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MDRQ #2122

MDRQ #2073: ANNEX VI INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31, CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29, AND THE UDI SYSTEM

PART C: THE UDI SYSTEM

Added by Anonymous over 6 years ago. Updated over 4 years ago.

Status:
Released
Priority:
Low

Description

PART C: THE UDI SYSTEM

Subissues

MDRQ #2123: 1. DefinitionsReleasedActions
MDRQ #2124: Automatic identification and data capture ('AIDC')ReleasedActions
MDRQ #2125: AIDC is a technology used to automatically capture data.ReleasedActions
MDRQ #2126: AIDC technologies include bar codes, smart cards, biometrics and RFID.ReleasedActions
MDRQ #2127: Basic UDI-DIReleasedActions
MDRQ #2128: The Basic UDI-DI is the primary identifier of a device model.ReleasedActions
MDRQ #2129: It is the DI assigned at the level of the device unit of use.ReleasedActions
MDRQ #2130: It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.ReleasedActions
MDRQ #2131: Unit of Use DIReleasedActions
MDRQ #2132: The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labelled on the individual device at the level of its unit of use, for example in the event of several units of the same device being packaged together.ReleasedActions
MDRQ #2133: Configurable deviceReleasedActions
MDRQ #2134: A configurable device is a device that consists of several components which can be assembled by the manufacturer in multiple configurations.ReleasedActions
MDRQ #2135: Those individual components may be devices in themselves.ReleasedActions
MDRQ #2136: Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).ReleasedActions
MDRQ #2137: ConfigurationReleasedActions
MDRQ #2138: Configuration is a combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose.ReleasedActions
MDRQ #2139: The combination of items may be modified, adjusted or customized to meet specific needs.ReleasedActions
MDRQ #2140: Configurations include inter alia:ReleasedActions
MDRQ #2141: ' gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography.ReleasedActions
MDRQ #2142: ' ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.ReleasedActions
MDRQ #2143: UDI-DIReleasedActions
MDRQ #2144: The UDI-DI is a unique numeric or alphanumeric code specific to a model of device and that is also used as the 'access key' to information stored in a UDI database.ReleasedActions
MDRQ #2145: Human Readable Interpretation ('HRI')ReleasedActions
MDRQ #2146: HRI is a legible interpretation of the data characters encoded in the UDI carrier.ReleasedActions
MDRQ #2147: Packaging levelsReleasedActions
MDRQ #2148: Packaging levels means the various levels of device packaging that contain a defined quantity of devices, such as a carton or case.ReleasedActions
MDRQ #2149: UDI-PIReleasedActions
MDRQ #2150: The UDI-PI is a numeric or alphanumeric code that identifies the unit of device production.ReleasedActions
MDRQ #2151: The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.ReleasedActions
MDRQ #2152: Radio Frequency Identification RFIDReleasedActions
MDRQ #2153: RFID is a technology that uses communication through the use of radio waves to exchange data between a reader and an electronic tag attached to an object, for the purpose of identification.ReleasedActions
MDRQ #2154: Shipping containersReleasedActions
MDRQ #2155: A shipping container is a container in relation to which traceability is controlled by a process specific to logistics systems.ReleasedActions
MDRQ #2156: Unique Device Identifier ('UDI')ReleasedActions
MDRQ #2157: The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard.ReleasedActions
MDRQ #2158: It allows the unambiguous identification of a specific device on the market.ReleasedActions
MDRQ #2159: The UDI is comprised of the UDI-DI and the UDI-PI.ReleasedActions
MDRQ #2160: The word 'Unique' does not imply serialisation of individual production units.ReleasedActions
MDRQ #2161: UDI carrierReleasedActions
MDRQ #2162: The UDI carrier is the means of conveying the UDI by using AIDC and, if applicable, its HRI.ReleasedActions
MDRQ #2163: UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID.ReleasedActions
MDRQ #2164: 2. General requirementsReleasedActions
MDRQ #2165: 2.1. The affixing of the UDI is an additional requirement ' it does not replace any other marking or labelling requirements laid down in Annex I to this Regulation.ReleasedActions
