A1: Manufacturer/UKRP/Authorised Representative (Northern Ireland only) Registration B1: Mandatory/Optional C1: Field Type D1: Validation E1: Editable after registration? F1: Fee Payable to update after registration?
A2: Account number B2: Mandatory C2: System generated D2: NA E2: No F2: NA
A3: Organisation name B3: Mandatory C3: Free text D3: Max 200 characters E3: Yes F3: No
A4: Address line 1 B4: Mandatory C4: Free text D4: Max 200 characters E4: Yes F4: No
A5: Address line 2 (optional) B5: Optional C5: Free text D5: Max 200 characters E5: Yes F5: No
A6: Address line 3 (optional) B6: Optional C6: Free text D6: Max 200 characters E6: Yes F6: No
A7: Address line 4 (optional) B7: Optional C7: Free text D7: Max 200 characters E7: Yes F7: No
A8: Town/City B8: Mandatory C8: Free text D8: Max 100 characters E8: Yes F8: No
A9: County/State/Province (optional) B9: Mandatory C9: Free Text D9: Max 100 characters E9: Yes F9: No
A10: Country B10: Mandatory C10: Select from England, Scotland, Wales, Northern Ireland D10: NA E10: Yes F10: No
A11: Post/Zip code B11: Mandatory C11: Free text D11: Max 20 characters E11: Yes F11: No
A12: Website address (optional) B12: Optional C12: Select D12: Max 100 characters E12: Yes F12: No
A13: Customer Service Contact - Email address (optional) - appears on PARD, if populated B13: Optional C13: Free Text D13: Max 250 characters E13: Yes F13: No
A14: Customer Service Contact - Telephone no. (optional) - appears on PARD, if populated B14: Optional C14: Free Text D14: Max 50 Characters including + and () E14: Yes F14: No
A15: Company type (values: limited, sole trader, business partnership) B15: Mandatory C15: Select D15: NA E15: No F15: Email device.registrations@mhra.gov.uk if Company type needs to be changed
A16: Organisation role (values: Manufacturer, UK Responsible Person, AR (NI only)) B16: Mandatory C16: Select D16: NA E16: Yes F16: Fee applies to register each represented manufacturer and role will update automatically
A17: Email address B17: Mandatory C17: Free text D17: Max 250 characters E17: Yes F17: No
A18: Title (optional) - (e.g. Person creating account) B18: Optional C18: Select D18: NA E18: Yes F18: No
A19: First name B19: Mandatory C19: Free text D19: Max 100 characters E19: Yes F19: No
A20: Last name B20: Mandatory C20: Free text D20: Max 100 characters E20: Yes F20: No
A21: Job title B21: Optional C21: Select D21: Max 250 characters E21: Yes F21: No
A22: Telephone number (Please enter your phone number without any spaces) B22: Mandatory C22: Free text D22: Max 50 characters E22: Yes F22: No
A23: What is your primary reason for requesting an MHRA account? B23: Mandatory C23: Select D23: All applications related to registering medical devices and ordering Certificates of Free Sale for medical devices E23: No F23: N/A
A24: Companies house registration number B24: Optional C24: Free text D24: Max 30 characters E24: No F24: N/A
A25: VAT B25: Optional C25: Free text D25: Max 30 characters E25: No F25: N/A
A26: EU SRN (if allocated) B26: Optional C26: Free text D26: Max 50 characters E26: Yes F26: No
A27: Add Manufacturer By AR/UKRP - Represented Organisations
A28: Organisation name B28: Mandatory C28: Free text D28: Max 200 characters E28: Yes F28: No
