Notification of a Body in the framework of technical ...



Applied-for scope of designation and notification of a Conformity Assessment Body – Regulation (EU) 2017/746 (IVDR)Name of the national authority responsible for notified bodies (DA) FORMTEXT ?????Name of the applicant conformity assessment body (CAB) and, if applicable, notified body's identification number FORMTEXT ????? FORMTEXT ?????Address of the CAB FORMTEXT ?????Date of application (not before 26 Nov 2017) FORMTEXT ?????I Codes reflecting the design and intended purpose of the device Please mark the selected types of products and conformity assessment activities with a cross (X) in the grey coloured columns below. The different lists of codes are in accordance with the Implementing Regulation on the list of codes. Conformity assessment activities are identified by the corresponding reference to the Annex of the MDR. The products and activities selected below will constitute the applied-for scope of application and therefore should be linked to the conformity assessment body's competence. Conditions, such as limitations must be included when applicable (e.g. when the competence cannot be justified for the whole code). 1. Devices intended to be used for blood groupingIVR CODEDevices 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 administrationAnnexesConditionsIX(I)IX(II)XXIIVR 0101Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]???? FORMTEXT ?????IVR 0102Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]???? FORMTEXT ?????IVR 0103Devices intended to determine markers of the Kell system [Kel1 (K)]???? FORMTEXT ?????IVR 0104Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]???? FORMTEXT ?????IVR 0105Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]???? FORMTEXT ?????IVR CODEOther devices intended to be used for blood groupingIVR 0106Other devices intended to be used for blood grouping???? FORMTEXT ?????2. Devices intended to be used for tissue typingIVR CODEDevices intended to be used for tissue typingAnnexesConditionsIX(I)IX(II)XXIIVR 0201Devices 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???? FORMTEXT ?????IVR 0202Other devices intended to be used for tissue typing???? FORMTEXT ?????3. Devices intended to be used for markers of cancer and non-malignant tumoursIVR CODEDevices intended to be used for markers of cancer and non-malignant tumours except devices for human genetic testingAnnexesConditionsIX(I)IX(II)XXIIVR 0301Devices intended to be used in screening, diagnosis, staging or monitoring of cancer???? FORMTEXT ?????IVR 0302Other devices intended to be used for markers of cancer and non-malignant tumours???? FORMTEXT ?????4. Devices intended to be used for for human genetic testingIVR CODEDevices intended to be used for human genetic testingAnnexesConditionsIX(I)IX(II)XXIIVR 0401Devices intended to be used in screening / confirmation of congenital / inherited disorders???? FORMTEXT ?????IVR 0402Devices intended to be used to predict genetic disease/disorder risk and prognosis???? FORMTEXT ?????IVR 0403Other devices intended to be used for human genetic testing???? FORMTEXT ?????5. Devices intended to be used to determine markers of infections / immune statusIVR CODEDevices intended to be used for the screening, confirmation, identification of infectious agents or determination of immune statusAnnexesConditionsIX(I)IX(II)XXIIVR 0501Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents???? FORMTEXT ?????IVR 0502Devices 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???? FORMTEXT ?????IVR 0503Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents???? FORMTEXT ?????IVR 0504Devices intended to be used to determine the infectious load, to determine infective disease status or immune status and devices used for infectious disease staging???? FORMTEXT ?????IVR 0505Devices intended to be used to grow / isolate / identify and handle infectious agents???? FORMTEXT ?????IVR 0506Other devices intended to be used to determine markers of infections / immune status???? FORMTEXT ?????6. Devices intended to be used for non-infectious pathologies, physiological markers, disorders / impairments (except human genetic testing), and therapeutic measuresIVR CODEDevices intended to be used for a specific