{"text_format":"3","workbook":"xlsx","n_sheets":6,"sheets":["Overview","Guidance","Device Schedule","Sites","control","Rev History"],"not_rendered":{"images":2,"defined_names":6},"read":"whole","date_system":"1900"}

{"sheet":"Overview","index":0,"n_rows":9,"n_cols":2,"rows_kept":9,"merged":[[1,0,1,4],[3,1,3,4],[4,1,4,4],[5,1,5,4],[6,1,6,4],[7,0,7,4],[8,0,8,4]]}
[]
["To be completed by the manufacturer"]
[]
["Legal Manufacturer Name ","(populate here)"]
["Legal Manufacturer Address","(populate here)"]
["Contact Person","(populate here)"]
["Submission Date","(populate here)"]
["Please review the Guidance Tab before completing the Device Schedule Tab and Sites Tab"]
["Revision 8 (May 2021)"]

{"sheet":"Guidance","index":1,"n_rows":19,"n_cols":2,"rows_kept":19}
[]
[null,"Guidance for Device Schedule Tab"]
[]
[null,"Please include all devices applicable to your MDR application, including any devices already CE marked under the MDD/AIMDD. For CE marked devices, please list all relevant CE certificate numbers in Column B – Certificate Number(s) and provide copies of the certificates."]
[]
[null,"Column A - Application type - Select the requested type of application, MDR or UKCA, for each device listed. If applying for both forms of certification, list all devices to be covered by each scheme (i.e. all devices for MDR certification, followed by all devices for UKCA certification).\n"]
[null,"Column C - Device Nomenclature Code - EMDN coding (previously referred to as CND coding) has been selected by the EU Commission as the medical devices nomenclature system under MDR. EMDN codes may be obtained from the European Commission website - https://webgate.ec.europa.eu/dyna2/emdn/\n"]
[null,"Group different sizes and variants of the same product(s) in a single line item if the intended purpose for these sizes and variants is similar and these are covered by the same technical documentation.\n\nUse GMDN code (if available) for devices intended for UKCA certification.\n\nColumn E - Indications for Use as per the IFU - The Indications for Use statement should be detailed and should reflect what has been specified in the device Instructions for Use. For Class Ir devices, if being grouped using the EMDN coding system, a general intended purpose may be provided. For devices falling partially or wholly under Annex XVI of MDR, please clearly identify and separate the medical indications from the non-medical indications.\n\nColumn G - Classification - Select classification of the device from the drop-down list. \nWell-established technologies (WET) are referenced in Article 52(4), Article 52(5) of the Regulation and include devices such as sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors.\n\nColumn H - Justification for Classification - Manufacturers are required to provide detailed classification rationale(s) in order for the notified body/UK Approved Body to accurately assess the chosen rule(s) and the classification of the devices.\n\nColumn AA - Basic UDI-DI - Mandatory for registration and certification of devices under Regulation (EU) 2017/745 and therefore must be provided at the point of MDR application. Optional for UKCA applications.\n\nGuidance for Class Ir devices: \nClass Ir devices should be grouped using the EMDN codes for reusable surgical instruments (Category L under the EMDN coding system). Where available, grouping should be done at the level of 6 digits within category L (e.g. L010401 - Scissors, bandage and clothing; L031302 - Forceps, Dressing etc). The full list of Class Ir devices covered under each group should be maintained within the Manufacturer's own documentation and will be verified during BSI audits.\n\nFor each Class Ir row, a single primary functional category (cutting, drilling, sawing, scraping etc) that best describes the intended purpose of the instruments should be selected in Column H. If 'Other' is selected in Column H, Manufacturers should further define the functional category of the device(s) in Column I (e.g. probing, dilating). It is recommended to keep the number of class Ir functional categories to a minimum."]
[]
[null,"Guidance for Sites Tab"]
[]
[null,"The Sites tab should be populated with 4 site types where applicable. Site 1 should be populated with the Legal Manufacturer Main Site. The name and address field for this will be automatically populated based on the fields in the Overview tab. This should be populated as per the Manufacturers EUDAMED Submissions. Additional columns on the Sites tab should be populated with Manufacturer Additional Sites, Critical Subcontractors and Crucial Suppliers (where applicable).\n\nWhere the Sites tab requests copy of certificates, please provide copies of any CE Marking, ISO 13485, ISO 9001 or MDSAP certificates held."]