A29: Describe your organisation by selecting up to three options below. e.g. B29: Mandatory for Represented manufacturer. Mandatory for UK accounts at point of updating organisation details. C29: Select D29: Dental Laboratory Dental Surgery/Clinic Manufacturer of disability devices Ophthalmology organisation Maxillofacial technology organisation Manufacturer of prosthetic devices Manufacturer of orthodontic devices Sterilisation unit/institution Manufacturer of medical device software Other Assembler E29: Yes F29: No
A30: I wish to represent this manufacturer as UKRP or AR (for NI only) B30: Mandatory C30: Select D30: NA E30: No F30: Yes - New registration required. Fee applies to register each represented manufacturer and role will update automatically
A31: Address line 1 B31: Mandatory C31: Free text D31: Max 200 characters E31: Yes F31: No
A32: Address line 2 (optional) B32: Optional C32: Free text D32: Max 200 characters E32: Yes F32: No
A33: Address line 3 (optional) B33: Optional C33: Free text D33: Max 200 characters E33: Yes F33: No
A34: Address line 4 (optional) B34: Optional C34: Free text D34: Max 200 characters E34: Yes F34: No
A35: Town/City B35: Mandatory C35: Free text D35: Max 100 characters E35: Yes F35: No
A36: County/State/Province (optional) B36: Optional C36: Free text D36: Max 100 characters E36: Yes F36: No
A37: Country B37: Mandatory C37: Select from Country list per Foreign, Commonwealth and Development Office Country names index D37: NA E37: Yes F37: No
A38: Postcode B38: Mandatory C38: Free text D38: Max 20 characters E38: Yes F38: No
A39: Telephone B39: Mandatory C39: Free text D39: Max 50 characters E39: Yes F39: No
A40: Fax (optional) B40: Optional C40: Free text D40: Max 50 digits E40: Yes F40: No
A41: Website (optional) B41: Optional C41: Free text D41: Max 100 characters E41: Yes F41: No
A42: Customer Service Contact - Email address (optional) - appears on PARD, if populated B42: Optional C42: Free Text D42: Max 250 characters E42: Yes F42: No
A43: Customer Service Contact - Telephone no. (optional) - appears on PARD, if populated B43: Optional C43: Free Text D43: Max 50 Characters including + and () E43: Yes F43: No
A44: Title (optional) B44: Optional C44: Select D44: NA E44: Yes F44: No
A45: First name (Contact at represented organisation) B45: Mandatory C45: Free text D45: Max 100 characters E45: Yes F45: No
A46: Last name (Contact at represented organisation) B46: Mandatory C46: Free text D46: Max 100 characters E46: Yes F46: No
A47: Job title (optional) (Contact at represented organisation) B47: Optional C47: Select D47: NA E47: Yes F47: No
A48: Email (Contact at represented organisation) B48: Mandatory C48: Free text D48: Max 250 characters E48: Yes F48: No
A49: Telephone number (Contact at represented organisation) B49: Mandatory C49: Free text D49: Max 50 characters E49: Yes F49: No
A50: Upload Letter of Designation - for Represented manufacturers only B50: Mandatory C50: Upload doc, .docx, .pdf, .jpg, .tif, .png, .odt D50: File max 15MB E50: Yes F50: No
A51: Description of document B51: Optional C51: Free text D51: Max 255 characters E51: Yes F51: No
A1: Importer details (can only be added by UKRP or Authorised Representative in Northern Ireland) B1: Mandatory/Optional C1: Field Type D1: Validation E1: Editable after associated? F1: Fee Payable to update after association?
A2: Account number B2: Mandatory C2: System generated D2: NA E2: No F2: N/A
A3: Organisation name B3: Mandatory C3: Free text D3: 200 characters E3: No F3: No changes permitted to any fields. To make changes, deactivate importer and add again - no fees apply.
