Trend reporting

The obligation to report any statistically significant increase in the frequency or severity of incidents that are not themselves serious, or of expected undesirable side-effects, where that increase could materially affect the benefit-risk determination.

Reference: MDR Article 88; IVDR Article 83

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

Up-classification

A device moving to a higher risk class under the regulation than it held under the directives, usually because of a changed or newly added classification rule. The consequence is a different conformity assessment route and, often, notified body involvement where there was none before.

Reference: MDR Annex VIII

User

Any healthcare professional or lay person who uses a device.

Reference: MDR Article 2(37); IVDR Article 2(30)

Vigilance — Vigilance reporting

The reporting of serious incidents and field safety corrective actions to competent authorities within prescribed deadlines, followed by investigation and, where needed, corrective action. Distinct from post-market surveillance, which is the wider ongoing data-gathering activity.

Reference: MDR Article 87; IVDR Article 82

WET — Well-established technology

A mature technology for which extensive, long-standing experience exists. The MDR does not define the term, but uses the concept in two places: exempting certain class IIb implantable devices from device-by-device technical documentation assessment, and exempting certain implantable and class III devices from the requirement to conduct clinical investigations.

Reference: MDR Article 52(4) and Article 61(6)(b)

Withdrawal

Any measure aimed at preventing a device in the supply chain from being further made available on the market.

Reference: MDR Article 2(63); IVDR Article 2(66)