European Commission - Growth

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Notification
Found : 30
 
  Body :

RISE Research Institutes of Sweden AB
Box 857
501 15 BORAS
Country : Sweden

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

Email : info@ri.se
Website : www.ri.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 42 43 44 45 46 47 48

Last approval date : 04/03/2020
 

Return to legislation list

Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last approval date : 02/10/2019                 Version(s): 1 2 3 4 5

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 0102 - Non-active devices for injection, infusion, transfusion and dialysis
 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 0103 - Non-active orthopaedic and rehabilitation 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 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
 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 0200 - Non-active implants
  
   - *MD 0202 - Non-active orthopaedic implants
 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 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 0300 - Devices for wound care
  
   - *MD 0301 - Bandages and wound dressings
 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 0303 - Other medical devices for wound care
 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 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
 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 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 1103 - Devices for stimulation or inhibition
 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 1104 - Active surgical 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 1106 - Active dental devices
 Full quality assurance system
Production quality assurance
Product quality assurance		 Annex II
Annex V
Annex VI		  
   - *MD 1107 - Active devices for disinfection and sterilisation
 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 1108 - Active rehabilitation devices and active prostheses
 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 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 1202 - Imaging devices utilising non-ionizing radiation
 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 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		  
 
Horizontal technical competence Limitations
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
*MDS 7010 - Medical devices incorporating software /utilising software /controlled by software