Methodology
Regulatory Gate produces a decision, not just a document. This page explains, concretely, how that decision is reached — what the AI is allowed to draft, what a human always checks, when a second reviewer is brought in, and where the line sits between an indicative assessment and formal advice.
The review pipeline
- Intake. You answer structured questions about the product, its intended use, target markets and evidence you already have — the same questions whether you take the free Gate Snapshot or a paid Gate Decision/Strategy report.
- Regulatory screening. Your answers are screened against the frameworks that most often apply to a physical or connected product entering the EU: the General Product Safety Regulation, applicable CE-marking legislation, the Radio Equipment Directive, the Cyber Resilience Act, the Medical Devices Regulation, and the EU AI Act where relevant.
- AI-assisted drafting. An AI model drafts a first pass — the headline numbers for a free Snapshot, or a starting classification, requirement list and cost breakdown for a paid report. It only ever sees the product-related fields listed in the Privacy Policy — never your budget figures, contact details or uploaded documents.
- Expert review. Every draft — free or paid — is checked, corrected where needed, and released by a human regulatory expert before you see it. Nothing is released automatically. This is a technical constraint of the system, not just a promise: there is no path in the product that shows you an AI draft the expert step hasn't signed off.
- Senior review for the harder cases. Product categories that are more likely to be borderline or high-consequence — for example medical devices near the classification boundary, chemical mixtures, children's products, or any route the first reviewer flags as low-confidence — get a second, senior review before the report is issued.
Human sign-off
No decision with a legal or similarly significant effect on you is made by the AI alone. A human expert reviews, can correct, and decides what is actually released — the same standard stated in the Privacy Policy and enforced by the product itself, not just a policy on paper.
A Gate report is an indicative, expert-reviewed assessment — ranges and confidence levels, not a substitute for formal regulatory classification or legal advice. Where a route genuinely can't be determined with confidence from what you've told us, the report says so rather than guessing.
Independence
The assessment is not used to sell you a fix. If your product needs testing, certification, an EU Authorised Representative or similar downstream services, those are offered separately and transparently — never baked into the verdict, and never a reason to shade a classification one way or the other.
Conflicts of interest. A reviewer who has a personal or financial interest in a specific outcome for a case does not review that case. This standard applies to every report we issue.
Who reviews your assessment
Every Snapshot and report passes through a regulatory expert before release, and complex or low-confidence cases get a second, senior review, as described above. Individual reviewer profiles — names, qualifications and scope of expertise — are being finalized and will be published on this page.