A4: Associated with Importer as UKRP or Authorised Representative (NI only)? B4: Mandatory C4: Select D4: NA E4: No F4: No
A5: This importer is associated with the following manufacturers B5: Mandatory C5: Select from list of Registered manufacturers D5: NA E5: No F5: No
A6: Address line 1 B6: Mandatory C6: Free text D6: Max 200 characters E6: No F6: No
A7: Address line 2 (optional) B7: Optional C7: Free text D7: Max 200 characters E7: No F7: No
A8: Address line 3 (optional) B8: Optional C8: Free text D8: Max 200 characters E8: No F8: No
A9: Address line 4 (optional) B9: Optional C9: Free text D9: Max 200 characters E9: No F9: No
A10: Town/City B10: Mandatory C10: Free text D10: Max 100 characters E10: No F10: No
A11: County/State/Province B11: Optional C11: Free text D11: Max 100 characters E11: No F11: No
A12: Country B12: Mandatory C12: Select from England, Scotland, Wales, Northern Ireland D12: NA E12: No F12: No
A13: Postcode B13: Mandatory C13: Free text D13: Max 20 characters E13: No F13: No
A14: Telephone B14: Mandatory C14: Free text D14: Max 50 characters E14: No F14: No
A15: Fax B15: Optional C15: Free text D15: Max 50 characters E15: No F15: No
A16: Website address B16: Optional C16: Free text D16: Max 100 characters E16: No F16: No
A17: Importer Contact Details:
A18: Title B18: Optional C18: Select D18: NA E18: No F18: No
A19: First name B19: Mandatory C19: Free text D19: Max 100 characters E19: No F19: No
A20: Last name B20: Mandatory C20: Free text D20: Max 100 characters E20: No F20: No
A21: Job title B21: Optional C21: Free text D21: Max 250 characters E21: No F21: No
A22: Email B22: Mandatory C22: Free text D22: Max 250 characters E22: No F22: No
A23: Telephone number B23: Mandatory C23: Free text D23: Max 50 Characters including + and () E23: No F23: No
A1: General Medical Device B1: Mandatory/Optional C1: Field Type D1: Validation E1: Editable after registration? F1: Fee Payable to update after registration?
A2: GMDN® Code or Term B2: Mandatory C2: GMDN® Code or predictive text for Term D2: Will only accept active 5 digit GMDN® Code or Term from daily GMDN® feed E2: Only editable for obsolete GMDN® Codes & Terms F2: No
A3: Is it custom made? B3: Mandatory C3: Yes/No D3: NA E3: No F3: NA
A4: What risk classification applies to this device? B4: Mandatory C4: Select D4: NA E4: No F4: NA
A5: Which directive/regulation does this device comply with? B5: Mandatory C5: Radio button D5: UK MDR 2002 (SI 2002 No 618 as amended), Part II Directive 93/42/EEC European medical device regulations (EU) 2017/745 E5: No F5: NA
A6: If Class I
A7: Are any of the products related to this device measuring? B7: Mandatory C7: Yes/No D7: NA E7: No F7: NA
A8: Device labelled as sterile? B8: Mandatory C8: Yes/No D8: NA E8: No F8: NA
A9: If Yes: Select Method of sterilisation B9: Mandatory C9: Select D9: Radiation Gamma or Electron Beam Ethylene Oxide Steam Dry Heat Chemical Other E9: No F9: NA
A10: If: Other B10: Mandatory C10: Free text D10: Max 50 characters E10: No F10: NA
A11: Single-use device? B11: Mandatory C11: Yes/No D11: NA E11: No F11: NA
A12: If No: The maximum number of reuses (if applicable) B12: Mandatory C12: Free text D12: Max 50 characters E12: No F12: NA
A13: Is it intended for single patient use? B13: Mandatory C13: Yes/No D13: NA E13: No F13: NA
A14: Reprocessed single-use device? B14: Mandatory C14: Yes/No D14: NA E14: No F14: NA
A15: If Class IIa, IIb or III all of the above plus:
A16: Are any of the products related to this device implantable? B16: Mandatory C16: Yes/No D16: NA E16: No F16: NA
A17: Reusable surgical instruments (For EU 2017/745 non-implantable devices only) B17: Mandatory C17: Yes/No D17: NA E17: No F17: NA
A18: Are any of the products related to this device active? B18: Mandatory C18: Yes/No D18: NA E18: No F18: NA
A19: Device intended to administer and/or remove medicinal product? B19: Mandatory C19: Yes/No D19: NA E19: No F19: NA