diseaseAnnexesConditionsIX(I)IX(II)XXIIVR 0601Devices intended to be used for screening / confirmation of specific disorders / impairments ???? FORMTEXT ?????IVR 0602Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease ???? FORMTEXT ?????IVR 0603Devices intended to be used for screening, confirmation / determination, or monitoring of allergies and intolerances???? FORMTEXT ?????IVR 0604Other devices intended to be used for a specific disease???? FORMTEXT ?????IVR CODEDevices intended to be used to define or monitor physiological status and therapeutic measuresIVR 0605Devices intended to be used for monitoring of levels of medicinal products, substances or biological components???? FORMTEXT ?????IVR 0606Devices intended to be used for non-infectious disease staging???? FORMTEXT ?????IVR 0607Devices intended to be used for detection of pregnancy or fertility testing???? FORMTEXT ?????IVR 0608Devices intended to be used for screening, determination or monitoring of physiological markers???? FORMTEXT ?????IVR 0609Other devices intended to be used to define or monitor physiological status and therapeutic measures???? FORMTEXT ?????7. Devices which are controls without a quantitative or qualitative assigned valueIVR CODEControls without a quantitative or qualitative assigned valueAnnexesConditionsIX(I)IX(II)XXIIVR 0701Devices which are controls without a quantitative assigned value???? FORMTEXT ?????IVR 0702Devices which are controls without a qualitative assigned value???? FORMTEXT ?????8. Class A devices in sterile conditionIVR CODEClass A devices in sterile conditionAnnexesConditionsIX(I)IX(II)XXIIVR 0801Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746 ???? FORMTEXT ?????IVR 0802Instruments 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 ???? FORMTEXT ?????IVR 0803Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 ???? FORMTEXT ?????II HORIZONTAL CODES Please mark the selected horizontal areas and technologies in the grey coloured columns below. The different lists of codes are in accordance with the Implementing Regulation on the list of codes. The areas and technologies selected will be part of the applied-for scope of application and therefore each of these areas should be linked to the conformity assessment body's competence. Conditions, such as limitations must be included when applicable (e.g. when the competence cannot be justified for the whole code). 1. In vitro diagnostic devices with specific characteristicsIVS CODEIn vitro diagnostic devices with specific characteristicsSelectConditionsIVS 1001Devices intended to be used for near-patient testing? FORMTEXT ?????IVS 1002Devices intended to be used for self-testing ? FORMTEXT ?????IVS 1003Devices intended to be used as companion diagnostics? FORMTEXT ?????IVS 1004Devices manufactured utilising tissues or cells of human origin, or their derivatives? FORMTEXT ?????IVS 1005Devices in sterile condition?Please indicate which of the following processes are coveredIncluding aseptic processing, ethylene oxide gas sterilisation (EOG), low temperature steam and formaldehyde sterilisation, moist heat sterilisation, radiation sterilisation (gamma, x-ray, electron beam)If designation is sought for other processes, these need to be specifiedIVS 1006Calibrators (point 1.5 of Annex VIII to Regulation (EU) 2017/746)? FORMTEXT ?????IVS 1007Control 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)? FORMTEXT ?????IVS 1008Instruments, equipment, systems or apparatus ? FORMTEXT ?????IVS 1009Software that are devices in themselves including software apps, software for data analysis, and for defining or monitoring therapeutic measures? FORMTEXT ?????IVS 1010Devices incorporating software / utilising software / controlled by software? FORMTEXT ?????2. In vitro diagnostic devices for which specific technologies are usedIVT CODEIn vitro diagnostic devices for which specific technologies are usedSelectConditionsIVT 2001In vitro diagnostic devices manufactured using metal processing? FORMTEXT ?????IVT 2002In vitro diagnostic devices manufactured using plastic processing? FORMTEXT ?????IVT 2003In vitro diagnostic devices manufactured using non-metal mineral processing (e.g. glass, ceramics)? FORMTEXT ?????IVT 2004In vitro diagnostic devices manufactured