Regulatory Entry Budget planner
Pick your product category and stage, tick what applies, and get an indicative one-off and yearly budget range.
Plan my budget →Regulation as a startup investment decision
Know your EU regulatory cost, timeline and go/no-go — before you invest.
Get an expert-reviewed view of your likely route, budget range, timeline and critical risks before you commit capital.
No card required. Every Snapshot is expert-reviewed before release.
Free tools · no account needed
Estimate your EU launch budget and timeline first
Two free planners built on the same cost and timing model as the Gate Snapshot. Answer a few questions and see a range in under two minutes.
EU launch timeline estimator
Get a low/high launch window and see which steps on the route from prototype to first EU sale drive the wait.
Estimate my timeline →Built for founders shipping a physical product into the EU
If any of this sounds familiar, Gate exists for you.
Physical or regulated product
Hardware, cosmetics, low-risk electronics, borderline medtech — not software.
Entering the EU from outside
Or launching a regulated product in the EU for the first time.
No settled regulatory route
You don't yet know which framework applies, or you're not confident it's the right one.
Clarity before the spend
You'd rather pay for investment clarity now than find out the hard way after tooling up.
How it works
A standardized methodology, run by regulatory experts — not an unsupervised algorithm.
1
Tell us about your product
A founder-first intake — plain language first, regulatory mapping happens on our side.
2
Get a free snapshot
Five headline numbers and one critical flag, drafted with AI and released by a regulatory expert — plus a package and price recommendation.
3
Pay and freeze scope
Your assessment is scoped to a specific product version and set of assumptions.
4
Expert review
Every paid report is issued only after a regulatory expert has reviewed it.
5
Get your Gate Report
Delivered within 5 business days of payment and complete input.
Packages
Start free. Upgrade when you need the number that actually drives a decision. Prices exclude VAT.
Ranges, not flat quotes: a single number for a product that isn't classified yet is a guess dressed up as precision. If your case needs Low-confidence or Quote-required treatment, we say so before you pay — not after.
Gate Snapshot
Free
See whether Decision is worth paying for, before you pay for anything.
- 5 headline numbers
- 1 critical flag, if any
- No detailed explanation
- AI-drafted, expert-released
Most popular
Gate Decision
€490
Fastest reports land in 3 business days — every report within 5.
- Regulatory classification
- Applicable requirements
- Full Regulatory Entry Budget
- Time-to-market timeline
- Regulatory risks
- Expert review call
Gate Strategy
€990–1,490
For when the range itself isn't the answer — see what changing the product could save.
- Everything in Gate Decision
- Alternative regulatory design scenarios
- Potential savings, if supported by REB
Typical Regulatory Entry Budget by category
Rough orientation before you request a Snapshot — not a quote. Every real case still gets its own priced, expert-reviewed REB with sourced, dated line items. Full tables by product maturity, time to market and unpriced triggers: EU Regulatory Entry Cost Index 2026.
Indicative
Consumer products
€4k–12k one-off
€0.8k–2k / year
Clear intended use, GPSR route — testing, technical documentation, EU Representative.
Indicative
Cosmetics
€3k–9k one-off
€0.6k–1.8k / year
With an existing safety dossier — CPNP notification, Responsible Person, claims review.
Indicative
Low-risk electronics
€7k–18k one-off
€1k–2.5k / year
LVD/EMC route, not radio or medical — testing, technical file, EU Representative.
See what you get
One worked example, one fictional product, all three tiers — so the price isn't the first time you see what it buys. Decisions and numbers first; legal detail comes after, not before.
Illustrative sample · fictional productAuraSense Glow Patch
A Bluetooth-connected LED light-therapy skin patch with a companion app.
VerdictProceedHigh complexity
- Regulatory Entry Budget
- €7,400–13,600 one-off
- + €1,200–1,800 per year
- Time to market
- 30–55 days
- Classification confidence
- Expert determination required
- Critical issues
- 1
Provisional — pending a formal MDR classification determination.
Regulatory route — assessed against 5 EU frameworks
Radio Equipment Directive 2014/53/EU (RED)
Any intentional radio transmitter brings the product under RED regardless of function.
Primary routeHigh confidence
Radio Equipment Directive (RED) · Cyber Resilience Act (CRA) · Medical Devices Regulation (MDR) · General Product Safety Regulation (GPSR) · EU AI Act — assessed and excluded
Requirements
Bluetooth radio module must pass RF, EMC and electrical-safety testing and be documented in a Technical Construction File.
High impactDirective 2014/53/EU (RED), Art. 3
Cybersecurity risk assessment and technical documentation covering the device, app and cloud data flow.
High impactRegulation (EU) 2024/2847 (CRA), Art. 13
+ 3 more requirements — unlocked in your report.
Regulatory risks
Medical-type claim risks reclassification into MDR Class IIa
CriticalIf confirmed, requires Notified Body conformity assessment: adds cost, adds 3–6 months, and needs a technical file to MDR Annex II/III standard.
+ 2 more risks tracked in your report.
See the complete Gate Decision format
Download sample Gate Decision reportFictional product. PDF. No registration required.
Reviewed by real experts, not just a model
Expert review on every report
AI drafts speed up the work — a regulatory expert releases your free Snapshot, and every paid report is issued only after expert review.
Independent, not a pitch
We don't use your report to sell you the fix. Downstream services are offered separately and transparently, never baked into the verdict.
What happens after Gate
Regulatory Gate gives you the decision first. If you proceed, sourcing and compliance support stay separate so they never shape the verdict.
1. Decide with Regulatory Gate
Should I enter the EU, and how much will it cost?
2. Source the right support
Find the laboratories, representatives and specialists your chosen route requires.
3. Execute compliance
Work with your chosen provider to meet the requirements — as a separate engagement.
FAQ
Is a Gate Report a legal opinion?
No. It's an indicative, expert-reviewed assessment — ranges and confidence levels, not a substitute for formal classification or legal advice.
How is the Regulatory Entry Budget calculated?
As an honest range, not false precision. Only mandatory, priced line items count toward the total; anything unpriced is always shown separately, never hidden.
What if my product doesn't fit your first-stage categories?
Some categories — borderline medtech, chemical mixtures, children's products, high-risk devices — need a separate evaluation before we can commit to a standard timeline. We'll tell you during eligibility review, before you pay. Every paid tier gets the same full assessment; Gate Strategy adds alternative regulatory design scenarios and potential savings on top.
Who prepares the free Gate Snapshot?
An AI model drafts the five numbers and the critical flag from your intake answers; a regulatory expert reviews, corrects and releases it before you see it. It gives indicative ranges, not a quote or a legal opinion. We send the AI only your product answers — never your budget figures, contact details or uploaded documents.
What if my product contains AI, a radio, connected software, or makes health claims?
We ask about it up front. Depending on your answers, we screen the product against the EU AI Act, the Radio Equipment Directive, the Cyber Resilience Act, the Medical Devices Regulation and the General Product Safety Regulation as part of the assessment. Anything that may fall into a stricter category — for example high-risk AI, a medical device, or a product for children — goes to a regulatory expert for determination, and it is reflected in your route, requirements and budget.
Can Regulatory Design actually change my regulatory outcome?
Only if the change is real. We only propose alternatives where the changed product, intended purpose, and claims are genuinely consistent — never advice on formally working around a regulation that still applies.
Know before you spend.
Start with a free Gate Snapshot — five numbers, one critical flag, no commitment.