EU MDR UDI Overview-Part I

Key Concepts & Compliance Basics for Manufacturers

Summary: Part I – Navigating EU MDR and IVDR compliance can be complex, especially when it comes to Unique Device Identification (UDI). Whether you’re a manufacturer, distributor, or regulatory affairs professional, understanding UDI-DI and UDI-PI is essential. In the first of a three-part series, we’ll break down what these identifiers mean, why they matter and how they fit into European medical device regulations.

Understanding EU MDR UDI: A Guide to Unique Device Identification in the European Union

Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices have introduced a robust system for device identification known as the Unique Device Identifier (UDI). This system enhances the traceability of medical devices across the European Union, supporting better patient safety and regulatory oversight.

To comply with these regulations, manufacturers are required to submit UDI and device-related information into EUDAMED, the European database for medical devices. While submission is currently voluntary, it is expected to become mandatory once the transition periods outlined in Regulation (EU) 2024/1860 conclude. Until then, additional national registration requirements may still apply.

What Is EU MDR UDI?

The EU MDR UDI system assigns a unique code to each medical device, ensuring clear identification and traceability throughout its lifecycle. This code is composed of two key elements:

1. UDI-DI (Device Identifier) – This component is specific to each device and links to essential regulatory and product information. It is associated with one Basic UDI-DI and helps distinguish devices based on their design and intended use.
2. UDI-PI (Production Identifier) – This part identifies production details such as the lot number, serial number, and expiration date. For certain device types, like active implantables, the serial number is mandatory. Configurable devices must also have a unique UDI-PI assigned individually.

It’s important to note that while UDI-PI data is critical for traceability, it is not stored in the public UDI database. Instead, manufacturers define and manage these identifiers internally.

Benefits of the UDI system:

• Improved traceability of devices across the supply chain
• Streamlined recall processes in case of safety issues
• Enhanced protection against counterfeit products
• Greater patient safety through accurate device tracking

Importantly, the UDI system complements existing labeling requirements—it does not replace them.

Phased Implementation of EU MDR UDI

The EU has rolled out the UDI system in phases, prioritizing high-risk devices first, followed by medium- and low-risk devices. This mirrors strategies in other regions, like the U.S., ensuring a smooth transition for manufacturers and regulators.

Manufacturers must register:

• Medical Devices, including systems and procedure packs under Regulation (EU) 2017/745
• In Vitro Diagnostic Devices, including kits, as defined under Regulation (EU) 2017/746

Read Part 2 our EU MDR UDI Series: EU MDR UDI Identifiers and Structure Explained

Read Part 3 of our EU MDR UDI Series: EU MDR UDI Implementation

Additional Resources:

1. European Commission – Unique Device  Identification (UDI) System  under the EU medical devices Regulations 2017/745 and 2017/746 – https://health.ec.europa.eu/document/download/add107c5-0ca8-45d3-b049-63bb84c4ce31_en?filename=md_faq_udi_en.pdf
2. Public Health – Unique Device Identifier – UDI – European Commission – https://health.ec.europa.eu/medical-devices-topics-interest/unique-device-identifier-udi_en
3. BSI – Overview of the EU Basic UDI-DI  – https://compliancenavigator.bsigroup.com/en/medicaldeviceblog/overview-of-the-eu-basic-udi-di/
4. European Commission – Identifiers – https://webgate.ec.europa.eu/udi-helpdesk/en/udi-assignment/identifiers.html
5. European Commission – MDCG 2018-6 Clarifications of UDI related responsibilities in relation to Article 16 of the Medical Device Regulation 2017/745 and the In-Vitro Diagnostic Medical Devices Regulation 2017/746 https://ec.europa.eu/docsroom/documents/31927
6. Public Health – UDI/Device registration – European Commission – https://health.ec.europa.eu/medical-devices-eudamed/udidevice-registration_en
7. VDE Health – UDI for medical devices according to MDR – https://www.vde.com/topics-en/health/consulting/udi-for-medical-devices-according-mdr
8. ISPE -Medical Device UDI Components Management in the European Union – https://ispe.org/pharmaceutical-engineering/july-august-2021/medical-device-udi-components-management-european-union
9. TUV Article 27 (MDR): Unique Device Identification system – https://de-mdr-ivdr.tuvsud.com/Article-27-Unique-Device-Identification-system.html
10. MAVEN – Unique Device Identification (UDI) Requirements in EU MDR – https://mavenprofserv.com/blog/udi-requirements-new-requirement-in-eu-mdr/
11. Johner Institute – Unique Device Identification (UDI) in the EU – https://blog.johner-institute.com/regulatory-affairs/unique-device-identification-udi/
12. DDismart – UDI & EUDAMED Explained under EU MDR – https://www.ddismart.com/blog/udi-eudamed-explained-under-eu-mdr