A20: If device complies with EU 2017/745 is intended purpose other than medical (Annex XVI)? B20: Mandatory C20: Yes/No D20: It Yes, select from: Contact lenses or other items intended to be introduced into or onto the eye Products intended to be totally or partially introduced in the human body Substances, combinations of substances, or items intended for filling by injection Equipment intended to be used to reduce, remove or destroy adipose tissue High intensity electromagnetic radiation Brain electrostimulation E20: No F20: NA
A21: The following apply to all device classes
A22: Basic UDI-DI Issuing Entity B22: Optional C22: Select D22: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E22: No if field populated Yes if field empty F22: No
A23: Basic UDI-DI B23: Mandatory if entity selected C23: Free text D23: GS1 AISBL - Max 25 characters HIBCC - Max 25 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E23: No if field populated Yes if field empty F23: No
A24: Presence of a substance which, if used separately, may be considered to be a medicinal/herbal medicinal B24: Optional C24: Yes/No D24: NA E24: No if field populated Yes if field empty F24: No
A25: If yes: INN code (optional) Substance name (mandatory), multiples can be added B25: Optional C25: Free text D25: Max 100 characters E25: No if field populated Yes if field empty F25: No
A26: Presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma B26: Optional C26: Yes/No D26: NA E26: No if field populated Yes if field empty F26: No
A27: If yes: INN code (optional) Substance name (mandatory), multiples can be added B27: Optional C27: Free text D27: Max 100 characters E27: No if field populated Yes if field empty F27: No
A28: Has a Clinical investigation been conducted? (Yes/No) - multiple clinical investigation details can be added B28: Optional C28: Yes/No D28: NA E28: Yes F28: No
A29: if Clinical investigation is conducted: Country in which Clinical investigation is conducted B29: Optional C29: Select D29: NA E29: Yes F29: No
A30: if Clinical investigation is conducted: MHRA reference number – for UK studies B30: Optional C30: Free text D30: Max 50 characters E30: Yes F30: No
A31: if Clinical investigation is conducted: IRAS number – for UK studies B31: Optional C31: Free text D31: Max 50 characters E31: Yes F31: No
A32: if Clinical investigation is conducted: Short Title and Version Number of the Study – for all studies B32: Optional C32: Free text D32: Max 100 characters E32: Yes F32: No
A33: if Clinical investigation is conducted: Clinical Investigation Plan Code Number – for all studies B33: Optional C33: Free text D33: Max 50 characters E33: Yes F33: No
A34: URL link for Summary of Safety and Clinical Performance Applies to B34: Optional C34: Free text D34: Max 2000 characters E34: Yes F34: No
A35: Date SSCP last updated B35: Mandatory if URL link entered C35: Date D35: Date can not be a future date E35: Yes F35: No
A36: Conformity Assessment Certificate/ Declaration of Conformity/Custom-made Statement
A37: Upload Self-certification conformity declarations: Declaration of Conformity – Class I medical devices that do not require certification by a UK Approved Body or EU Notified Body i.e. non-sterile, non-measuring, non-reprocessed. Custom-Made Statement – All custom-made devices. Declaration for all system or procedure packs and assemblers – to UK MDR 2002 Regulation14 or Article 12 of Directive 93/42/EEC or Article 22 of EU Regulation 2017/745. B37: Mandatory C37: Upload doc, .docx, .pdf, .jpg, .tif, .png, .odt D37: File max 15MB E37: Yes F37: No
A38: Certificate type (Conformity Assessment certificates only) B38: Mandatory C38: Select D38: Will only accept type that matches device legislation E38: Yes F38: No
A39: Expiry date (Conformity Assessment certificates only) B39: Mandatory C39: Select D39: Cannot be date less than next day E39: Yes F39: No
A40: Certificate/Document reference number B40: Mandatory C40: Free text D40: Max 100 characters - no characters other than hyphen (-) or underscore (_) E40: Yes F40: No
A41: UK Approved Body or EU Notified Body designation B41: Mandatory C41: Select D41: UKCA-UK MDR 2002 - Part II/Part III/Part IV CE-MDD/IVDD/AIMD CE-MDR/IVDR CE UKNI - MDR/IVDR E41: Yes F41: No
