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Found : 30
  Body :

TUV NORD Polska Sp. z o.o
ul. Mickiewicza 29
40-085 Katowice
Country : Poland

Phone : +48 32 7864646
Fax : +48 32 7864601

Email : biuro@tuv-nord.pl
Website : www.tuv-nord.pl

Notified Body number : 2274

Version(s): 1 2

Last update : 22/10/2012
 

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Some information about the accreditation details are available in the PDF
Legislation
93/42/EEC Medical devices    
Last update : 17/02/2014                 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
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 0107 - Contraceptive medical devices
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 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 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
   - *MD 1102 - Respiratory devices, devices including hyperbaric chambers for oxygen therapy, inhalation anaesthesia
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 1103 - Devices for stimulation or inhibition
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *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
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
without acitive prostheses 
   - *MD 1109 - Active devices for patient positioning and transport
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
Annex II
Annex V
 
*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
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
 
*MD 1400 - Devices for radiation therapy and thermo therapy
 
   - *MD 1401 - Devices utilising ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
   - *MD 1402 - Devices utilising non-ionizing radiation
Full quality assurance system
Production quality assurance
Product quality assurance
Annex II
Annex V
Annex VI
 
 
Horizontal technical competence Limitations
*MDS 7001 - Medical devices incorporating medicinal substances, according to Directive 2001/83/EC  
*MDS 7004 - Medical devices referencing the Directive 2006/42/EC on machinery  
*MDS 7006 - Medical devices in sterile condition  
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