[]
[null,"Guidance on identifying a Critical Subcontractor"]
[null,"An organization that performs an outsourced process on Manufacturer's behalf and where the activity or service is critical to the performance and safety of the device(s).  This should include all significant subcontractors (i.e. as originally listed on the BSI Company Information  Form or current CE certificate listing) and any other entities previously unidentified."]
[null,"For example (but not limited to): Sterilisation services, primary packaging, forming services, assembly of final device, testing of final device, companies providing finished devices, regulatory responsibility and / or activities essential for ensuring compliance with legal requirements, design or software development."]
[null,"Guidance on identifying a Crucial Supplier"]
[null,"An organization that supplies a key raw material, or component, the failure of which to meet specified requirements could cause a significant degradation in the safety and performance of the device(s). "]
[null,"For example (but not limited to): Suppliers of key sub-assemblies or key components of a device. Suppliers of critical raw materials such as shell material & silicone gel component for breast implants or other silicone based implants, suppliers of animal tissue for animal-tissue based devices, medicinal substance suppliers or processors for device-drug combinations, polypropylene suppliers for implantable polypropylene based mesh devices, suppliers of metals and/or ceramics for replacement joints."]

{"sheet":"Device Schedule","index":2,"n_rows":1,"n_cols":29,"rows_kept":1}
["Application Type\n(select from dropdown)","Certificate Number(s)\n(list all relevant CE certificates)","Device Nomenclature Code as per EMDN (previously CND). \nFor Class Ir devices, where available, this must be specified in the following format: LXXXXXX.\nIf UKCA, provide GMDN code, if available.","Product Name \nList one manufacturer product name (brand name) per line. Product Group Name for Class Ir devices if being grouped using CND coding system.","Indications for Use as per the IFU\n(For Class Ir devices, if being grouped using the EMDN coding system, a general intended purpose may be provided. For devices falling partially or wholly under Annex XVI of MDR, please clearly identify and separate the medical indications from the non-medical indications.)","All applicable Classification Rules","Classification \n(select from the cell dropdown list)","Justification for Classification\n(Manufacturers are required to provide detailed classification rationale(s) in order for the notified body/UK Approved Body to accurately assess the chosen rule(s) and the classification of the devices.)","If Class Ir applies, select the functional category from the cell dropdown list","If the Class Ir functional category is 'Other' specify the functional category (e.g Dilating, Probing)","Is the device a new development to the market? \n(Yes/No)","Does the device feature any novel features such as materials, technologies or intended use? \n(Specify below or mark as 'Not applicable')","Materials: Indicate the primary material base/technology of the product.\n(Select from one of the following - Active non-implantable; Active Implantable; Non-active Plastic; Non-metal Mineral (e.g glass, ceramics); Non-metal non-mineral (e.g textiles, rubber, leather, paper); Biotechnology; Chemical Processing; Pharmaceuticals incorporated; Materials of Human or Animal origin; Non-active Metal; Software; Others (specify))","Is the product Sterile \n(Yes/No)","Sterilisation Method\n(ETO, Gamma, E-Beam, Dry Heat, etc or N/A)","Location of Sterilisation\n(Select from In-house, End-user, Subcontracted or N/A)","Cleaning Method - Class Ir only\n(choose from Manual Only, Automated Only, Manual or Automated, Manual AND Automated)","Does the device contain medicinal substances and/or human-blood derivatives?\n(If Yes, give details of medicinal substance including name, sourcing, availability of ASMF or CEP, previous consultations held with a national Competent Authority or EMA. If the substance is considered not to fall under MDD Rule 13 or MDR Rule 14, please provide a justification for this as a separate document. For Article 117 applications this justification is not required.