A42: Select UK Approved Body or EU Notified Body (Conformity Assessment certificates only) B42: Mandatory C42: Select D42: Select from dropdown list E42: Yes F42: No
A43: Product (UDI-DI)
A44: Medical Device Name (Brand/Trade/Proprietary or Common name) B44: Mandatory C44: Free text D44: Max 255 characters E44: No F44: NA
A45: Model/Version B45: Mandatory C45: Free text D45: Max 100 characters E45: No F45: NA
A46: Catalogue/Reference (Ref) - this is SKU or your internal reference B46: Mandatory C46: Free text D46: Max 255 characters E46: Yes F46: No
A47: UDI Issuing Entity B47: Optional C47: Radio button D47: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E47: No if field populated Yes if field empty F47: No
A48: UDI Device Identifier (UDI-DI) B48: Mandatory if Entity selected C48: Free text D48: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E48: No if field populated Yes if field empty F48: No
A49: Unit of use UDI-DI B49: Optional D49: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E49: No if field populated Yes if field empty F49: No
A50: Is the Device directly Marked with UDI-DI? B50: Optional C50: Yes/No D50: NA E50: No if field populated Yes if field empty F50: No
A51: If Yes: Direct Marking DI different from UDI-DI B51: Optional C51: Yes/No D51: NA E51: No if field populated Yes if field empty F51: No
A52: If Yes: Direct Marking DI number B52: Optional C52: Text box D52: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E52: No if field populated Yes if field empty F52: No
A53: Package DI Number B53: Optional C53: Yes/No D53: NA E53: No if field populated Yes if field empty F53: No
A54: Package DI Number level1 B54: Optional C54: Text box D54: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E54: No if field populated Yes if field empty F54: No
A55: Package Type level1 e.g. case/box B55: Optional C55: Text box D55: Max 500 characters E55: No if field populated Yes if field empty F55: No
A56: Package DI Number level2 B56: Optional C56: Text box D56: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E56: No if field populated Yes if field empty F56: No
A57: Package Type level2 e.g. case/box B57: Optional C57: Text box D57: Max 500 characters E57: No if field populated Yes if field empty F57: No
A58: Package DI Number level3 B58: Optional C58: Text box D58: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E58: No if field populated Yes if field empty F58: No
A59: Package Type level3 e.g. case/box B59: Optional C59: Text box D59: Max 500 characters E59: No if field populated Yes if field empty F59: No
A60: Product Status (on which market) B60: Mandatory C60: Select D60: On the GB & NI market On the NI market On the GB market No longer placed on the GB or NI market Not intended to be placed on GB or NI market (for CFS only) E60: Yes F60: No
A61: If Product No Longer Placed on the GB or NI Market - enter End of Commercial Distribution Date B61: Mandatory C61: Select E61: Yes F61: No
A62: URL for additional information (such as electronic instructions for use) B62: Optional C62: Free text D62: Max 300 characters E62: Yes F62: No
A63: Type of UDI-PI (select one or multiples) B63: Optional C63: Select D63: Lot or Batch number Serial Number Manufacturing Date Expiration Date Software Version E63: Yes F63: No
A64: Does the device incorporate human cells or tissues, or their derivatives (Yes/No) B64: Optional C64: Yes/No D64: NA E64: No if field populated Yes if field empty F64: No
A65: Does the device incorporate animal cells or tissues, or their derivatives (Yes/No) B65: Optional C65: Yes/No D65: NA E65: No if field populated Yes if field empty F65: No
A66: Are storage/handling conditions specified in the label/instructions for use (Yes/No) B66: Optional C66: Yes/No D66: NA E66: No if field populated Yes if field empty F66: No
A67: Description of storage/handling conditions (e.g. temperature range, needs to be refrigerated, relative humidity range, pressure range, avoid direct sunlight, as applicable) B67: Optional C67: Free text D67: Max 300 characters E67: Yes F67: No
