Overview of the EU Basic UDI-DI

On 5 May 2017, the new EU MDR 2017/745 and IVDR 2017/746 regulations (referred to in this blog as ‘the Regulations’) were published and formally introduced the UDI system in the EU. One of the components of a UDI system is the UDI itself, which allows for the unambiguous identification of a specific device on the market and is composed of the UDI-DI and UDI-PI.

The Regulations require the assignment of a Basic UDI-DI to medical devices. The concept of a Basic UDI-DI is new and currently unique to the EU. The purpose and use of the Basic UDI-DI is different from the use of the device UDI-DI (see Table 2)

Table 2: Key differences between Basic UDI-DIs and UDI-Dis

The Basic UDI-DI is an EU approach for linking devices to their regulatory documentation and it is intended to uniquely identify the product model throughout the entire life cycle of the product. The MDCG’s definition of it is:

The Basic UDI-DI is the main key in the database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) to connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/ separate from the packaging/labelling of the device and it does not appear on any trade item[1].

NOTE: Several different definitions of Basic UDI-DIs are found within various EU documents, including the Regulations.

This blog recommends that the MDCG’s definition is used.

The key functional aspects of the Basic UDI-DI are that it is:

• the primary identifier of a device model
  • it connects devices with the same intended purpose, risk class and essential design and manufacturing characteristics
• the main record key in the UDI database
  • it connects all associated UDI-DIs in the UDI database with the information in other EUDAMED modules
• the main key within (regulatory) documentation
  • in technical documentation
  • in SS(C)P
  • in EU DoCs
  • in notified body certificates as well as CFSs
  • in PSUR
  • in post-market clinical investigation or performance study application in regulatory forms (e.g. Manufacturer’s Incident Report)
• independent from labelling
  • separate from the packaging or labelling of the device and it does not appear on any trade item (it may appear on the instructions for use)[2]

Before placing a device (other than one that is custom-made), clinical investigational device (subject to the MDR)[3] or device for performance evaluation (subject to the IVDR)[4] on the market, the manufacturer has to assign – in accordance with the rules of the IE – a Basic UDI-DI to the device and input it into the UDI and Device Registration module of EUDAMED, together with the other core data elements related to that device.[5]

Manufacturers should establish processes for the assignment and maintenance of Basic UDI-DIs based on the above criteria. This is an imperative first step as device identifiers (once registered) cannot be moved between Basic UDI-DIs, and a change in the linkage would require enumeration of new UDI-DIs, which would have downstream impacts on, for example, labels, product certificates and customers.

Many regulatory documents necessitate the identification of the Basic UDI-DI (e.g. the SS(C)P, PSUR, DoC, certificates and CFS), so manufacturers have to consider the association requirements of these documents during the assignment of Basic UDI-DIs.

Manufacturers should also consider the use of searchable terms with device name or device model data attributes.

The EUDAMED UDI data dictionary defines all the data elements associated with the Basic UDI-DI, and identifies those that can be updateable[6].  Other useful documents for the identification of data attributes requiring the assignment and registration of a new Basic UDI-DI for devices subject to the MDR[7] and IVDR[8] are available. However, it should be noted that updates to these documents are needed to reflect the data dictionary.

Manufacturers should understand the EUDAMED data attributes for the Basic UDI-DI, and recognize that if some of the data attributes were changed, that would trigger the need to issue a new Basic UDI-DI. With a change in the Basic UDI-DI, all associated UDI-DIs would also need to change.

NOTE: One change that can cause this trigger of a new Basic UDI-DI is if a manufacturer’s EUDAMED SRN changes – e.g. if a manufacturer were to relocate to another country (meaning change(s) to the name and address on the label), that would require a different competent authority to issue a new SRN, with verification and validation of that manufacturer’s information required to be submitted into the Economic Operators (Actor) Registration module of EUDAMED.

This blog is an excerpt from our whitepaper on European Union Medical Device Regulation and In Vitro Device Regulation: unique device identification , please download the full whitepaper to find out more about the UDI System and the EU MDR 2017/745 and IVDR 2017/746 regulations.