User Requirement Specification - RAS100.050 - Product Surveilance
| Requirement ID | Requirement description | Category | |
|---|---|---|---|
| 001 | It must be possible to assign for each device or product a specific DI number (Device Identifier). | CC | yes |
| 002 | It must be possible to assign a specific DI number to each standard Package Level. | CC | yes |
| 003 | For each DI number, the system must store the corresponding Issuing Agency, which is responsible for the Format of the DI No. | CC | yes |
| 004 | The recording of UDI data must be possible both on the basis of FDA requirements and on the basis of EU MDR requirements. For this purpose, different recording options must be available. | CC | yes |
| 005 | The FDA UDI-DI data record must be able to contain the following information: - 1-n brand names - a version or model number - the actual sales status - a catalog number - an alternative device description - base quantity per unit |
CC | yes |
| 006 | For each FDA UDI-DI data record the following properties must be able to be recorded: MRI safety status, allergen status, single use, prescription, OTC product, kit, combination product, HCT/P status, sterilized product, direct marking, risk class, active implant, measurement function, reuse status, reprocessing status. |
CC | yes |
| 007 | It must be possible to list possible side effects for each FDA UDI-DI data set. | CC | yes |
| 008 | For each FDA UDI-DI data set, the following additional or reference information must be available: - GMDN codes - Product Codes - FDA listing number - premarket submission - Registration numbers - Sterilization methods, if the product is marked as a sterile Product The additional information must be selectable from predefined code lists, if applicable. |
CC | yes |
| 009 | It must be possible to record information on clinical relevant sizes if required. For this purpose it is necessary to be able to store attribute values and units of measurement. It should be possible to group the respective attribute values. | CC | yes |
| 010 | It must be possible to create packaging structures with an independent UDI-DI. For this purpose, it must be possible to enter the following information: - DI number - UDI-DI included in the package - quantity of the containing UDI-DI - type of packaging |
CC | yes |
| 011 | It must be possible to specify storage conditions for each device or product. For this the system must allow the input of the storage environment property, if necessary a minium / maximum value, as well as the unit of measurement. For special storage conditions, text entries must be possible. | CC | yes |
| 012 | According to EU-MDR, it must be possible to assign a basic UDI-DI and the associated information for similar articles. - application legislation (MDR or IVDR), UDI-DI, allocation office, manufacturer SRN, contact details of the manufacturer |
CC | yes |
| 013 | The system must support the recording of basic UDI-DI data in that the following entries are possible when creating a data set of the type "Standard": - Product Risk Class, Implantability, Measurement Function, Active Device, Reusability, Purpose for Drug Administration / Disposal, Reference Number, Device Name / Model - presence of human tissue/cells, presence of animal tissue/cells, statement on the origin of the product from human blood or plasma - special device / product types |
CC | yes |
| 014 | The system must support the acquisition of basic UDI-DI data in that the following entries are possible when creating a data set of the type "System or Procedure Pack": - Specification if the device is a System or Procedure Pack - System or Procedure Pack manufacturer (SPPP SRN), - Risk Class, Device Name / Model Name - medical purpose of the product |
CC | yes |
| 015 | If the Basic UDI-DI falls under the Invitro Diagnostic Regulation, it must be possible to record the following additional criteria: - Indication if it is a specific product (software, soft contact lenses etc.) - Indication if the product is part of a kit (if so, indication of the kit affiliation) - SRN of the manufacturer - Authorized representative - Device Name / Model Name - IVDR Risk Class - presence of human tissue/cells, presence of animal tissue/cells, statement on the origin of the product from human blood or plasma - statements on microbial substances, reagent, accompanying diagnostics, instrument - statements on the type of use (Near Patient Testing, Professional Testing, Patient - Self-Testing) |
CC | yes |
| 016 | It must be possible to reference clinical investigation numbers in a BASIC UDI DI data set. | CC | yes |
| 017 | For a BASIC UDI-DI data set it must be possible to reference certificates with information about certificate number, revision, type and validity. | CC | yes |
| 018 | If the medical device is a standard product, it must be possible to record the following DI information for the specific device: - general data: UDI language code, issuing Agency, DI number, allocation to BASE UDI, product/device name, catalog number, product description, base quantity - different (second) issuing Agency, different (second) DI-No. - Information on direct marking (direct marking, issuing Angency for direct marking, DI number for direct marking) - Sales / distribution status, CND / MDN code - Traceability Information or Production Identifier: Lot Number Specific, Serial Number Specific, Expiration Date required, Production Date required, Software Version required - Other features: sold sterile or sterilization required before use, reuse or single use, includes latex, - Information according to Annex XVI - Member state of placing on the EU market (market information) |
CC | yes |
| 019 | If it is a standard product and not a System or Procedure Pack, the following information must also be listed: - clinical sizes - CMR or endocrine disruptors (CAS number, EC number, type) - medical substances (INN, type) - critical warnings / side effects |
CC | yes |
| 020 | If the medical device is a system or procedure pack, the following information must be available. - general data: UDI language code, issuing agency, DI number, allocation to UDI, product/device name, catalog number, product description, - different (second) issuing Agency, different (second) DI number - Sales / distribution status, CND / MDN code - Traceability Information or Production Identifier: Batch Number specific, Serial Number specific, Expiration Date required, Production Date required, Software Version required - Other features: sold as a sterile product or sterilization required before use - critical warnings |
CC | yes |
| 021 | It must be possible that the function for releasing UDI data can only be used by certain users. It must be possible to set up permissions at status level. | CC | yes |
| 022 | When releasing UDI data, appropriate plausibility checks must be performed in accordance with the EU-MDR / FDA implementation guidelines. The system prevents the release of a data set if corresponding plausibility checks are not fulfilled. These plausibility checks must check the filling of mandatory fields and context-related plausibilities. | CC | yes |
| 023 | The input of all UDI-DI information in accordance with FDA and EU-MDR must be possible at both item or item/variant level. | CC | yes |
| 024 | When entering UDI-DI data at variant level, it must be possible to transfer the data from the article-related UDI-DI data record to the variant using a copy function. | CC | yes |
| 025 | It must be possible to print one UDI label per production order. It must be possible to print one label per serial / batch number. | CC | yes |
| 026 | The coding of the print data must support the GS1 and HIBC standard. | CC | yes |
| 027 | When printing labels, the system also supports the output of standardized medical symbols and markings according to ISO 15223-1. | CC | yes |