A68: Quantity per package configuration B68: Optional C68: Numeric D68: Max 10 digits E68: No if field populated Yes if field empty F68: No
A69: Need for sterilisation before use (Yes/No) B69: Optional C69: Yes/No D69: NA E69: No if field populated Yes if field empty F69: No
A70: If Yes: Select Method of sterilisation B70: Mandatory if Yes selected C70: Select D70: Radiation Gamma or Electron Beam Ethylene Oxide Steam Dry Heat Chemical Other E70: No if field populated Yes if field empty F70: No
A71: If: Other enter sterilisation method B71: Mandatory if Yes & Other selected C71: Free text D71: Max 50 characters E71: No if field populated Yes if field empty F71: No
A72: What MRI safety information does the labelling contain B72: Optional C72: Select D72: MR Safe MR Conditional MR Unsafe Labelling does not contain MRI safety information E72: Yes F72: No
A73: Does the label/instruction for use include Critical warnings or contra-indications (Yes/No) B73: Optional C73: Yes/No D73: NA E73: Yes F73: No
A74: If Yes: Description of Critical warnings or contra-indications B74: Optional C74: Free text D74: Max 300 characters E74: Yes F74: No
A75: Containing latex B75: Optional C75: Yes/No D75: NA E75: No if field populated Yes if field empty F75: No
A76: Clinical size applicable (yes/no) B76: Optional C76: Yes/No D76: NA E76: No if field populated Yes if field empty F76: No
A77: If Clinical size is applicable: additional info textbox (e.g. measurement, dimensions, range etc.) B77: Optional C77: Free text D77: Max 300 characters E77: No if field populated Yes if field empty F77: No
A78: Secondary UDI Issuing Entity (optional) B78: Optional C78: Yes/No D78: N/A E78: No if field populated Yes if field empty F78: No
A79: Secondary UDI Issuing Entity B79: Mandatory is Yes selected C79: Select D79: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E79: No if field populated Yes if field empty F79: No
A80: Secondary UDI Device Identifier (UDI-DI)(if assigned) B80: Mandatory if Yes and Entity selected C80: Free text D80: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E80: No if field populated Yes if field empty F80: No
A81: Endocrine disruptor (example DEHP ) B81: Optional C81: Yes/No D81: NA E81: No if field populated Yes if field empty F81: No
A82: Additional product description B82: Optional C82: Free text D82: Max 500 characters E82: Yes F82: No
A83: Active Implantable Medical Device (AIMD) UK MDR 2002 (SI 2002 No 618 as amended), Part III or Directive 90/385/EEC
A84: Same fields list apply to AIMD as for General Medical Device except no risk class and for custom-made AIMD we require IFU and label B84: Per General Medical Device Fields
A85: AIMD - Label and IFU B85: Mandatory C85: Upload doc, .docx, .pdf, .jpg, .tif, .png, .odt D85: File max 15MB E85: Yes F85: No
A86: Custom-made devices
A87: Same fields apply for Custom-made devices except no class for devices added under the directives B87: Per General Medical Device Fields
A88: System and Procedure Pack (SPP)
A89: Same fields apply for System and Procedure Pack as for General Medical Device except no risk class and following additional questions and requirement to upload content list B89: Per General Medical Device Fields
A90: Does the System or Procedure Pack incorporate a custom-made medical device that is not required to bear a UKCA/CE/CE (UK NI) marking? B90: Mandatory C90: Yes/No D90: NA E90: No F90: NA
A91: Does the system or procedure pack incorporate a medical device that does not bear a UKCA/ CE/ CE(UK NI) marking? B91: Mandatory C91: Yes/No D91: NA E91: No F91: NA
A92: Are the chosen combination of medical devices compatible in view of their original intended use? B92: Mandatory C92: Yes/No D92: NA E92: No F92: NA
A93: SPP content list document B93: Mandatory C93: Upload Template D93: Template must contain minimum two products E93: Yes F93: No
A1: in vitro Diagnostic Medical Device B1: Mandatory/Optional C1: Field Type D1: Validation E1: Editable after registration? F1: Fee Payable to update after registration?
