Learn about the significant differences between U.S. and EU UDI requirements and how these compliant devices meet SFDA requirements.
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” (https://sfda.gov.sa/sites/default/files/2020-09/MDS-G34e.pdf) 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.
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).
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).
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.
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.
Contact USDM to discuss your UDI needs.