using non-metal non-mineral processing (e.g. textiles, rubber, leather, paper)? FORMTEXT ?????IVT 2005In vitro diagnostic devices manufactured using biotechnology? FORMTEXT ?????IVT 2006In vitro diagnostic devices manufactured using chemical processing ? FORMTEXT ?????IVT 2007In vitro diagnostic devices which require knowledge regarding the production of pharmaceuticals? FORMTEXT ?????IVT 2008In vitro diagnostic devices manufactured in clean rooms and associated controlled environments? FORMTEXT ?????IVT 2009In vitro diagnostic devices manufactured using processing of materials of human, animal or microbial origin? FORMTEXT ?????IVT 2010In vitro diagnostic devices manufactured using electronic components including communication devices? FORMTEXT ?????IVT 2011In vitro diagnostic devices which require packaging, including labelling? FORMTEXT ?????3. In vitro diagnostic devices which require specific knowledge in examination procedures for the purpose of product verificationIVP CODEIn vitro diagnostic devices which require specific knowledge in examination proceduresSelectConditionsIVP 3001In vitro diagnostic devices which require knowledge regarding agglutination tests? FORMTEXT ?????IVP 3002In vitro diagnostic devices which require knowledge regarding biochemistry? FORMTEXT ?????IVP 3003In vitro diagnostic devices which require knowledge regarding chromatography? FORMTEXT ?????IVP 3004In vitro diagnostic devices which require knowledge regarding chromosomal analysis? FORMTEXT ?????IVP 3005In vitro diagnostic devices which require knowledge regarding coagulometry? FORMTEXT ?????IVP 3006In vitro diagnostic devices which require knowledge regarding flow cytometry? FORMTEXT ?????IVP 3007In vitro diagnostic devices which require knowledge regarding immunoassays? FORMTEXT ?????IVP 3008In vitro diagnostic devices which require knowledge regarding lysis based testing? FORMTEXT ?????IVP 3009In vitro diagnostic devices which require knowledge regarding measurement of radioactivity? FORMTEXT ?????IVP 3010In vitro diagnostic devices which require knowledge regarding microscopy? FORMTEXT ?????IVP 3011In vitro diagnostic devices which require knowledge regarding molecular biological testing including nucleic acid assays and next generation sequencing (NGS)? FORMTEXT ?????IVP 3012In vitro diagnostic devices which require knowledge regarding physical chemistry including electrochemistry? FORMTEXT ?????IVP 3013In vitro diagnostic devices which require knowledge regarding spectroscopy? FORMTEXT ?????IVP 3014In vitro diagnostic devices which require knowledge regarding tests of cell function? FORMTEXT ?????4. In vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verificationIVP CODEIn vitro diagnostic devices which require specific knowledge in laboratory and clinical disciplines for the purpose of product verificationSelectConditionsIVD 4001In vitro diagnostic devices which require knowledge regarding bacteriology? FORMTEXT ?????IVD 4002In vitro diagnostic devices which require knowledge regarding clinical chemistry / biochemistry? FORMTEXT ?????IVD 4003In vitro diagnostic devices which require knowledge regarding detection of transmissible agents (without organisms or viruses)? FORMTEXT ?????IVD 4004In vitro diagnostic devices which require knowledge regarding genetics? FORMTEXT ?????IVD 4005In vitro diagnostic devices which require knowledge regarding haematology / haemostasis, including coagulation disorders? FORMTEXT ?????IVD 4006In vitro diagnostic devices which require knowledge regarding histocompatibility and immunogenetics? FORMTEXT ?????IVD 4007In vitro diagnostic devices which require knowledge regarding immunohistochemistry / histology? FORMTEXT ?????IVD 4008In vitro diagnostic devices which require knowledge regarding immunology? FORMTEXT ?????IVD 4009In vitro diagnostic devices which require knowledge regarding molecular biology / diagnostics? FORMTEXT ?????IVD 4010In vitro diagnostic devices which require knowledge regarding mycology? FORMTEXT ?????IVD 4011In vitro diagnostic devices which require knowledge regarding parasitology? FORMTEXT ?????IVD 4012In vitro diagnostic devices which require knowledge regarding virology? FORMTEXT ????? ................
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