MDRQ #2166: 2.2. The manufacturer shall assign and maintain unique UDIs for its devices.ReleasedActions
MDRQ #2167: 2.3. Only the manufacturer may place the UDI on the device or its packaging.ReleasedActions
MDRQ #2168: 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used.ReleasedActions
MDRQ #2169: 3. The UDIReleasedActions
MDRQ #2170: 3.1. A UDI shall be assigned to the device itself or its packaging.ReleasedActions
MDRQ #2171: Higher levels of packaging shall have their own UDI.ReleasedActions
MDRQ #2172: 3.2. Shipping containers shall be exempted from the requirement in Section 3.1.ReleasedActions
MDRQ #2173: By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.ReleasedActions
MDRQ #2174: 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI.ReleasedActions
MDRQ #2175: 3.4. The UDI-DI shall be unique at each level of device packaging.ReleasedActions
MDRQ #2176: 3.5. If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI.ReleasedActions
MDRQ #2177: If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI.ReleasedActions
MDRQ #2178: If there is only a manufacturing date on the label, this shall be used as the UDI-PI.ReleasedActions
MDRQ #2179: 3.6. Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.ReleasedActions
MDRQ #2180: 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI.ReleasedActions
MDRQ #2181: 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard.ReleasedActions
MDRQ #2182: 3.9. A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:ReleasedActions
MDRQ #2183: a) name or trade nameReleasedActions
MDRQ #2184: (b) device version or model,ReleasedActions
MDRQ #2185: (c) labelled as single use,ReleasedActions
MDRQ #2186: (e) need for sterilization before use,ReleasedActions
MDRQ #2187: (f) quantity of devices provided in a package,ReleasedActions
MDRQ #2188: (g) critical warnings or contra-indications: e.g. containing latex or DEHP.ReleasedActions
MDRQ #2189: 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI.ReleasedActions
MDRQ #2190: 4. UDI carrierReleasedActions
MDRQ #2191: 4.1. The UDI carrier (AIDC and HRI representation of the UDI) shall be placed on the label or on the device itself and on all higher levels of device packaging.ReleasedActions
MDRQ #2192: Higher levels do not include shipping containers.ReleasedActions
MDRQ #2193: 4.2. In the event of there being significant space constraints on the unit of use packaging, the UDI carrier may be placed on the next higher packaging level.ReleasedActions
MDRQ #2194: 4.3. For single-use devices of classes I and IIa packaged and labelled individually, the UDI carrier shall not be required to appear on the packaging but it shall appear on a higher level of packaging, e.g. a carton containing several individually packaged devices.ReleasedActions
MDRQ #2195: However, when the healthcare provider is not expected to have access, in cases such as in home healthcare settings, to the higher level of device packaging, the UDI shall be placed on the packaging of the individual device.ReleasedActions
MDRQ #2196: 4.4. For devices exclusively intended for retail point of sale the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.ReleasedActions
MDRQ #2197: 4.5. When AIDC carriers other than the UDI carrier are part of the product labelling, the UDI carrier shall be readily identifiable.ReleasedActions
MDRQ #2198: 4.6. If linear bar codes are used, the UDI-DI and UDI-PI may be concatenated or non-concatenated in two or more bar codes.ReleasedActions
MDRQ #2199: All parts and elements of the linear bar code shall be distinguishable and identifiable.ReleasedActions
MDRQ #2200: 4.7. If there are significant constraints limiting the use of both AIDC and HRI on the label, only the AIDC format shall be required to appear on the label.ReleasedActions
MDRQ #2201: For devices intended to be used outside healthcare facilities, such as devices for home care, the HRI shall however appear on the label even if this results in there being no space for the AIDC.ReleasedActions
MDRQ #2202: 4.8. The HRI format shall follow the rules of the UDI code-issuing entity.ReleasedActions
MDRQ #2203: 4.9. If the manufacturer is using RFID technology, a linear or 2D bar code in line with the standard provided by the issuing entities shall also be provided on the label.ReleasedActions