A2: GMDN® Code or Term B2: Mandatory C2: GMDN® Code or predictive text for Term D2: Will only accept active 5 digit GMDN® Code or Term from daily GMDN® feed E2: Only editable for obsolete GMDN® Codes & Terms F2: No
A3: Which directive/regulation does this device comply with? B3: Mandatory C3: Radio button D3: UK MDR 2002 (SI 2002 No 618 as amended), Part IV Directive 98/79/EC European in vitro diagnostic medical device regulations (EU) 2017/746 E3: No F3: NA
A4: What risk classification applies to this device? B4: Mandatory C4: Select D4: NA E4: No F4: NA
A5: If UK MDR 2002 (SI 2002 No 618 as amended), Part IV or Directive 98/79/EC B5: Mandatory C5: Radio button D5: IVD Annex II List A IVD Annex II List B IVD Devices for Self-Testing IVD General E5: No F5: NA
A6: If European in vitro diagnostic medical device regulations (EU) 2017/746: B6: Mandatory C6: Radio button D6: Class A Class B Class B – Self-testing or Near-patient Testing Class C Class C – Companion Diagnostics Class C – Self-testing or Near-patient Testing Class D Class D – Companion Diagnostics Class D – Self-testing or Near-patient Testing E6: No F6: NA
A7: Are any of the products related to this device sterile? (EU 2017/746 only) B7: Mandatory C7: Yes/No D7: NA E7: No F7: NA
A8: Basic UDI-DI Issuing Entity B8: Optional C8: Select D8: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E8: No if field populated Yes if field empty F8: No
A9: Basic UDI-DI B9: Mandatory if Entity selected C9: Free text D9: GS1 AISBL - Max 25 characters HIBCC - Max 25 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E9: No F9: NA
A10: Is this device subject to performance evaluation studies? B10: Mandatory C10: Yes/No D10: NA E10: No F10: NA
A11: Conformity Assessment Certificate/ Declaration of Conformity
A12: Upload a new Conformity Assessment Certificate or Declaration of Conformity or Declaration for Performance Evaluation Statement to UK MDR 2002 Regulation 43 or Annex VIII of Directive 98/79/EC or Part A of Annex XIII of EU regulation 2017/746. B12: Mandatory C12: Upload doc, .docx, .pdf, .jpg, .tif, .png, .odt D12: File max 15MB E12: Yes F12: No
A13: Certificate type (Conformity Assessment certificates only) B13: Mandatory C13: Select D13: Will only accept type that matches device legislation E13: Yes F13: No
A14: Expiry date (Conformity Assessment certificates only) B14: Mandatory C14: Select D14: Cannot be date less than next day E14: Yes F14: No
A15: Certificate/Document reference number B15: Mandatory C15: Free text D15: Max 100 characters - no characters other than hyphen (-) or underscore (_) E15: Yes F15: No
A16: UK Approved Body or EU Notified Body designation B16: Mandatory C16: Select D16: UKCA-UK MDR 2002 - Part II/Part III/Part IV CE-MDD/IVDD/AIMD CE-MDR/IVDR CE UKNI - MDR/IVDR E16: Yes F16: No
A17: Select UK Approved Body or EU Notified Body (Conformity Assessment certificates only) B17: Mandatory C17: Select D17: Select from dropdown list E17: Yes F17: No
A18: Product (model or version detail)
A19: Medical Device Name (Brand/Trade/Proprietary or Common name) B19: Mandatory C19: Free text D19: Max 255 characters E19: No F19: NA
A20: Device model (model or version detail) B20: Mandatory C20: Free text D20: Max 100 characters E20: No F20: NA
A21: Catalogue/Reference (Ref) - this is SKU or your internal reference B21: Optional C21: Free text D21: Max 255 characters E21: Yes F21: No
A22: UDI Issuing Entity (optional) B22: Optional C22: Radio button D22: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E22: No if field populated Yes if field empty F22: No
A23: UDI Device Identifier (UDI-DI) B23: Mandatory if Entity selected C23: Free text D23: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E23: No if field populated Yes if field empty F23: No
A24: Unit of use UDI-DI B24: Optional D24: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E24: No if field populated Yes if field empty F24: No
A25: Is the Device directly Marked with UDI-DI? B25: Optional C25: Yes/No D25: NA E25: No if field populated Yes if field empty F25: No
A26: If Yes: Direct Marking DI different from UDI-DI B26: Optional C26: Yes/No D26: NA E26: No if field populated Yes if field empty F26: No
A27: If Yes: Direct Marking DI number B27: Optional C27: Text box D27: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E27: No if field populated Yes if field empty F27: No
