp.se
Website : www.sp.se

Notified Body number : 0402

Version(s): 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34 35 36 37 38 39 40 41

Last update : 17/01/2011
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 11/03/2010                 Version(s): 1 2

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
 
   - *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 0200 - Non-active implants
 
   - *MD 0203 - Non-active functional implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
Bone-anchored implants for dental and cranio-facial reconstruction 
*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 0403 - Dental implants
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
Bone-anchored implants for dental and cranio-facial reconstruction 
*MD 1100 - General active medical devices
 
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1106 - Active dental devices
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1111 - Software
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
*MD 1200 - Devices for imaging
 
   - *MD 1201 - Imaging devices utilising 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
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1302 - Monitoring devices of vital physiological parameters
Full quality assurance system
Production quality assurance
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 7005 - Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE)  
*MDS 7006 - Medical devices in sterile condition  
Set page to normal font size Increase font size by 200 percentprint this page