{"text_format":"1","workbook":"xlsx","n_sheets":7,"sheets":["Questionnaire","IVR Codes","IVD Codes","IVP Codes","EMDN level 5","IVS Codes","."],"not_rendered":{"charts":0,"images":1,"macros":1,"external_links":2,"defined_names":11,"comments":0,"pivot_tables":0},"unopened":[],"bounds":{"document_bytes":16777216,"sheet_cells":100000,"rows_first":2000,"rows_last":500,"rows_between":2000,"halvings":0,"cell_chars":16384,"cell_head_chars":4096},"cells_cut":0,"cells_raw":0,"read":"whole","date_system":"1900"}

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[]
[null,"  Questions for Quoting - IVDR Module"]
[]
[null,"Please submit the completed questionnaire together with the document “Questions for Quoting - QMS Module”."]
[]
[]
[]
[null,"1. Details about the company and contact person(s)"]
[]
[null,"Legal company name:"]
[null,"E-Mail (contact person):"]
[]
[null,"Do you seek certification according to the activities described in Article 16?",null,null,"No",null,{"$f":"IF(E13=\"No\",\"\",IF(E13=\"Yes, as a manufacturer\",\"Modification of a device, already placed on the market or put into service.\",\"Implementation of provisions, including translation of the information supplied by the manufacturer                              Making changes to the outer packaging of a device already placed on the market, including a change of pack size/repackiging\"))","v":""}]
[]
[]
[]
[null,"2. Desired Conformity Assessment Procedure"]
[]
[null,"Risk Class",null,"Conformity Assessment Procedure (Please select below)"]
[null,"A (steril)"]
[null,"B"]
[null,"C"]
[null,"D"]
[]
[]
[]
[null,"3. Technical Documentations"]
[null,null,null,null,null,null,"Please specify:"]
[null,"Language of the technical documentation(s)",null,null,"Please select",null,null,null,"Prior approval of TRLP required"]
[null,"Did you receive consultancy regarding the implementation\nof your technical documentation(s)?",null,null,"Please select",null,"Please specify by whom and what was provided:"]
[]
[]
[]
[]
[null,"4. Product Information",null,"// Additional lines for further products will be shown automatically after you start typing a product name."]
[]
[null,0,null,null,null,null,"Classification of product and classification rule (highest risk class)",null,"EMDN code\n5th level "]
[null,"No.","Product Name or Trade Name\n(as listed on label) ","REF","Technical documentation identifier","Basic UDI-DI","Classification Rule including subclause acc. to Annex VIII","IVD class","European Medical Device Nomenclature (EMDN) (5th level)","IVR: device category","IVD:\nspecific knowledge in laboratory \nand clinical disciplines","IVP:\nspecific knowledge in examination procedures\n","IVS:\nspecific characteristics\nassign all codes applicable to the device","Intended Use\n(please shortly describe the intended use of your product)","interventional clinical performance study conducted (Annex XIV)","Devices in sterile condition","Multiple markers / analytes detected by the device to fullfil one specific intende use.\n\nNumber of additional markers ","Software that are devices in themselves \n(stand alone SW)","Devices incorporating software/utilising software \n(embedded SW) "]
[null,1,null,null,null,null,null,null,"please choose from above indicated link, e.g. \"W01010601\""]

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[]
[null,null,"Device Categories"]
[]
[null,101,"Devices intended to determine markers of the ABO system [A (ABO1), B (ABO2), AB (ABO3)]","Devices intended to be used for blood grouping"]
[null,102,"Devices intended to determine markers of the Rhesus system [RH1 (D), RHW1, RH2 (C), RH3 (E), RH4 (c), RH5 (e)]"]
[null,103,"Devices intended to determine markers of the Kell system [Kel1 (K)]"]
[null,104,"Devices intended to determine markers of the Kidd system [JK1 (Jka), JK2 (Jkb)]   \n     \n\n"]
[null,105,"Devices intended to determine markers of the Duffy system [FY1 (Fya), FY2 (Fyb)]"]
[null,106,"Other devices intended to be used for blood grouping"]
[null,201,"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","Devices intended to be used for tissue typing"]
[null,202,"Other devices intended to be used for tissue typing"]
[null,301,"Devices intended to be used in screening, diagnosis, staging or monitoring of cancer","Devices intended to be used for markers of cancer and non-malignant tumours"]
[null,302,"Other devices intended to be used for markers of cancer and non-malignant tumours"]
[null,401,"Devices intended to be used in screening/confirmation of congenital/inherited disorders","Devices intended to be used for human genetic testing"]
[null,402,"Devices intended to be used to predict genetic disease/disorder risk and prognosis"]
[null,403,"Other devices intended to be used for human genetic testing"]
[null,501,"Devices intended to be used for pre-natal screening of women in order to determine their immune status towards transmissible agents","Devices intended to be used to determine markers of infections/immune status"]
[null,502,"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"]
[null,503,"Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents"]
[null,504,"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"]
[null,505,"Devices intended to be used to grow/isolate/identify and handle infectious agents"]
[null,506,"Other devices intended to be used to determine markers of infections/immune status"]
[null,601,"Devices intended to be used for screening/confirmation of specific disorders/impairments","Devices intended to be used for non-infectious pathologies, physiological markers, disorders/impairments (except human genetic testing), and therapeutic measures"]
[null,602,"Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease"]
[null,603,"Devices intended to be used for screening, confirmation/determination, or monitoring of allergies and intolerances"]
[null,604,"Other devices intended to be used for a specific disease"]
[null,605,"Devices intended to be used for monitoring of levels of medicinal products, substances or biological components"]
[null,606,"Devices intended to be used for non-infectious disease staging"]
[null,607,"Devices intended to be used for detection of pregnancy or fertility testing"]
[null,608,"Devices intended to be used for screening, determination or monitoring of physiological markers"]
[null,609,"Other devices intended to be used to define or monitor physiological status and therapeutic measures"]
[null,701,"Devices which are controls without a quantitative assigned value","Devices which are controls without a quantitative or qualitative assigned value"]
[null,702,"Devices which are controls without a qualitative assigned value"]
[null,801,"Devices referred to in point 2.5 (rule 5), under a), of Annex VIII to Regulation (EU) 2017/746","Class A devices in sterile condition"]
[null,802,"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"]
[null,803,"Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746"]

