March 2026 is one of those moments where regulatory "updates" translate into real operational changes. In the US, FDA inspections have shifted under QMSR. FDA also updated two major digital health guidances that change where the line sits between "device" and "non-device" software. In the EU, EUDAMED mandatory use is no longer hypothetical. In Canada, Health Canada's updated MDL application management guidance is now in force.

Below are the changes that matter, and what a practical QA/RA team should do next.

1) FDA QMSR: inspections are now risk-based under CP 7382.850

As of February 2, 2026, FDA stopped using QSIT and began inspecting using the process described in CP 7382.850. FDA also states it is no longer using older inspection program documents (including CP 7382.845 and CP 7383.001) after February 2, 2026.

What to do now

  • Update your internal inspection readiness playbook to align to CP 7382.850 (do not assume a QSIT-style inspection flow).
  • Train leadership on what the new inspection model means for how you tell your quality story during an inspection.

Time-sensitive event: FDA is hosting a Town Hall on April 1, 2026 specifically on QMSR risk-based inspections, and questions must be submitted by March 16, 2026.

2) FDA updated CDS guidance, and the town hall is March 11, 2026

FDA's Clinical Decision Support Software final guidance was re-issued January 29, 2026, and FDA is holding a town hall March 11, 2026 to discuss it.

This is a high-impact update for SaMD teams because FDA is clarifying which CDS functions may be excluded from the device definition and how existing digital health policies still apply for software that remains a device.

What to do now

  • Re-check intended use statements and user assumptions (HCP vs patient) against the updated CDS framing.
  • Align product language, UI, and labeling claims before your next submission or marketing update.

3) FDA updated General Wellness policy (January 2026)

FDA issued a revised final General Wellness: Policy for Low Risk Devices guidance on January 6, 2026, superseding the 2019 version.

This matters if you build consumer-facing sensors, apps, or wellness features and want to stay out of device regulation. It is also relevant if you sell a regulated device but have companion features that you market as wellness.

What to do now

  • Audit your claims. Most regulatory surprises here come from marketing and implied clinical use, not engineering.

4) FDA final RWE guidance (December 2025): bigger expectations, clearer playbook

FDA finalized Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices in December 2025. FDA also publicly highlighted that it will accept certain RWE without always requiring identifiable individual patient data to be submitted in a marketing submission.

What to do now

  • If you plan to use registries, EHRs, claims, device-generated data, or pragmatic data, align your evidence plan to the final guidance now, not at submission time.

5) EU: EUDAMED mandatory use begins May 28, 2026 for 4 modules

The European Commission confirmed that as of May 28, 2026, the first four EUDAMED modules become mandatory: Actor registration, UDI/Devices, Notified Bodies and Certificates, and Market Surveillance.

This follows the EU's gradual roll-out framework for EUDAMED.

What to do now

  • If you have EU activity, assign ownership for EUDAMED data governance now. Waiting until May is how teams miss the date.

6) Canada: MDL application management guidance is now effective, and IMDRF ToC is adopted

Health Canada's updated guidance on managing MDL applications is effective February 2, 2026. Health Canada also published guidance adopting the IMDRF Table of Contents format for medical device applications.

What to do now

  • If Canada is in scope, standardize your submission build to the IMDRF ToC structure to reduce avoidable screening issues and rework cycles.