Unique Device Identification (UDI) under EU MDR
Challenges and Implications for Class I Medical Devices
by Dr. Marvin Ferner, Head of Quality and PRRC
The Unique Device Identification (UDI) system, introduced under the EU Medical Device Regulation (MDR) 2017/745, aims to enhance traceability, safety, and post-market surveillance of medical devices. While the concept promises significant benefits for stakeholders, its implementation - especially for Class I (reusable) devices - poses substantial challenges for manufacturers, particularly those producing low-cost products.
Regulatory Framework and Deadlines
Under the MDR, manufacturers must assign UDIs to all devices (except custom-made ones) before placing them on the market. The UDI consists of:
- Basic UDI-DI: Identifies a group of devices with the same intended purpose.
- UDI-DI: Device identifier specific to a model/version.
- UDI-PI: Production identifier (e.g. lot number, expiry date).
Key Deadlines for Class I Devices [1, 2]:
- UDI carrier on labels: Required from 26 May 2025.
- Direct marking on reusable Class I devices: Required from 26 May 2027.
- Mandatory use of EUDAMED UDI/Device registration module: Expected from Q1 2026, six months after EUDAMED is declared fully functional [3].
For reusable products like dosing pipettes, the direct marking requirement by May 2027 is particularly relevant.
Packaging Requirements
The MDR outlines specific rules for placing the UDI carrier on packaging [4]:
- Individually packaged single-use Class I devices: UDI carrier not required on the individual packaging but must appear on higher-level packaging (e.g., cartons).
- Retail point-of-sale packaging: UDI-PI in AIDC format not required.
- Shipping containers: Exempt from UDI carrier requirements.
- Space constraints: If space is limited, the UDI carrier may be placed on the next higher packaging level.
- Home care devices: Human-readable interpretation (HRI) must appear even if space constraints prevent AIDC.
Each packaging level must have its own unique UDI unless exempted.
Co-packaged Medical Devices: Regulatory Challenges
Co-packaged products that combine a medical device - such as a Class I dosing aid - with a medicinal product present unique regulatory challenges under the EU MDR. While the device component may be low-risk and classified as Class I, it must still meet all applicable MDR requirements, including UDI assignment, technical documentation, and conformity assessment procedures [5]. This becomes particularly complex when the device is not marketed independently but is integrated into secondary packaging of a medicinal product. In such cases, manufacturers must determine whether the device is considered an 'integral' part of the medicinal product or a 'standalone' device, which affects whether the MDR or the medicinal product directive takes precedence [6, 7]. These borderline determinations can lead to uncertainty and this raises practical challenges: Should the UDI be placed on the device, the leaflet, the inner blister, or the outer medicinal carton? The MDR is silent on such specifics, leaving manufacturers to interpret labeling hierarchies and packaging levels on a case-by-case basis.
These regulatory ambiguities are not merely academic. They have tangible market consequences: the cost of compliance for low-margin, low-risk devices may become disproportionate, particularly when the device is only a minor component of a larger medicinal product. In some cases, manufacturers may opt to withdraw such devices from the EU market altogether, not due to safety concerns, but because of regulatory overreach and economic infeasibility.
Industry Challenges
1. Cost Burden for Low-Value Products
For manufacturers of low-cost Class I devices, the cost of UDI implementation - including barcode printing, packaging redesign, and database registration - can be disproportionately high. This is especially problematic for reusable devices requiring direct marking, which may involve laser engraving or specialized labeling technologies.
2. Complex Packaging Scenarios
Devices sold in sets, kits, multi-level packaging, or co-packed require careful UDI planning. Each component may need its own UDI, and packaging levels must be uniquely identified, increasing logistical complexity.
3. EUDAMED Delays
The gradual rollout of EUDAMED has created uncertainty. Although the UDI/Device registration module is expected to be mandatory by Q1 2026, manufacturers must prepare without full access to the system [3].
Global Harmonization and FDA Perspective
While the EU MDR sets its own UDI framework, the FDA has implemented a similar system under 21 CFR Part 830. Although harmonization efforts exist through the International Medical Device Regulators Forum (IMDRF), differences in timelines, data formats, and regulatory expectations remain.
FDA UDI Requirements and Exemptions for Reusable Class I Devices
The U.S. Food and Drug Administration (FDA) introduced its UDI system under 21 CFR Part 830, with the goal of improving device traceability and post-market surveillance. However, the FDA’s approach to Class I devices such as dosing pipettes - is notably more flexible than the EU MDR.
Key Points:
- Class I devices that are exempt from FDA’s Good Manufacturing Practice (GMP) requirements under 21 CFR 820.180 are also exempt from UDI labeling requirements.
- Many low-risk, reusable Class I products, including manual dosing pipettes, fall under this exemption if they are not intended for implantation, do not support or sustain life, and are not critical to health [8].
- The FDA maintains a list of exempt devices in its UDI Policy Guidance and product code database, where manufacturers can verify if their product qualifies.
If a medical device is classified as a Class I, 510(k)-exempt device and is not subject to GMP, it is not required to carry a UDI under FDA regulations. This exemption significantly reduces the regulatory burden for U.S. market access compared to the EU MDR, where even low-risk reusable devices must comply with UDI -including direct marking by May 2027.
Conclusion
Despite the challenges, UDI offers clear advantages:
- Manufacturers: Improved inventory control, recall management, and regulatory compliance.
- Healthcare Providers: Enhanced patient safety through accurate device identification.
- Patients: Better transparency and traceability of medical devices used in care.
Therefore, the UDI system under MDR is a transformative step toward safer, more transparent healthcare. Yet, for manufacturers of Class I devices, it introduces significant technical, logistical, and financial challenges. From complex packaging hierarchies to direct marking requirements and barcode verification, the path to compliance is far from trivial.
Do you need expert guidance on UDI implementation for your medical devices? The regulatory specialists at elmplastic have extensive experience navigating MDR compliance challenges, from technical implementation to cost-effective solutions for Class I devices. Whether you're dealing with complex packaging scenarios, direct marking requirements, or co-packaged products, our team at elmplastic can help you develop a tailored compliance strategy that meets regulatory demands while maintaining economic viability.
Contact elmplastic today to discuss your UDI implementation needs and ensure your medical devices meet all MDR requirements efficiently and effectively.For questions regarding implementation or support, the experts at elmplastic are always available to assist you. Visit our website at www.elmplastic.com to explore our full range of services and submit your UDI consultation request directly through our contact form.
References
[1] Deadlines - Europese Commissie
[2] Unique Device Identification (UDI) in the EU
[3] MDCG 2025-7 Position Paper Timelines MUDI-DI - Public Health
[4] Packaging levels - European Commission
[5] MDCG 2021-24 Guidance on classification of medical devices
[6] Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v3
