The critical date is February 2, 2026. This is when the new QMSR fully replaces the old Quality System Regulation. ​ As of this date, manufacturers must adhere to the principles of ISO 13485:2016. While this is a manufacturer deadline, it empowers your hospital. ​ If their documentation is non-compliant, you have the regulatory backing to reject or suspend the use of that device at your facility.​

ISO 13485 requires meticulous documentation for reprocessing. If an IFU is missing steps for cleaning, rinsing, inspection, or sterilization—or if the instructions are contradictory or vague—the device is non-compliant and puts your SDP department at a high risk. ​ This alignment gives the SPD the leverage it needs to demand complete, validated IFUs from the manufacturer.​

 It is both. UDI/GUDID integrity is the core compliance mechanism for traceability under the new QMSR. Operationally, poor UDI data (device or product information) means you cannot accurately link a device to its correct, current IFU, patient record, or post-market surveillance data. ​

• A primary readiness step is performing a UDI Data Readiness Assessment to ensure your EHR, Inventory, and Supply Chain systems can accurately capture and utilize the full UDI. ​

• If you are struggling to capture this data effectively within your systems, Xcelrate UDI can help UDI data capture and with fixing missing and incorrect UDI data on your facility's behalf. ​

Under ISO 13485 and QMSR principles, verbal-only guidance that contradicts a validated document is unacceptable and non-compliant. The manufacturer is responsible for providing a validated, controlled IFU with a revision date. ​

• Your policy should be to reject verbal guidance and escalate the documentation gap immediately, as the device may not be safe or compliant to use. Only follow the manufacturer's controlled, printed documentation.​

• We recognize this can be challenging to manage for most hospitals, and so Xcelrate UDI takes on this responsibility on behalf of our clients a standard part of our regular service so hospital staff can focus their time and resources on providing quality care. ​

Start with an internal assessment of your device documentation processes. Use the Hospital Operational Readiness & Value Analysis Checklist we provided today to review your five most frequently reprocessed or implanted devices. Specifically, check the IFU against the required fields: validated cleaning, inspection, sterilization cycle, and post-sterilization drying time. This gap analysis will highlight your most urgent manufacturer accountability issues.​

Xcelrate UDI is always available to our clients who need assistance reviewing IFUs, GUDID entries, documentation gaps, or contract language around documentation and shelf life.​

• We work on our client’s behalf to address these compliance issues with manufacturers, freeing up your team’s valuable resources to focus on providing quality care.

• Contact us today if you need support!