Unique Device Identification – An overview of the UDI System in the EU
The European Medical Devices Regulation or EU MDR, as Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 is called brings many changes. One of them is the introduction of a device traceability system based on Unique Device Identification or in short UDI.
The UDI System as per EU MDR
The Unique Device Identification or UDI system is detailed in Part C of Annex VI of the EU Medical Devices Regulation (MDR). Unique Device Identification allows for the unambiguous identification of a specific device on the market. UDI on device level is comprised of the so-called UDI-DI (Device Identifier) and the UDI-PI (Production Identifier). In addition, a “Basic UDI-DI” designates the model of the medical device. As opposed to unique product identifiers, i.e. as per EU Falsified Medicines Directive FMD, the word ‘Unique’ in MDR terms does not necessarily imply serialization of individual production units or individual medical device entities.
The Basic UDI-DI: Identification of a Medical Device model
As per EU MDR, the Basic UDI-DI is the primary identifier of a medical device model and the main key to link information in the EUDAMED database and relevant documentation (e.g. certificates, declaration of conformity, technical documentation and summary of safety and clinical performance) with the device model. It also connects medical devices with same intended purpose, risk class and essential design and manufacturing characteristics. A Basic UDI-DI identifies a group or “family” of medical devices that all bear the same core characteristics, i.e. intended purpose, risk class, essential design. It consists of a series of numeric or alphanumeric characters. The Basic UDI-DI is not generated by the manufacturer but created through a globally accepted device identification and coding standard and delivered by an accredited issuing agency.
The Basic UDI-DI is independent from the packaging/labelling of the device and does not appear on any trade item or its label.
The UDI-DI: Identification of a product within a product group
The UDI-DI is a unique numeric or alphanumeric code that identifies a specific medical device within the product ‘family’. As per Annex VI of the EU MDR, a new UDI-DI required in case of a change of name/trade name, version/model, use, sterilization requirements, change of quantity in packaging, new indications/warnings.
Higher UDI-DIs are linked to the “Basic UDI-DI”; for example, single pack and six pack would have a different UDI-DI but the same “Basic UDI-DI”, same devices but in different language packaging would each have their own UDI-DI, etc.
The UDI-PI: Batch Identification
The UDI-PI is the production identifier: a numeric or alphanumeric code that identifies the unit of device production or batch. The different types of UDI-PIs include serial numbers (mandatory for active implantable devices), lot number, software identification, manufacturing or expiry date or both types of date. It is up to the manufacturer to define which type of UDI-PI is used. For active implantable devices, serial numbers on unit level are obligatory.
UDI issuing agencies
Basic UDI-DIs and UDI-DIs are not generated by manufacturers but issued by European Commission (EC) accredited issuing agencies. Manufacturers are free to choose any one of them but need to report which agency they got their Basic UDI-DI and UDI-DI from in the UDI database. On June 6, 2019, the European Commission designated the following organizations as UDI issuing agencies:
The UDI Carrier
As per EU MDR, the UDI carrier has to be placed on the label or packaging of the medical device and on all higher levels of packaging (except shipping containers). This is not equivalent to aggregation as there is no requirement to indicate parent-child relationship information on higher packaging labels. Reusable devices need a UDI carrier on the device itself and the UDI for implants must be identifiable prior to implantation. This needs to be taken into account when choosing the UDI carrier. Manufacturers are free to use linear bar code (concatenated or non-concatenated), data matrix or RFID technology for the machine-readable format. However, if RFID technology is used, an additional bar code (linear or 2D) needs to be printed as well.
UDI – Prepare now!
If you manage a lot of different medical devices categories and device models that are regularly revised and therefore require new UDIs or an update in the EUDAMED database, you should think about an M2M solution to connect to the EUDAMED UDI Database. An M2M (Machine to Machine) connection will enable automatic updates, saving you time, hassle and resources. And you need to choose a vendor very soon! From May 2020, you should be ready to test your connection and solution to be prepared to react quickly in case of a serious incident. Indeed, you can only file required incident reports and corrective action reports after successful registration and upload of UDI information into EUDAMED. From November 2021, UDI registration in EUDAMED will be mandatory for all devices.