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Notification
Found : 32
 
  Body :

3EC International a.s.
3EC International a.s. Hranicna 18 Bratislava 82105 SLOVAKIA
Bratislava 82105
Country : Slovakia

Phone : +421 2 58318343
Fax : +421 2 58318345

Email : info@3ec.sk
Website : www.3ec.sk

Notified Body number : 2265

Version(s): 1 2 3

Last approval date : 20/01/2019
 

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Some information about the accreditation details are available in the PDF
Legislation
Regulation (EU) 2017/746 on in vitro diagnostic medical devices    
Last approval date : 30/04/2022
Products Procedures Annexes Conditions
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
  
   - 3. Devices intended to be used for markers of cancer and non-malignant tumours
  
   -
      - IVR 0301 Devices intended to be used in screening, diagnosis, staging or monitoring of cancer
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   - 4. Devices intended to be used for human genetic testing
  
   -
      - IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0403 Other devices intended to be used for human genetic testing
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   - 5. Devices intended to be used to determine markers of infections/immune status
  
   -
      - IVR 0501 Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood components, cells, tissues or organs, or in any of their derivatives, to assess their suitability for transfusion, transplantation or cell administration
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0506 Other devices intended to be used to determine markers of infections/immune status
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   - 6. Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures
  
   -
      - IVR 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0604 Other devices intended to be used for a specific disease
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0606 Devices intended to be used for non-infectious disease staging
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   - 7. Devices which are controls without a quantitative or qualitative assigned value
  
   -
      - IVR 0701 Devices which are controls without a quantitative assigned value
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0702 Devices which are controls without a qualitative assigned value
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   - 8. Class A devices in sterile condition
  
   -
      - IVR 0801 Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
   -
      - IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
 Conformity assessment based on a quality management system
Conformity assessment based on assessment of technical documentation
Conformity assessment based on product quality assurance		 Annex IX(I)
Annex IX(II)
Annex XI		  
 
Horizontal technical competence Limitations
IVS 1001 Devices intended to be used for near-patient testing  
IVS 1002 Devices intended to be used for self-testing  
IVS 1003 Devices intended to be used as companion diagnostics  
IVS 1005 Devices in sterile condition aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)
IVS 1006 Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)  
IVS 1007 Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (point 1.6 of Annex VIII to Regulation (EU) 2017/746)  
IVS 1008 Instruments, equipment, systems or apparatus  
IVS 1009 Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures  
IVS 1010 Devices incorporating software/utilising software/controlled by software  
IVT 2001 In vitro diagnostic devices manufactured using metal processing  
IVT 2002 In vitro diagnostic devices manufactured using plastic processing  
IVT 2003 In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)  
IVT 2004 In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)  
IVT 2005 In vitro diagnostic devices manufactured using biotechnology  
IVT 2006 In vitro diagnostic devices manufactured using chemical processing  
IVT 2007 In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals  
IVT 2008 In vitro diagnostic devices manufactured in clean rooms and associated controlled environments  
IVT 2009 In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin  
IVT 2010 In vitro diagnostic devices manufactured using electronic components including communication devices  
IVT 2011 In vitro diagnostic devices which require packaging, including labelling  
IVP 3001 In vitro diagnostic devices which require knowledge regarding agglutination tests  
IVP 3002 In vitro diagnostic devices which require knowledge regarding biochemistry  
IVP 3003 In vitro diagnostic devices which require knowledge regarding chromatography  
IVP 3004 In vitro diagnostic devices which require knowledge regarding chromosomal analysis  
IVP 3005 In vitro diagnostic devices which require knowledge regarding coagulometry  
IVP 3006 In vitro diagnostic devices which require knowledge regarding flow cytometry  
IVP 3007 In vitro diagnostic devices which require knowledge regarding immunoassays  
IVP 3008 In vitro diagnostic devices which require knowledge regarding lysis based testing  
IVP 3009 In vitro diagnostic devices which require knowledge regarding measurement of radioactivity  
IVP 3010 In vitro diagnostic devices which require knowledge regarding microscopy  
IVP 3011 In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)  
IVP 3012 In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry  
IVP 3013 In vitro diagnostic devices which require knowledge regarding spectroscopy  
IVP 3014 In vitro diagnostic devices which require knowledge regarding tests of cell function  
IVD 4001 In vitro diagnostic devices which require knowledge regarding bacteriology  
IVD 4002 In vitro diagnostic devices which require knowledge regarding clinical chemistry/biochemistry  
IVD 4003 In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)  
IVD 4004 In vitro diagnostic devices which require knowledge regarding genetics  
IVD 4005 In vitro diagnostic devices which require knowledge regarding haematology/haemostasis, including coagulation disorders  
IVD 4007 In vitro diagnostic devices which require knowledge regarding immunohistochemistry/histology  
IVD 4008 In vitro diagnostic devices which require knowledge regarding immunology  
IVD 4009 In vitro diagnostic devices which require knowledge regarding molecular biology/diagnostics  
IVD 4010 In vitro diagnostic devices which require knowledge regarding mycology  
IVD 4011 In vitro diagnostic devices which require knowledge regarding parasitology  
IVD 4012 In vitro diagnostic devices which require knowledge regarding virology