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Bodies
Found : 8
Search criteria :
Legislation :
Regulation (EU) 2017/746 on in vitro diagnostic medical devices
Procedure /
Article or annex :
ALL
Conformity assessment based on a quality management system / Annex IX(I)
Conformity assessment based on assessment of technical documentation / Annex IX(II)
Conformity assessment based on product quality assurance / Annex XI
Conformity assessment based on type-examination / Annex X
Products :
ALL
I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE
1. Devices intended to be used for blood grouping
IVR 0101 Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]
IVR 0102 Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]
IVR 0103 Devices intended to determine markers of the Kell system [Kel1 (K)]
IVR 0104 Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]
IVR 0105 Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]
IVR 0106 Other devices intended to be used for blood grouping
2. Devices intended to be used for tissue typing
IVR 0201 Devices intended to be used for tissue typing (HLA A, B, DR) to ensure the immunological compatibility of bl...
IVR 0202 Other devices intended to be used for tissue typing
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
IVR 0302 Other devices intended to be used for markers of cancer and non-malignant tumours
4. Devices intended to be used for human genetic testing
IVR 0401 Devices intended to be used in screening/confirmation of congenital/inherited disorders
IVR 0402 Devices intended to be used to predict genetic disease/disorder risk and prognosis
IVR 0403 Other devices intended to be used for human genetic testing
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 towar...
IVR 0502 Devices intended to be used to detect the presence of, or exposure to transmissible agents in blood, blood c...
IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually...
IVR 0504 Devices intended to be used to determine the infectious load, to determine infective disease status or immun...
IVR 0505 Devices intended to be used to grow/isolate/identify and handle infectious agents
IVR 0506 Other devices intended to be used to determine markers of infections/immune status
6. Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except...
IVR 0601 Devices intended to be used for screening/confirmation of specific disorders/impairments
IVR 0602 Devices intended to be used for screening, determination or monitoring of physiological markers for a specif...
IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intole...
IVR 0604 Other devices intended to be used for a specific disease
IVR 0605 Devices intended to be used for monitoring of levels of medicinal products, substances or biological components
IVR 0606 Devices intended to be used for non-infectious disease staging
IVR 0607 Devices intended to be used for detection of pregnancy or fertility testing
IVR 0608 Devices intended to be used for screening, determination or monitoring of physiological markers
IVR 0609 Other devices intended to be used to define or monitor physiological status and therapeutic measures
7. Devices which are controls without a quantitative or qualitative assigned value
IVR 0701 Devices which are controls without a quantitative assigned value
IVR 0702 Devices which are controls without a qualitative assigned value
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
IVR 0802 Instruments intended specifically to be used for in vitro diagnostic procedures referred to in point 2.5 (ru...
IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746
1. In vitro diagnostic devices with specific characteristics
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 1004 Devices manufactured utilising tissues or cells of human origin, or their derivatives
IVS 1005 Devices in sterile condition
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 mult...
IVS 1008 Instruments, equipment, systems or apparatus
IVS 1009 Software that are devices in themselves including software apps, software for data analysis, and for definin...
IVS 1010 Devices incorporating software/utilising software/controlled by software
2. In vitro diagnostic devices for which specific technologies are used
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, leat...
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
3. In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of produc...
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...
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
4. In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purp...
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 org...
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...
IVD 4006 In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics
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
Horizontal technical competence :
ALL
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 1004 Devices manufactured utilising tissues or cells of human origin, or their derivatives
IVS 1005 Devices in sterile condition
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 mult...
IVS 1008 Instruments, equipment, systems or apparatus
IVS 1009 Software that are devices in themselves including software apps, software for data analysis, and for definin...
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, leat...
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...
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 org...
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...
IVD 4006 In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics
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
Withdrawn/Expired/Suspended Notifications/NBs are not displayed in this list, you can find them in the Body module under the hyperlink
"Withdrawn/Expired/Suspended Notifications/NBs"
Body type
Name
Country
NB 2265
3EC International a.s.
Slovakia
NB 2797
BSI Group The Netherlands B.V.
Netherlands
NB 0344
DEKRA Certification B.V.
Netherlands
NB 0124
DEKRA Certification GmbH
Germany
NB 0459
GMED SAS
France
NB 2962
QMD Services GmbH
Austria
NB 0197
TÜV Rheinland LGA Products GmbH
Germany
NB 0123
TÜV SÜD Product Service GmbH
Germany
European Commission - Growth