Venitara Preparation
Pathway Ready
Classification, intended purpose and regulatory roadmap, for devices and in vitro diagnostics
Your answers, read against the rule text and checked by a senior regulatory expert, settle how your product is regulated and what has to happen before it can be sold.
Where this sits
01Pathway
ReadyYou are here
02Market
Ready
03Company
Ready
04Evidence
Ready
05Submission
Ready
06Revenue
Ready
Your file, growing. Each stage begins with the work already in it.
Available at any stage
When to use Pathway Ready
You have built something that works, and now you need to know what it counts as in law. The class decides the route, the evidence, the cost, and the timeline, and every decision after it inherits that answer.
A classification set too low reaches its Notified Body with the wrong evidence behind it. Correcting that means rebuilding the evidence programme, not the document.
What you receive
The Regulatory Roadmap
The classification with the rule it comes from, the conformity route that follows, and the milestones between today and a submission.
What it contains
The classification rationale, with the Annex VIII rule cited
The applicable conformity assessment route
The intended purpose statement the rest of the technical file is built on
The milestones between now and submission
What the work covers
Each line is a question your product has to answer before anyone can sell it. What the answer settles for you comes first, and the regulatory basis sits underneath it, so you can check the reading yourself or hand it to someone who will.
| Document | What it settles |
|---|---|
| Qualification determination | Whether your product counts as a medical device in law at all. Every question after this one inherits the answer, and being told you sit outside the regulation is a result worth having in writing.MDR 2017/745, Article 2 |
| Intended purpose statement | What your product is for, who operates it, and on whom it is used, written precisely enough to build on. The rest of the technical file is assembled against this statement, and changing it later can change your class.MDR Annex II, Section 1 |
| Classification rationale | Your risk class, the numbered rule that produces it, and the reasoning set out in full. The class is the decision that sets how much evidence you have to fund and how long the route takes.MDR Annex VIII |
| Conformity assessment route | The approval route your class commits you to, including whether a Notified Body has to be involved and what it will expect to see when it is.MDR Annexes IX to XI |
| EU AI Act applicability | Whether your product also counts as a high-risk artificial intelligence system. A yes brings a second set of obligations on top of the medical device work, with its own deadline of 2 August 2028.Regulation (EU) 2024/1689 |
For an in vitro diagnostic, the same work runs against IVDR 2017/746 and its own classification rules.
How the determination is made, and against what
The determination starts from your own input. You answer a set of simplified questions about your product in ordinary language, without having to know the regulatory terms before you begin.
Those answers then run through the Venitara algorithms, which apply the rule text to what you have described and return a risk class with the rules that produce it.
A senior regulatory expert then checks that determination against the rule text before it reaches you. Where a rule is genuinely ambiguous, the reasoning is written down, so the position can be defended when someone challenges it.
Venitara has worked in cooperation with ten to twelve Notified Bodies and delivered more than forty regulatory projects.
What you can do with the result
You can answer the question an investor asks first, and cite the rule you answered it from.
You can budget. The class sets the evidence, and the evidence sets most of what the route costs and how long it takes.
The team also stops arguing about it. A written rationale with a rule behind it ends a conversation that otherwise runs for months.
The two levels for this product
Explore | Attest | |
|---|---|---|
| What you get | An indicative classification built from your own answers | The classification rationale read by a named senior expert and attested |
| Human review | No expert review | Reviewed by a named senior regulatory expert |
| What it may claim | An indicative view of how the product is likely to be regulated | That this rationale was ready for submission on the date it was read |
| The mark | A notice that no regulatory expert has read it | The Attestation seal, on the document |
The Venitara Attestation records that a named senior regulatory expert has reviewed this document against the Venitara rubric, confirming concordance with the applicable regulatory requirements and assessing it as ready for submission at a defined point in time. It is not a conformity assessment under Regulation (EU) 2017/745, regulatory approval, a Notified Body certificate, or a guarantee of approval.
Scope and limits
Three things this product does not do
Decide your classification.
You are the manufacturer, so the classification is yours to set and yours to sign. Venitara gives you the reasoning behind it and the evidence that holds it up. Where a Notified Body is involved it checks that reasoning, and if you still disagree, the competent authority in your country decides under MDR Article 51.
Guarantee that a classification is accepted.
A determination can be challenged. What the rationale does is make the challenge answerable.
Submit on your behalf.
You remain the manufacturer, and the submission is made in your name.
Where this leads
Market Ready.
If more than one market is in play, the order you take them in decides the evidence you have to fund. That decision is cheaper before the roadmap is fixed than after.
Company Ready.
The quality system has to exist before most of the technical file can be built inside it.
Common questions
What if we are not a medical device at all?+
That is one of the outcomes. The qualification determination is the first thing the work does, and being told you are outside the regulation is a result worth having in writing.
Our product changes. Does the classification?+
It can. A change to the intended purpose is the usual cause. The rationale is dated and tied to the intended purpose it was written against, so you can see when it stopped describing the product.
Can we do this ourselves with the free Compass?+
The Compass gives you an indicative view in about ten minutes and no expert has read it. This is the same question answered by a named person against the rule text.
Does this cover the EU AI Act?+
The applicability determination does. Whether your product is a high-risk AI system under Regulation (EU) 2024/1689 is answered here. The conformity work that follows from a yes is separate.
Want your device class settled, with the rule behind it in writing?
If you are still working out where to begin, the free MedTech Compass takes about ten minutes.
Free · AI generated · 10 mins