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[]
[]
[null,"IVD Codes"]
[null,4001,"bacteriology"]
[null,4002,"clinical chemistry / biochemistry"]
[null,4003,"detection of transmissible agents (without organisms or viruses)"]
[null,4004,"genetics"]
[null,4005,"haematology / haemostasis, including coagulation disorders"]
[null,4006,"histocompatibility and immunogenetics"]
[null,4007,"immunohistochemistry / histology"]
[null,4008,"immunology"]
[null,4009,"molecular biology / diagnostics"]
[null,4010,"mycology"]
[null,4011,"parasitology"]
[null,4012,"virology"]

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[]
[]
[null,"IVP Codes"]
[null,3001,"Agglutination"]
[null,3002,"Biochemistry"]
[null,3003,"Chromatography"]
[null,3004,"Chromosomal analysis"]
[null,3005,"Coagulometry"]
[null,3006,"Flow cytometry"]
[null,3007,"Immunoassays"]
[null,3008,"Lysis based testing"]
[null,3009,"Measurement of radioactivity"]
[null,3010,"Microscopy"]
[null,3011,"Molecular biological testing including nucleic acid assays and next generation sequencing (NGS)"]
[null,3012,"Physical chemistry including electrochemistry"]
[null,3013,"Spectroscopy"]
[null,3014,"Tests of cell function"]

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[null,"CND CODE"]
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[null,"W05019099"]
[null,"W05020101"]
[null,"W05020102"]
[null,"W05020103"]
[null,"W05020104"]
[null,"W05020105"]
[null,"W05020106"]
[null,"W05020180"]
[null,"W05020199"]
[null,"W05030101"]
[null,"W05030102"]
[null,"W05030199"]
[null,"W05030201"]
[null,"W05030202"]
[null,"W05030301"]
[null,"W05030302"]
[null,"W05030380"]
[null,"W05030399"]
[null,"W05030401"]
[null,"W05030402"]
[null,"W05030480"]
[null,"W05030499"]
[null,"W05030501"]
[null,"W05030502"]
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[null,"W05039001"]
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{"sheet":"IVS Codes","index":5,"n_rows":13,"n_cols":4,"rows_kept":13,"cut":false,"hidden":false,"merged":[]}
[]
["1001 Devices intended to be used for near-patient testing"]
["1002 Devices intended to be used for self-testing",null,"IVS Codes"]
["1003 Devices intended to be used as companion diagnostics",null,1001,"Devices intended to be used for near-patient testing"]
["1004 Devices utilizing material of human origin",null,1002,"Devices intended to be used for self-testing"]
["1005 Devices in sterile condition",null,1003,"Devices intended to be used as companion diagnostics"]
["1006 Calibrators (Annex VIII 1.5)",null,1004,"Devices utilizing material of human origin"]
["1007 Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (Annex VIII 1.6)",null,1005,"Devices in sterile condition"]
["1008 Instruments, equipment, systems or apparatus",null,1006,"Calibrators (Annex VIII 1.5)"]
["1009 Software independent of any other device including software apps, software for data analysis, and for defining or monitoring therapeutic measures",null,1007,"Control materials with quantitative or qualitative assigned values intended for one specific analyte or multiple analytes (Annex VIII 1.6)"]
["1010 Devices incorporating software / utilising software / controlled by software",null,1008,"Instruments, equipment, systems or apparatus"]
[null,null,1009,"Software independent of any other device including software apps, software for data analysis, and for defining or monitoring therapeutic measures"]
[null,null,1010,"Devices incorporating software / utilising software / controlled by software"]

{"sheet":".","index":6,"n_rows":21,"n_cols":5,"rows_kept":21,"cut":false,"hidden":false,"merged":[[1,1,1,5]]}
[]
[null,"Conformity Assessment Procedures"]
[null,"A (sterile)","B","C","D"]
[null,"-","-","-","-"]
[null,"Annex IX (Full QMS)","Annex IX (Full QMS)","Annex IX (Full QMS)","Annex IX (Full QMS)"]
[null,"Annex II + III & Annex XI (Technical Documentation Assessment & Production Quality Assurance)",null,"Annex II + III & Annex XI (Technical Documentation Assessment & Production Quality Assurance)","Annex II + III & Annex XI (Technical Documentation Assessment & Production Quality Assurance)"]
[]
[]
[null,"Activities according to Article 16","Languages","TD Consultancy","Risk Classes"]
[null,"No","Please select","Please select","A (sterile)"]
[null,"Yes, as a manufacturer","German","No","B"]
[null,"Yes, as a distributor","English","Yes","B, self-testing"]
[null,"Yes, as an importer","Other EU Language",null,"B, near-patient testing"]
[null,null,null,null,"C"]
[null,null,null,null,"C, self-testing"]
[null,null,null,null,"C, near-patient testing"]
[null,null,null,null,"C, companion diagnostics"]
[null,"Checkboxes further information",null,null,"D"]
[null,"yes",null,null,"D, self-testing"]
[null,"no",null,null,"D, near-patient testing"]
[null,null,null,null,"D, companion diagnostics"]