Learn About the Significant Differences Between U.S. and EU UDI Requirements and How Compliant Devices Meet SFDA Requirements
Executive takeaways
- Three systems, one harmonized foundation: The U.S., EU, and SFDA Unique Device Identification (UDI) systems all follow GHTF/IMDRF guidance, so they are very similar in structure — but the details differ in ways that affect implementation.
- SFDA aligns closely with EU MDR: Saudi Arabia's MDS-G34 guidance adopts EU Medical Device Regulation (EU MDR) approaches for implantable devices, configurable devices, and convenience kits/procedure packs.
- SAUDI-DI database is central: The UDI device identifiers (UDI-DIs) of all devices within kits and packs — whether physically marked or not — must be entered into the SAUDI-DI.
- A U.S./EU-compliant device is not automatically SFDA-compliant: Manufacturers must understand where the three regulatory domains overlap and where they diverge before expanding into the Saudi market.
In our recent webinar on complying with the Saudi Food and Drug Authority (SFDA) UDI requirements, we received a lot of questions about the differences between SFDA’s MDS-G34 version number 3.0 (dated September 6, 2020) “Guidance on Requirements for Unique Device Identification (UDI) for Medical Devices” and the existing U.S. and EU UDI requirements. More specifically, manufacturers wanted to know what additional changes, if any, need to be made to allow a U.S./EU UDI compliant device to meet the SFDA requirements. To help with this, I have summarized the major differences. It is important to note that there are significant differences between the U.S. and EU UDI requirements; therefore, a manufacturer must understand where these three systems overlap, and the differences that may affect UDI implementation in one of these regulatory domains.
In general, following the Global Harmonization Task Force/International Medical Device Regulators Forum (GHTF/IMDRF) guidance, the U.S., EU, and SFDA UDI systems are very similar. Here are the highlights of the significant differences, particularly between the U.S. and SFDA requirements:
- Class I devices require a full UDI [device identifier (DI) and production identifier (PI) in automatic identification and data capture (AIDC) and human readable interpretation (HRI)].
- If only linear barcodes are used, they must be concatenated into a single barcode.
- All barcodes must be verified (always a requirement; SFDA makes this explicit).
- The HRI must be the full HRI only, not a mix of HRI and non-HRI (also always a requirement; made explicit).
- The UDI must be readable during normal use and throughout the intended life, and its AIDC must accessible during normal operation, storage and transport.
- In addition to the usual change rules, a new DI is also required when a change could lead to ambiguity in the identification of the device or affect the traceability of the device.
- For devices sold at retail, higher levels of packaging—not intended for retail point of sale—must contain a full UDI.
- Each component that can be removed or separated, or is available and distributed on its own, must have its own UDI and meet all of the other UDI requirements.
Implantable Devices
For implantable devices, the MDS-G34 guidance follows the European Union Medical Device Regulation (EU MDR) requirements:
- All active implantable devices must be controlled by serial number.
- The full UDI of an implantable device must be readily available, either electronically or readable (scannable), at the point of implantation.
- Implantable devices must include an “implant card” with information allowing the identification of the device, including its UDI (except for sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips and connectors).
Configurable Devices
Also, in keeping with the EU MDR requirements, MDS-G34 guidance introduces requirements for configurable devices, albeit with a twist:
- A “configurable device UDI” (CD-UDI) must be assigned to the entire configurable device.
- The CD-UDI must be placed on the assembly that will not be exchanged during its lifetime.
- Alternatively, the CD-UDI can be presented electronically (e.g., through a computer interface), and NOT on the device (if electronic, provide information in the SAUDI-DI on how it is accessed).
A device that is fully compliant with U.S. and EU UDI requirements is not automatically compliant with SFDA. The systems share a harmonized foundation, but the differences are exactly where implementation risk lives.
Convenience Kits and Procedure Packs
The last major difference is related to convenience kits/procedure packs. Unlike in the United States, all of the devices within the kit/pack must have their own UDI, unless the device is:
- An individual single-use disposable device, which cannot be used outside the context of the kit or procedure pack, or
- Otherwise exempt from having a UDI on the label or package of the device that is in the kit or procedure pack.
More importantly, the SAUDI-DI requires that the UDI-DIs of all devices within the kits/packs, whether marked or not, be entered into the SAUDI-DI.
How to assess a U.S./EU device against SFDA requirements
- Map the overlap: confirm which UDI elements (DI, PI, AIDC, HRI) already satisfy all three systems so you do not rework what already complies.
- Close the SFDA-explicit gaps: verify barcodes, enforce full-HRI-only labeling, and concatenate linear barcodes where required — items SFDA makes explicit even when they were always expected.
- Apply the EU MDR-aligned rules: address implantable device serialization and implant cards, configurable device (CD-UDI) placement, and per-device UDIs within kits and packs.
- Reconcile to the SAUDI-DI: ensure every UDI-DI, including unmarked devices inside kits, is correctly entered into the SAUDI-DI database with accurate, traceable data.
- Sustain compliance as rules change: build change control so a new DI is issued whenever a change could create ambiguity or affect traceability — across every market you serve.
Because UDI labeling generates regulated electronic records and is submitted to regulator-controlled databases, the same record-integrity and traceability disciplines that govern 21 CFR Part 11 compliance apply to your UDI program. Managing those obligations as configurations, suppliers, and guidance evolve is a core part of validation lifecycle management, and keeping submissions accurate over time benefits from a Cloud Assurance approach to continuous compliance.
UDI compliance also extends across your supply base. When components, contract manufacturers, and packaging partners contribute to a finished device, disciplined third-party risk management helps ensure every party in the chain meets the identification and traceability requirements that SFDA, the FDA, and EU MDR demand.
USDM Life Sciences continues to research issues related to the submission of data to the SAUDI-DI. We will provide additional information when it is available.
FAQ: SFDA, U.S., and EU UDI Requirements
Is a device that complies with U.S. and EU UDI requirements automatically compliant with SFDA?
No. The three systems share a harmonized foundation under GHTF/IMDRF guidance and are very similar in structure, but SFDA's MDS-G34 guidance introduces differences — and aligns with EU MDR in several areas — that mean a U.S./EU-compliant device may still need changes to meet SFDA requirements.
What does SFDA require for implantable devices?
Following EU MDR, MDS-G34 requires that all active implantable devices be controlled by serial number, that the full UDI be readily available (electronically or scannable) at the point of implantation, and that implantable devices include an implant card identifying the device and its UDI — with specific exceptions such as sutures, staples, dental fillings, screws, wires, and pins.
How do SFDA requirements for convenience kits and procedure packs differ from the U.S.?
Unlike in the United States, every device within a kit or procedure pack must have its own UDI unless it is an individual single-use disposable that cannot be used outside the kit, or is otherwise exempt. In all cases, the UDI-DIs of all devices in the kit or pack — whether physically marked or not — must be entered into the SAUDI-DI.
What is a configurable device UDI (CD-UDI) under SFDA?
In keeping with EU MDR, a CD-UDI must be assigned to the entire configurable device and placed on the assembly that will not be exchanged during its lifetime. Alternatively, it can be presented electronically rather than on the device, in which case the SAUDI-DI must explain how the CD-UDI is accessed.
When does SFDA require a new device identifier (DI)?
In addition to the usual change rules, a new DI is required whenever a change could lead to ambiguity in the identification of the device or affect the traceability of the device.