REGULATION (EU) 2017/745 · ANNEX VIII
One questionnaire, six markets. It applies each jurisdiction's own rules and shows its work — which rule matched, what it produced, and why the others did not. Free, indicative, about five minutes.
Indicative only. Not a regulatory determination and not a conformity assessment. Under Article 10 of the Regulation, responsibility for classification rests with the manufacturer.
Intended purpose, invasiveness, duration of contact, whether it is active, and the special categories. Around five minutes.
Not just the obvious one. Where several rules apply, the strictest prevails — and the ones that were superseded are recorded too.
A report that reproduces the declared answers in full, names the rule that determined the class, and lists the points that still need a professional.
| IT DOES | IT DOES NOT |
|---|---|
| All 22 rules evaluated — 13 determined outright, 5 on a declared judgement, 2 reported as open, 2 with a branch not yet implemented | Settle the 2 rules whose outcome turns on an assessment rather than a fact — it reports those as open, and names the assessment that would close them |
| Show the reasoning behind the class, so it can be discussed and checked | Validate your intended purpose, or notice that your marketing contradicts it |
| Report the class in six markets at once — the EU, Great Britain, Australia, Switzerland, Canada and Brazil — and search the FDA catalogue for the United States | Tell you whether your product is a medical device at all |
| Produce a report a regulatory professional can attach to their own assessment | Replace that professional, or bind any Notified Body or authority |
A class earned in one jurisdiction says nothing definitive about another — and the markets that share Europe's class labels are the ones most likely to mislead.
Unlimited classifications, full reports, cross-market comparison, the FDA product code search. No card, and no limit while the beta lasts.
The classification logic has not yet been independently validated against Annex VIII and tested through documented classification scenarios by a regulatory affairs professional. Until it has, charging for it would mean selling something unverified — so we do not. The beta ends when that validation is complete and published, with the reviewer named and the validated version identified.
We would rather tell you that than let the free period look like generosity.
Ten reports a month free, then €99 per report. The classification itself — the class, every rule that applied, and the reasoning — stays free and unmetered, always. What is paid for is the document: the multi-page report with the regulatory citations, carrying your name, your qualification and your practice's mark.
We are publishing the number now, before building any of it, because if €99 is wrong we would rather hear so from you than discover it afterwards.
Reports you generate during the beta stay available in your account for as long as we offer the archive, within the retention period in the privacy policy, and you can download or regenerate them at no charge in that time. That benefit does not cover markets added later, a changed device, or paid features introduced after the beta — we would rather define it narrowly and keep it than promise broadly and qualify it afterwards.
Tell us what is wrong with the results and we will fix it. That is the whole point of the period, and the reason it is worth your time rather than only ours.
If you are a regulatory professional willing to do that in writing, the beta programme puts a number on it: five signed pieces of feedback, three years of free access once the beta ends.
