Our glossary for guidance - Letter U

With the Unique Device Identification, medical devices are made uniformly identifiable worldwide. The obligation to use the UDI number was laid down in the Medical Devices Regulation (MDR), which has been in force since 26 May 2021. A transition period was granted for in vitro diagnostic devices. Since 26 May 2022, the labelling obligation with the UDI number also applies to these products.

Shortcut for Unique Device Identification Device Identifier.

[Definition of terms according to MDCG 2020-13 Acronyms and MDCG 2019-9 Abbreviations]

Independent Flight Attendants Organisation.

‘Unique Device Identifier’ (‘UDI’) means 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.

[Definition under (EU) 2017/745 Article 2 No. 15 also corresponds to definition under (EU) 2017/746 Article 2 No. 15]

Shortcut for Uniform Resource Locator = internet address

[Definition of terms according to MDCG 2019-9 Abbreviations]

Application of knowledge about human behaviour, abilities, limitations, and other characteristics to the design of and interactions with an IVD medical devices (including software) to achieve adequate usability.
Source: Modified from IEC 62366

[Definition according to MDCG 2022-2 No. 4]

Characteristic of the user interface that facilitates use and thereby establishes effectiveness, efficiency and user satisfaction in the intended use environment.

Note 1 to entry: all aspects of usability, including effectiveness, efficiency and user satisfaction, can either increase or decrease safety. Source: IEC 62366:2015

[Definition according to MDCG 2022-2 No. 4]

Actual conditions and setting in which users interact with the IVDs (e.g. self-tests).

[Definition according to MDCG 2022-2 No. 4]

‘User’ means any healthcare professional or lay person who uses a device.

[Definition according to (EU) 2017/746 Article 2 No. 30]

‘User’ means any healthcare professional or lay person who uses a device;         

[Definition according to (EU) 2017/745 Article 2 No. 37]

USP is an acronym for "Unique Selling Proposition or Unique Selling Point" and describes the unique selling proposition of a product, brand, institution or company.