UDI and EUDAMED to facilitate the monitoring and traceability of medical devices

To improve and facilitate the monitoring and traceability of medical devices, Regulation (EU) 2017/745 on medical devices (MDs) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDs) have made the unique identification system mandatory for all medical devices. The main objective of this identification system for MDs is to ensure patient safety as it aims to secure the entire legal MD supply chain. It is based on two main components: the UDI system and a European database called EUDAMED.

What is the UDI system?

The two new regulations – Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – define the Unique Device Identifier (UDI) in Article 2(15) as: “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”.

The UDI takes the form of a barcode or a data matrix code; it contains information relating to the device. The UDI comprises two identifiers:

• a “device” identifier (UDI-DI): specific to a manufacturer and a device, it provides access to the information laid down in Part B of Annex VI (name and address of the manufacturer, medical device nomenclature code, risk class of the device, etc.)
• a “production” identifier (UDI-PI): identifies the unit of device production as specified in Part C of Annex VI (the different types of UDI-PIs include serial number, lot number, software identification and manufacturing or expiry date or both types of dates).

The UDI system directly impacts the obligations of all economic operators in the supply chain of the medical device. Indeed, manufacturers are now responsible for assigning an identifier to their device and affixing the UDI to the device itself and to its packaging. Higher levels of packaging have their own UDI (unique UDI-DI). The UDI carrier must be readable during normal use and throughout the intended lifetime of the device (whether or not the MD is reusable). In addition, the manufacturer must transfer device data elements to the UDI database. These obligations must be verified by importers and distributors. As stated in Articles 27 and 29 of the MDR, the UDI system applies to all medical devices except custom-made devices.

Note that for reusable MDs (those that need to be cleaned, disinfected, sterilised or reconditioned between uses), the requirement to affix the UDI directly to the device may not be met if direct marking compromises the safety or performance of the device or if it cannot be done for technical reasons.

The UDI system will ensure the traceability of medical devices regardless of where they are manufactured and used. Thanks to a unique and unambiguous international code, each medical device will be identified throughout its life cycle. This identifier also facilitates product recalls and any other safety corrective actions.

What are the time frames for applying the UDI?

The affixing of UDIs to medical devices differs depending on the type of device (reusable or not) and the class of the device. This difference in time frames is due to the fact that the UDI is affixed to the packaging for non-reusable MDs whereas it is affixed directly to reusable MDs.  

What is the EUDAMED ?

The UDI device identification system is integrated into EUDAMED, the European database on medical devices. This European database is composed of six modules including one UDI module. EUDAMED therefore centralises all information concerning the medical devices present on the internal market. This information is provided by manufacturers who, in return, have access to all or part of the data stored by EUDAMED for consultation and use.

A new concept has also been introduced by the MDR: the Basic UDI-DI, which is used to group medical devices within an identified MD family. It is a group identifier that identifies the model of the device and allows medical device information to be entered into the EUDAMED database. The Basic UDI-DI should not be confused with the unique identifier affixed to the device or its packaging; this is why a future article will specifically address the Basic UDI-DI. 

On 30 October 2019, the European Commission announced the postponement of EUDAMED for a legal reason related to the interpretation of Article 34 on the functionality of EUDAMED. Thus, the implementation of all of the EUDAMED modules has been announced for 26 May 2022.

Note, however, that the UDI module will be ready by May 2021. Furthermore, the UDI assignment requirement does not change with the delayed implementation of EUDAMED!

Why should you turn to Efor for assistance?

Our Efor quality and regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics (non-exhaustive list):

• Support in setting up the UDIs of your devices, whatever the nature of your MDs
• Support in identifying UDI-DI and UDI-PI codes
• Support in affixing the UDI to the device and to all higher levels of packaging
• Support in transferring device information to the EUDAMED UDI database
• Support in setting up and qualifying your equipment and in validating the computerised systems required for the UDI 

Feel free to contact us using the contact form