MDRQ #2204: 4.10. Devices that are reusable shall bear a UDI carrier on the device itself.ReleasedActions
MDRQ #2205: The UDI carrier for reusable devices that require cleaning, disinfection, sterilisation or refurbishing between patient uses shall be permanent and readable after each process performed to make the device ready for the subsequent use throughout the intended lifetime of the device.ReleasedActions
MDRQ #2206: The requirement of this Section shall not apply to devices in the following circumstances:ReleasedActions
MDRQ #2207: (a) any type of direct marking would interfere with the safety or performance of the device;ReleasedActions
MDRQ #2208: (b) the device cannot be directly marked because it is not technologically feasible.ReleasedActions
MDRQ #2209: 4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.ReleasedActions
MDRQ #2210: 4.12. If the UDI carrier is readily readable or, in the case of AIDC, scannable, through the device's packaging, the placing of the UDI carrier on the packaging shall not be required.ReleasedActions
MDRQ #2211: 4.13. In the case of single finished devices made up of multiple parts that must be assembled before their first use, it shall be sufficient to place the UDI carrier on only one part of each device.ReleasedActions
MDRQ #2212: 4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.ReleasedActions
MDRQ #2213: 4.15. Bar code carriers that include both a UDI-DI and a UDI-PI may also include essential data for the device to operate or other data.ReleasedActions
MDRQ #2214: 5. General principles of the UDI databaseReleasedActions
MDRQ #2215: 5.1. The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.ReleasedActions
MDRQ #2216: 5.2. Manufacturers shall be responsible for the initial submission and updates of the identifying information and other device data elements in the UDI database.ReleasedActions
MDRQ #2217: 5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.ReleasedActions
MDRQ #2218: 5.4. Manufacturers shall periodically verify the correctness of all of the data relevant to devices they have placed on the market, except for devices that are no longer available on the market.ReleasedActions
MDRQ #2219: 5.5. The presence of the device UDI-DI in the UDI database shall not be assumed to mean that the device is in conformity with this Regulation.ReleasedActions
MDRQ #2220: 5.6. The database shall allow for the linking of all the packaging levels of the device.ReleasedActions
MDRQ #2221: 5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.ReleasedActions
MDRQ #2222: 5.8. Manufacturers shall update the relevant UDI database record within 30 days of a change being made to an element, which does not require a new UDI-DI.ReleasedActions
MDRQ #2223: 5.9. Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.ReleasedActions
MDRQ #2224: 5.10. The user interface of the UDI database shall be available in all official languages of the Union.ReleasedActions
MDRQ #2225: The use of free-text fields shall, however, be minimized in order to reduce translations.ReleasedActions
MDRQ #2226: 5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.ReleasedActions
MDRQ #2227: 6. Rules for specific device typesReleasedActions
MDRQ #2228: 6.1. Implantable devices:ReleasedActions
MDRQ #2229: 6.1.1. Implantable devices shall, at their lowest level of packaging ('unit packs'), be identified, or marked using AIDC, with a UDI (UDI-DI + UDI-PI);ReleasedActions
MDRQ #2230: 6.1.2. The UDI-PI shall have at least the following characteristics: (a) the serial number for active implantable devices, (b) the serial number or lot number for other implantable devices.ReleasedActions
MDRQ #2231: 6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.ReleasedActions
MDRQ #2232: 6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between usesReleasedActions
MDRQ #2233: 6.2.1. The UDI of such devices shall be placed on the device and be readable after each procedure to make the device ready for the next use.ReleasedActions
MDRQ #2234: 6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.ReleasedActions
MDRQ #2235: 6.3. Systems and procedure packs as referred to in Article 22ReleasedActions
MDRQ #2236: 6.3.1. The natural or legal person referred to in Article 22 shall be responsible for identifying the system or procedure pack with a UDI including both UDI-DI and UDI-PI.ReleasedActions