\n\nIf No, specify 'Not applicable')","Does the device contain or utilise non viable animal tissue or derivatives?\n(If Yes, indicate the tissue/derivative, country of origin (sourcing country) and EDQM certificate details (if applicable).\n\nIf No, specify 'Not applicable')","Does the device utilise non viable human tissues, cells or derivatives? \n(If Yes, indicate the tissue/cell, sourcing, previous consultation held and any other relevant information.\n\nIf No, specify 'Not applicable')","Does the device utilise biologically active coatings and/or materials, and/or non-viable biological substances (bacterial or viral etc.)?\n(If Yes, specify the type of coating/materials.\n\nIf No, specify 'Not applicable')","Is the device wholly or mainly absorbed?\n(Yes/No)","Is the device locally dispersed in the human body or are intended to undergo a chemical change in the body? \n(Yes/No)","Does the device contain software (stand-alone or integrated)?\n(If Yes, specify the classification as per EN 62304 - Class A, B or C\n\nIf No, specify 'Not applicable') ","Does the device incorporate or consist of nanomaterials? \n(If Yes, specify the level of internal exposure (negligible; low; medium; high) of the nanomaterials. \n\nIf No, specify 'Not Applicable') ","Does the device include any accessories?\n(If Yes, specify the Accessories below and indicate if the accessories are sold with the device or separately.\n\nIf No, specify 'Not applicable')","Basic UDI-DI \n(Mandatory for MDR applications; for UKCA, specify 'Not applicable' if not available)","Date for Submission of Technical Documentation\n(select from the cell drop down list)","Technical Documentation File Reference Number"]

{"sheet":"Sites","index":3,"n_rows":13,"n_cols":101,"rows_kept":13}
["Sites","Site 1","Site 2","Site 3","Site 4","Site 5","Site 6","Site 7","Site 8","Site 9","Site 10","Site 11","Site 12","Site 13","Site 14","Site 15","Site 16","Site 17","Site 18","Site 19","Site 20","Site 21","Site 22","Site 23","Site 24","Site 25","Site 26","Site 27","Site 28","Site 29","Site 30","Site 31","Site 32","Site 33","Site 34","Site 35","Site 36","Site 37","Site 38","Site 39","Site 40","Site 41","Site 42","Site 43","Site 44","Site 45","Site 46","Site 47","Site 48","Site 49","Site 50","Site 51","Site 52","Site 53","Site 54","Site 55","Site 56","Site 57","Site 58","Site 59","Site 60","Site 61","Site 62","Site 63","Site 64","Site 65","Site 66","Site 67","Site 68","Site 69","Site 70","Site 71","Site 72","Site 73","Site 74","Site 75","Site 76","Site 77","Site 78","Site 79","Site 80","Site 81","Site 82","Site 83","Site 84","Site 85","Site 86","Site 87","Site 88","Site 89","Site 90","Site 91","Site 92","Site 93","Site 94","Site 95","Site 96","Site 97","Site 98","Site 99","Site 100"]
["Location Type (use the dropdown in this row to select the site type)","Legal Manufacturer Main Site"]
["Name",{"$f":"IF(Overview!B4=\"(populate here)\",\"Please populate this via the Overview Tab\", Overview!B4)","v":"Please populate this via the Overview Tab"}]
["Address",{"$f":"IF(Overview!B5=\"(populate here)\",\"Please populate this via the Overview Tab\", Overview!B5)","v":"Please populate this via the Overview Tab"}]
["Activities (specify the device(s) name and sterilization method, as applicable for each site/subcontractor)"]
["Number of Effective Employees"]
["Shift System (Hours/number of shifts/number of employees per shift)"]
["Site Contact (Name and Contact Details)"]
["Existing Registration(s)/Certification(s) held (Certificate Number and Type. List all applicable certificates.)"]
["Issuer(s) of Certificate(s)"]
["Copy of Certificate(s) Provided (Yes / No / N/A)"]
["Single Registration Number of Legal Manufacturer (MDR Article 52) if available"]
["Single Registration Number (MDR Article 22.3 Systems and Procedure Packs) if available"]

{"sheet":"control","index":4,"n_rows":27,"n_cols":13,"rows_kept":27,"hidden":true}
["Classification"]
["MDR","UKCA","Classification Ir",null,"Sub-contractors",null,null,"Tech doc readiness",null,null,"Application Type",null,"Yes/No"]
["Class I (Non-Sterile, Non-Measuring, Non-Reusable)","UKCA AIMD","Clamping",null,"Manufacturer Additional Site",null,null,"2021-01-01",null,null,"MDR",null,"Yes"]
["Class Im","UKCA MDD - Class Is","Clipping",null,"Critical Subcontractor",null,null,"2021-02-01",null,null,"UKCA",null,"No"]
