20+ important terms about MDR/UDI

20 important terms about MDR/UDI

The medical device industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By enforcing such complex regulations, there is a need for clarity on what´s meant by the various terms. Alone in the numerous provisions of the UDI regulations, many expressions need to be known. We have summarized 20 important terms about MDR/UDI you should know to ease your transition.


Automatic Identification and Data Capture. This term covers identification techniques, data acquisition, data collection, and data transmission, such as barcodes and RFID. It is used for the automatic identification of, in this case, medical technology products.


One of the machine-readable variants in which the code can be applied.

Basis UDI-DI

It is the primary identifier of a product model. It forms a bracket, so to speak, for different variants of a medical device.

Data Matrix Code

One of the machine-readable variants in which the code can be applied.

Device Identifier (DI)

One of two components of the UDI. This is the product identification and serves to uniquely identify the medical technology product. Alphanumerically or numerically structured, it is static and ISO-based. It also contains the master data. Each UDI-DI is assigned to exactly one basic UDI-DI.


By May 2020, the products must already be assigned a UDI-PI, otherwise, the product may not be placed on the market. The UDI must also be applicable to the products differs depending on the product class. -> See product labeling obligation.

Economic Operator

These include manufacturer, an authorized representative, an importer, a distributor, or the person referred to in Articles 22(1) and 22(3).


It’s the central database to which the reports must be sent. The original launch date of the database is May 2020. Due to the lack of functionality of most modules, the launch date was postponed to May 2022.


Theoretically, it is possible to keep the data and UDI in an Excel list. The data can be reported manually to EUDAMED. However, this procedure is only suitable for manufacturers with very few products.

Falsified Device

This refers to any device with a false presentation of its identity and/or its source and/or its CE marking certificates or documents relating to CE marking procedures. The definition does not include unintentional non-compliance and is without prejudice to infringements of intellectual property rights.

Generic Device Group

It describes a set of devices that have the same or similar intended purpose or commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.


The Human Readable Interpretation. The information must also be printed in plain text on the packaging.


It is the ability of two or more devices, including software, from the same manufacturer or different manufacturers, to:

Exchange information and use the information that has been exchanged for the correct execution of a specified function without changing the content of the data, and/or (b) communicate with each other, and/or (c) work together as intended.

Legacy Products

The MDCG has proposed to store legacy devices in EUDAMED without UDI-DI. (Status April 2019)

Update April 2021: Legacy devices do not need to have a UDI-DI, to maintain the EUDAMED usual data structure, they will be assigned a EUDAMED DI and a EUDAMED ID instead.

Legal Acts

The MDR provides for 11 delegated acts and 32 implementing acts. The definition of acts makes the MDR applicable.


EU directive, deadline: Dec 31, 2027/2028, replaces two old directives:

  • Directive 93/42/EEC on medical devices (Medical Device Directive, MDD)
  • Directive 90/385/EEC concerning Active Implantable Medical Devices (AIMD)

Procedure Pack

This defines a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose.

Product Labeling Obligation

The deadline differs for medical devices of different classes, but all data must be stored from May 2020.

Update April 2021: The dates for data maintenance in EUDAMED depend on the availability of the individual modules. Updated transition periods

  • Class III and implants: December 2027
  • Classes IIa and IIb: December 2028
  • Class I: December 2028

Production Identifier (PI)

The second of the two components of the UDI. It equals the GTIN and it is variable. It is the manufacturing ID and therefore contains the manufacturing and expiration date and the serial number.

Quality Management System

The complex requirements of the MDR can only be fulfilled by innovations in the quality management of the manufacturers. Our whitepaper about UDI compliance gives a good overview.

Single Point of Truth

Data in large volumes must be kept up-to-date and in compliance with guidelines for up to 20 years. So that nothing can get mixed up, there must be only one place where the data can be managed centrally and where all parties involved need to have access. Otherwise, there is a danger that not all versions are up to the same standard.


It entails a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose.

Storage Time

The data must be kept available for up to 20 years, but at least for the duration of the life cycle of the respective product.


Unique Device Identifiers label medical devices and make them traceable and clearly identifiable. Recalling actions is also made easier and counterfeits are identified more quickly.

UDI Carrier

The UDI carrier is 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.


It’s the UDI database with static data. See EUDAMED

Unit of Use DI

The Unit of Use DI serves to associate the use of a device with a patient in instances in which a UDI is not labeled 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.


Data format in which the data is exchanged with EUDAMED. The database also allows data to be uploaded as a “bulk upload”, i.e., multiple data in one step. XML uploads to EUDAMED can be done manually or automatically.

More MedTech News