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Notification

Found : 23
  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     (History)
Last update : 09/10/2012                 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 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
only infusion pumps 
   - *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 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 7005 - Medical devices referencing the Directive 89/686/EEC on personal protective equipment (PPE)  
*MDS 7006 - Medical devices in sterile condition  
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