FantasticSearch

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 A INFORMATION TO BE SUBMITTED UPON THE REGISTRATION OF DEVICES AND ECONOMIC OPERATORS IN ACCORDANCE WITH ARTICLES 29(4) AND 31 Manufacturers or, when applicable, authorised representatives, and, when applicable, importers shall submit the information referred to in Section 1 and shall ensure that the information on their devices referred to in Section 2 is complete, correct and updated by the relevant party.

1. Information relating to the economic operator 1.1. type of economic operator(manufacturer, authorised representative, or importer), 1.2. name, address and contact details of the economic operator, 1.3. where submission of information is carried out by another person on behalf of any of the economic operators mentioned under Section 1.1, the name, address and contact details of that person,

1.4. name address and contact details of the person or persons responsible for regulatory compliance referred to in Article 15.

2. Information relating to the device 2.1. Basic UDI-DI, 2.2. type, number and expiry date of the certificate issued by the notified body and the name or identification number of that notified body and the link to the information that appears on the certificate and was entered by the notified body in the electronic system on notified bodies and certificates, 2.3. Member State in which the device is to or has been placed on the market in the Union, 2.4. in the case of class IIa, class IIb or class III devices: Member States where the device is or is to be made available, 2.5. risk class of the device, 2.6. reprocessed single-use device (y/n), 2.7. presence of a substance which, if used separately, may be considered to be a medicinal product and name of that substance, 2.8. presence of a substance which, if used separately, may be considered to be a medicinal product derived from human blood or human plasma and name of this substance, 2.9. presence of tissues or cells of human origin, or their derivatives (y/n),

4.10. Devices that are reusable shall bear a UDI carrier on the device itself. 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. The requirement of this Section shall not apply to devices in the following circumstances:

(a) any type of direct marking would interfere with the safety or performance of the device;

(b) the device cannot be directly marked because it is not technologically feasible.

4.11. The UDI carrier shall be readable during normal use and throughout the intended lifetime of the device.

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.

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.

4.14. The UDI carrier shall be placed in a manner such that the AIDC can be accessed during normal operation or storage.

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.

5. General principles of the UDI database 5.1. The UDI database shall support the use of all core UDI database data elements referred to in Part B of this Annex.

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.

5.3. Appropriate methods/procedures for validation of the data provided shall be implemented.

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.

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.

5.6. The database shall allow for the linking of all the packaging levels of the device.

5.7. The data for new UDI-DIs shall be available at the time the device is placed on the market.

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.

5.9. Internationally-accepted standards for data submission and updates shall, wherever possible, be used by the UDI database.

5.10. The user interface of the UDI database shall be available in all official languages of the Union. The use of free-text fields shall, however, be minimized in order to reduce translations.

5.11. Data relating to devices that are no longer available on the market shall be retained in the UDI database.

6. Rules for specific device types 6.1. Implantable devices: 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); 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.

6.1.3. The UDI of the implantable device shall be identifiable prior to implantation.

6.2. Reusable devices requiring cleaning, disinfection, sterilisation or refurbishing between uses 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.

6.2.2. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer.

6.3. Systems and procedure packs as referred to in Article 22 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.

6.3.2. Device contents of system or procedure packs shall bear a UDI carrier on their packaging or on the device itself. Exemptions:

(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;

(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.

6.3.3. Placement of the UDI carrier on systems or procedure packs (a) The system or procedure pack UDI carrier shall as a general rule be affixed to the outside of the packaging.

(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.

6.4. Configurable devices: 6.4.1. A UDI shall be assigned to the configurable device in its entirety and shall be called the configurable device UDI.

6.4.2. The configurable device UDI-DI shall be assigned to groups of configurations, not per configuration within the group. A group of configurations is defined as the collection of possible configurations for a given device as described in the technical documentation.

6.4.3. A configurable device UDI-PI shall be assigned to each individual configurable device.

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.

6.4.5. Each component that is considered a device and is commercially available on its own shall be assigned a separate UDI.

6.5. Device Software6.5.1. UDI assignment Criteria The UDI shall be assigned at the system level of the software. Only software which is commercially available on its own and software which constitutes a device in itself shall be subject to that requirement. The software identification shall be considered to be the manufacturing control mechanism and shall be displayed in the UDI-PI.

6.5.2. A new UDI-DI shall be required whenever there is a modification that changes:

(a) the original performance;

(b) the safety or the intended use of the software;

(c) interpretation of data. Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

6.5.3. Minor software revisions shall require a new UDI-PI and not a new UDI-DI. Minor software revisions are generally associated with bug fixes, usability enhancements that are not for safety purposes, security patches or operating efficiency. Minor software revisions shall be identified by a manufacturer-specific form of identification.

6.5.4. UDI placement criteria for software (a) where the software is delivered on a physical medium, e.g. CD or DVD, each packaging level shall bear the human readable and AIDC representation of the complete UDI. 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;

(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;

(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);

(d) only the human readable portion of the UDI shall be required in electronic displays of the software. The marking of UDI using AIDC shall not be required in the electronic displays, such as ‘about’ menu, splash screen etc.;

(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.

2.10. presence of tissues or cells of animal origin, or their derivatives, as referred to in Regulation (EU) No 722/2012 (y/n), 2.11. where applicable, the single identification number of the clinical investigation or investigations conducted in relation to the device or a link to the clinical investigation registration in the electronic system on clinical investigations, 2.12. in the case of devices listed in Annex XVI, specification as to whether the intended purpose of the device is other than a medical purpose, 2.13. in the case of devices designed and manufactured by another legal or natural person as referred in Article 10(15), the name, address and contact details of that legal or natural person, 2.14. in the case of class III or implantable devices, the summary of safety and clinical performance, 2.15. status of the device (on the market, no longer placed on the market, recalled, field safety corrective action initiated). PART B CORE DATA ELEMENTS TO BE PROVIDED TO THE UDI DATABASE TOGETHER WITH THE UDI-DI IN ACCORDANCE WITH ARTICLES 28 AND 29