A28: Package DI Number B28: Optional C28: Yes/No D28: NA E28: No if field populated Yes if field empty F28: No
A29: Package DI Number level1 B29: Optional C29: Text box D29: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E29: No if field populated Yes if field empty F29: No
A30: Package Type level1 e.g. case/box B30: Optional C30: Text box D30: Max 500 characters E30: No if field populated Yes if field empty F30: No
A31: Package DI Number level2 B31: Optional C31: Text box D31: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E31: No if field populated Yes if field empty F31: No
A32: Package Type level2 e.g. case/box B32: Optional C32: Text box D32: Max 500 characters E32: No if field populated Yes if field empty F32: No
A33: Package DI Number level3 B33: Optional C33: Text box D33: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E33: No if field populated Yes if field empty F33: No
A34: Package Type level3 e.g. case/box B34: Optional C34: Text box D34: Max 500 characters E34: No if field populated Yes if field empty F34: No
A35: Product Status (on which market) B35: Mandatory C35: Select D35: On the GB & NI market On the NI market On the GB market No longer on the GB or NI market Not intended to be placed on GB or NI market (for CFS only) For Performance Evaluation Only E35: Yes F35: No
A36: Is this product subject to performance evaluation studies? B36: Mandatory C36: Yes/No D36: NA E36: No F36: NA
A37: Is this product new to the market? B37: Mandatory C37: Yes/No D37: NA E37: No F37: NA
A38: Does this product conform to the common technical specification (CTS)? B38: Mandatory C38: Yes/No D38: NA E38: No F38: NA
A39: If Yes conform to CTS - enter CTS reference B39: Mandatory C39: Free text D39: Max 306 characters E39: No F39: NA
A40: If No conform to CTS - enter how have demonstrated compliance with Annex I and describe testing B40: Mandatory C40: Free text D40: Max 255 characters E40: No F40: NA
A41: URL for additional information (such as electronic instructions for use) B41: Optional C41: Free text D41: Max 300 characters E41: Yes F41: No
A42: Type of UDI-PI (select one or multiples) B42: Optional C42: Select D42: Lot or Batch number Serial Number Manufacturing Date Expiration Date Software version E42: No if field populated Yes if field empty F42: No
A43: Does the device incorporate human cells or tissues, or their derivatives (Yes/No) B43: Optional C43: Yes/No D43: NA E43: No if field populated Yes if field empty F43: No
A44: Does the device incorporate animal cells or tissues, or their derivatives (Yes/No) B44: Optional C44: Yes/No D44: NA E44: No if field populated Yes if field empty F44: No
A45: Are storage/handling conditions specified in the label/instructions for use (Yes/No) B45: Optional C45: Yes/No D45: NA E45: No if field populated Yes if field empty F45: No
A46: Description of storage/handling conditions (e.g. Temperature range, needs to be refrigerated, relative humidity range, pressure range, avoid direct sunlight as applicable) B46: Optional C46: Free text D46: Max 300 characters E46: Yes F46: No
A47: Quantity per package configuration B47: Optional C47: Numeric D47: Max 10 digits E47: No if field populated Yes if field empty F47: No
A48: Does the label/instruction for use include Critical warnings or contra-indications (Yes/No) B48: Optional C48: Yes/No D48: NA E48: Yes F48: No
A49: Description of Critical warnings or contra-indications B49: Optional C49: Free text D49: Max 300 characters E49: Yes F49: No
A50: Secondary UDI Issuing Entity (optional) B50: Optional C50: Yes/No D50: NA E50: No if field populated Yes if field empty F50: No
A51: Secondary UDI Issuing Entity B51: Mandatory if Yes Selected C51: Select D51: GS1 AISBL HIBCC ICCBBA IFA GmbH UDI not assigned E51: No if field populated Yes if field empty F51: No
A52: Secondary UDI Device Identifier (UDI-DI)(if assigned) B52: Mandatory if Entity selected C52: Free text D52: GS1 AISBL - Length should be 14 digits. Check digit validation is implemented. HIBCC - 6 to 23 characters ICCBBA - Max 50 characters IFA GmbH - Max 50 characters E52: No if field populated Yes if field empty F52: No
A53: Endocrine disruptor B53: Optional C53: Yes/No D53: NA E53: No if field populated Yes if field empty F53: No
A54: Additional product description B54: Optional C54: Free text D54: Max 500 characters E54: Yes F54: No