ANNEX IISupplementary provisions
ANNEX II The list of codes and corresponding types of devices for the purpose of specifying the scope of the designation as notified bodies in the field of in vitro diagnostic medical devices under Regulation (EU) 2017/746 I. CODES REFLECTING THE DESIGN AND INTENDED PURPOSE OF THE DEVICE 1. Devices intended to be used for blood grouping IVR CODE Devices intended to be used to determine markers of the specific blood grouping systems to ensure the immunological compatibility of blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration 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)] Other devices intended to be used for blood grouping IVR 0106 Other devices intended to be used for blood grouping 2. Devices intended to be used for tissue typing IVR CODE 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 blood, blood components, cells, tissue or organs that are intended for transfusion or transplantation or cell administration 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 CODE Devices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testing 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 CODE 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 CODE Devices intended to be used for the screening, confirmation, identification of infectious agents or determination of 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 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 IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents 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 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 human genetic testing), and therapeutic measures IVR CODE Devices intended to be used for a specific disease 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 specific disease IVR 0603 Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances IVR 0604 Other devices intended to be used for a specific disease Devices intended to be used to define or monitor physiological status and therapeutic measures 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 CODE 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 CODE 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 (rule 5), under b), of Annex VIII to Regulation (EU) 2017/746 IVR 0803 Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 II. HORIZONTAL CODES 1. In vitro diagnostic devices with specific characteristics IVS CODE 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 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 2. In vitro diagnostic devices for which specific technologies are used IVT CODE 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, 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 3. In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verification IVP CODE In vitro diagnostic devices which require specific knowledge in examination procedures 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 4. In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification IVD CODE In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verification 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 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