AIDC — Automatic identification and data capture

A technology used to automatically capture data. AIDC technologies include bar codes, smart cards, biometrics and RFID.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Basic UDI-DI — Basic UDI device identifier

The primary identifier of a device model. It is the DI assigned at the level of the device unit of use. It is the main key for records in the UDI database and is referenced in relevant certificates and EU declarations of conformity.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Configuration

A combination of items of equipment, as specified by the manufacturer, that operate together as a device to achieve an intended purpose. The combination of items may be modified, adjusted or customized to meet specific needs. Configurations include inter alia: — gantries, tubes, tables, consoles and other items of equipment that can be configured/combined to deliver an intended function in computed tomography. — ventilators, breathing circuits, vaporizers combined to deliver an intended function in anaesthesia.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Configurable device

A device that consists of several components which can be assembled by the manufacturer in multiple configurations. Those individual components may be devices in themselves. Configurable devices include computed tomography (CT) systems, ultrasound systems, anaesthesia systems, physiological Monitoring systems, radiology information systems (RIS).

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

HRI — Human readable interpretation

A legible interpretation of the data characters encoded in the UDI carrier.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Packaging levels

The various levels of device packaging that contain a defined quantity of devices, such as a carton or case.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

RFID — Radio frequency identification

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.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Shipping container

A container in relation to which traceability is controlled by a process specific to logistics systems.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

UDI — Unique Device Identifier

A series of numeric or alphanumeric characters that is created through internationally accepted device identification and coding standards and that allows unambiguous identification of specific devices on the market.

Reference: MDR Article 2(15); IVDR Article 2(15)

UDI carrier

The means of conveying the UDI by using AIDC and, if applicable, its HRI. UDI carriers include, inter alia, ID/linear bar code, 2D/Matrix bar code, RFID. 2. General requirements 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. 2.2. The manufacturer shall assign and maintain unique UDIs for its devices. 2.3. Only the manufacturer may place the UDI on the device or its packaging. 2.4. Only coding standards provided by issuing entities designated by the Commission pursuant to Article 27(2) may be used. 3. The UDI 3.1. A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI. 3.2. Shipping containers shall be exempted from the requirement in Section 3.1. 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. 3.3. The UDI shall contain two parts: a UDI-DI and a UDI-PI. 3.4. The UDI-DI shall be unique at each level of device packaging. 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. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. 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. 3.7. Systems and procedure packs as referred to in Article 22 shall be assigned and bear their own UDI. 3.8. The manufacturer shall assign the UDI to a device following the relevant coding standard. 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: (a) name or trade name, (b) device version or model, (c) labelled as single use, (d) packaged sterile, (e) need for sterilization before use, (f) quantity of devices provided in a package, (g) critical warnings or contra-indications: e.g. containing latex or DEHP. 3.10. Manufacturers that repackage and/or relabel devices, with their own label shall retain a record of the original device manufacturer's UDI. 4. UDI carrier 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. Higher levels do not include shipping containers. 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. 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. 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.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

UDI-DI — UDI device identifier

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.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

UDI-PI — UDI production identifier

A numeric or alphanumeric code that identifies the unit of device production. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of date.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1

Unit of Use DI — Unit of Use device identifier

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.

Reference: MDR Annex VI Part C Section 1; IVDR Annex VI Part C Section 1