["Class Im & Is","UKCA MDD - Class Im","Cutting",null,"Crucial Supplier",null,null,"2021-03-01"]
["Class Ir ","UKCA MDD - Class Is & Im","Drilling",{"$nulls":4},"2021-04-01"]
["Class Ir & Im","UKCA MDD - Class IIa","Retracting",{"$nulls":4},"2021-05-01"]
["Class Ir & Is ","UKCA MDD - Class IIb","Sawing",{"$nulls":4},"2021-06-01"]
["Class Ir & Is & Im","UKCA MDD - Class III","Scraping",{"$nulls":4},"2021-07-01"]
["Class Is",null,"Scratching",{"$nulls":4},"2021-08-01"]
["Class IIa - Non-Implantable",null,"Other",{"$nulls":4},"2021-09-01"]
["Class IIa - Implantable",{"$nulls":6},"2021-10-01"]
["Class IIb - rule 12",{"$nulls":6},"2021-11-01"]
["Class IIb - rule 12 - ARMS (administer and/or remove a medicinal substance)",{"$nulls":6},"2021-12-01"]
["Class IIb - Implantable - WET (Well-established Technologies as per Article 52.4 of MDR)",{"$nulls":6},"2022-01-01"]
["Class IIb - Implantable - non-WET",{"$nulls":6},"2022-02-01"]
["Class IIb - Non-Implantable - non-WET- non-Rule 12",{"$nulls":6},"2022-03-01"]
["Class IIb - Non-Implantable - non-WET- non-Rule 12 ARMS",{"$nulls":6},"2022-04-01"]
["Class III - Non-Implantable",{"$nulls":6},"2022-05-01"]
["Class III - Implantable",{"$nulls":6},"2022-06-01"]
["Custom-made Class III Implantable",{"$nulls":6},"2022-07-01"]
["Article 22.3 Systems and Procedure Packs",{"$nulls":6},"2022-08-01"]
["Article 117 Drug/Device Combinations",{"$nulls":6},"2022-09-01"]
[{"$nulls":7},"2022-10-01"]
[{"$nulls":7},"2022-11-01"]
[{"$nulls":7},"2022-12-01"]
[{"$nulls":7},"Q1 2023"]

{"sheet":"Rev History","index":5,"n_rows":27,"n_cols":5,"rows_kept":27,"hidden":true}
["Revision history"]
[]
["Revision","Date","Tab","Column","Changes"]
[7,"2021-01-01","Control","A","Added extra MDR device classifications: Class IIb - rule 12 - ARMS and Class Iib - Non-implantable - non-WET - non-Rule-12 ARMS"]
[7,"2021-01-01","Control","A","Added UKCA classifications"]
[7,"2021-01-01","Device Schedule","A","Added new column for application type (UKCA or MDR)"]
[7,"2021-01-01","Device Schedule","N/A","Added guidance for column A application type."]
[7,"2021-01-01","Device Schedule","B","Certificate column now requests all relevant CE certificates"]
[7,"2021-01-01","Device Schedule","C","Removed statement that EMDN codes are mandatory only for class IIb and Ir devices. GMDN code requested for UKCA devices."]
[7,"2021-01-01","Guidance","N/A","Removed statement that EMDN codes are mandatory only for class IIb and Ir devices. GMDN code requested for UKCA devices."]
[7,"2021-01-01","Device Schedule","D","Specified that one manufacturer product name (brand name) should be listed per line."]
[7,"2021-01-01","Device Schedule","E","Specified that Annex XVI refers to MDR"]
[7,"2021-01-01","Guidance","N/A","Specified that Annex XVI refers to MDR"]
[7,"2021-01-01","Device Schedule","F","Removed annex reference in classification rules column (MDD/AIMDD classifications will apply for UKCA)"]
[7,"2021-01-01","Device Schedule","H","Added reference to UK Approved Body"]
[7,"2021-01-01","Guidance","N/A","Added reference to UK Approved Body"]
[7,"2021-01-01","Device Schedule","I, J, Q, T","Added conditional formatting formula to grey out as non-applicable for all UKCA device classifications"]
[7,"2021-01-01","Device Schedule","O","Added Dry Heat as an extra example sterilization method"]
[7,"2021-01-01","Device Schedule","R","Added reference to MDD Rule 13"]
[7,"2021-01-01","Device Schedule","U","Added \"non-viable biological substances (bacterial or viral etc.)\""]
[7,"2021-01-01","Device Schedule","AA","Specified that Basic UDI-DI is mandatory for MDR not UKCA"]
[7,"2021-01-01","Sites","A","Added 'N/A' option for 'certificates provided' field to match MDF4300. Specified that Art. 52 SRN refers to SRN of Legal Manufacturer."]
[7,"2021-01-01","Sites","A","Added guidance to Activities field asking to specify device(s) and sterilization method(s) for sites"]
[7,"2021-01-01","Sites","A","Added guidance to \"Existing Registration(s)/Certification(s) held\" field asking to list all certificates"]
[7.1,"2021-02-01","Device Schedule","AB","Fixed formatting in column AB Date for Submission (formatted as date)"]
[8,"2021-05-01","Guidance","B7","Replaced link to Italian MoH CND page with link to EMDN codes on EC website"]
[8,"2021-05-01","Sites","AZ-CW","Added 50 additional sites"]