MDRQ #2237: 6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself.ReleasedActions
MDRQ #2238: Exemptions:ReleasedActions
MDRQ #2239: (a) individual single-use disposable devices, the uses of which are generally known to the persons by whom they are intended to be used, which are contained within a system or procedure pack, and which are not intended for individual use outside the context of the system or procedure pack, shall not be required to bear their own UDI carrier;ReleasedActions
MDRQ #2240: (b) devices that are exempted from bearing a UDI carrier on the relevant level of packaging shall not be required to bear a UDI carrier when included within a system or procedure pack.ReleasedActions
MDRQ #2241: 6.3.3. Placement of the UDI carrier on systems or procedure packsReleasedActions
MDRQ #2242: (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.ReleasedActions
MDRQ #2243: (b) The UDI carrier shall be readable, or, in the case of AIDC, scannable, whether placed on the outside of the packaging of the system or procedure pack or inside transparent packaging.ReleasedActions
MDRQ #2244: 6.4. Configurable devices:ReleasedActions
MDRQ #2245: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.ReleasedActions
MDRQ #2246: 6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group.ReleasedActions
MDRQ #2247: A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.ReleasedActions
MDRQ #2248: 6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.ReleasedActions
MDRQ #2249: 6.4.4. The carrier of the configurable device UDI shall be placed on the assembly that is most unlikely to be exchanged during the lifetime of the system and shall be identified as the configurable device UDI.ReleasedActions
MDRQ #2250: 6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.ReleasedActions
MDRQ #2251: 6.5. Device SoftwareReleasedActions
MDRQ #2252: 6.5.1. UDI assignment CriteriaReleasedActions
MDRQ #2253: The UDI shall be assigned at the system level of the software.ReleasedActions
MDRQ #2254: Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement.ReleasedActions
MDRQ #2255: The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.ReleasedActions
MDRQ #2256: 6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:ReleasedActions
MDRQ #2257: (a) the original performance;ReleasedActions
MDRQ #2258: (b) the safety or the intended use of the software;ReleasedActions
MDRQ #2259: (c) interpretation of data.ReleasedActions
MDRQ #2260: Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.ReleasedActions
MDRQ #2261: 6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI.ReleasedActions
MDRQ #2262: Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency.ReleasedActions
MDRQ #2263: Minor software revisions shall be identified by a manufacturer-specific form of identification.ReleasedActions
MDRQ #2264: 6.5.4. UDI placement criteria for softwareReleasedActions
MDRQ #2265: (a) where the software is delivered on a physical medium, e.g.ReleasedActions
MDRQ #2266: CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI.ReleasedActions
MDRQ #2267: The UDI that is applied to the physical medium containing the software and its packaging shall be identical to the UDI assigned to the system level software;ReleasedActions
MDRQ #2268: (b) the UDI shall be provided on a readily accessible screen for the user in an easily-readable plain-text format, such as an 'about' file, or included on the start-up screen;ReleasedActions
MDRQ #2269: (c) software lacking a user interface such as middleware for image conversion, shall be capable of transmitting the UDI through an application programming interface (API);ReleasedActions
MDRQ #2270: (d) only the human readable portion of the UDI shall be required in electronic displays of the software.ReleasedActions
MDRQ #2271: The marking of UDI using AIDC shall not be required in the electronic displays, such as 'about' menu, splash screen etc.;ReleasedActions
MDRQ #2272: (e) the human readable format of the UDI for the software shall include the Application Identifiers (AI) for the standard used by the issuing entities, so as to assist the user in identifying the UDI and determining which standard is being used to create the UDI.ReleasedActions

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