How Sted decides what applies to you
Sted works out what applies to you from your onboarding answers: where you operate, what you sell, what data you hold and who your customers are. Its rules compare those facts with 85 standards, regulations and schemes, then recommend the ones that apply or would help, each with its reasons. A medical device also gets a class for each market.
What this is
Steward asks, the rules decide. He gathers the facts in the onboarding conversation, but he doesn’t decide what applies to you. Sted’s rules do, from the answers you recorded. The same facts always give the same result, and every recommendation shows its reasons.
Applicability is the question of whether a law, regulation or standard reaches your organisation at all. Getting it wrong costs you twice: work on rules that never applied, or a gap an auditor or a customer finds first.
Sted’s catalogue holds 85 standards, regulations and schemes across eight areas: privacy, information security, AI governance, medical devices, payments and financial services, NHS digital health, quality and environmental, and sustainability reporting.
Where to find it
While onboarding runs, each phase ends with a count of the standards that now apply to you. Once it is finished, open Standards under your organisation’s name in the sidebar to see every recommendation and its reasons.
Summary, in the same group, holds the facts the rules used. Its What applies to you card states them as sentences, and Products and systems lists each product with its device classification once there is one.
On a phone, the sidebar sits behind the Menu button.
How it works
From answers to recommendations
Every standard, regulation and scheme in the catalogue has its own applicability rules. Sted runs them against your facts and gives each one an outcome: it applies, applies in part, applies indirectly through a customer, does not apply, or is pending more information. Standards that do not apply to you by law, but would help you win or keep customers, are recommended too.
Reading a recommendation
- Open Standards and find a recommended standard.
- Read its Basis, Outcome and Confidence rows.
- Open Why this is recommended to see the reasons.
The Basis row says what kind of obligation the standard is, whatever your situation. Whether it applies to you is what Outcome and the reasons are for.
| Basis | What it means | For example |
|---|---|---|
| Legal requirement | A law or regulation. | UK GDPR |
| Contractual requirement | Not a law, but binding once a contract brings it in. | PCI DSS, through your card payment agreements |
| Customer requirement | Voluntary, but customers often ask for it before they buy. | SOC 2 |
| Mixed requirement | Voluntary, but customers, contracts or regulators can each call for it. | ISO 27001, ISO 13485 |
| Voluntary | Something you adopt by choice. | ISO 42001 |
The Outcome row appears when the answer is something other than a plain “applies”.
Classifying a medical device
If your answers say you make a medical device, Home raises a task for each product.
- Open the task Classify your medical device, followed by the product’s name, on Home.
- Answer Steward’s questions about the product.
- Read the card headed Classification result for and the product’s name, at the end of the conversation.
For each market, the card shows the regulation, the class, the rule that produced it, the reasoning, and a confidence level. Where no class applies, it says why in plain words: not a medical device, borderline and in need of review, an in vitro diagnostic or combination product outside this classification, or pending more information.
Sted classifies a device for six markets. The first task asks whether the product is a medical device and how it works, facts every market’s rules use, and gives it an EU class if you sell in the EU. If you sell in any of the other markets, a second task follows with their own questions.
| Market | Regulation |
|---|---|
| EU | EU MDR |
| Northern Ireland | EU MDR |
| Great Britain | UK MDR 2002 |
| Canada | Medical Devices Regulations (SOR/98-282) |
| Australia | Therapeutic Goods (Medical Devices) Regulations 2002 |
| United States | FDA device regulations, using the FDA product code you confirm |
The classification is information for you and your notified body or regulator to check, not a verdict. Keep the rationale with your technical documentation, because whoever assesses the device will test the same reasoning.
When the answer is “pending”
A pending outcome means a fact is missing. Reopen your answers from Summary with Review your onboarding answers, fill the gap, and the outcome updates.
Permissions
| Action | Administrator | Policy and Process Owner | Reviewer | Personnel |
|---|---|---|---|---|
| See the standards and their basis | Yes | Yes | Yes | Yes |
| See each recommendation’s outcome, confidence and reasons | Yes | Yes | No | No |
| Read the facts on Summary | Yes | Yes | Yes | Yes |
| Adopt or remove a standard | Yes | Yes | No | No |
| Answer classification questions | Yes | Yes | No | No |
| Open a device’s classification result card | Yes | Yes | No | No |
Administrators and Policy and Process Owners choose which standards to adopt. They are also the only levels shown each recommendation’s reasons; everyone else sees the standards without them. The Onboarding row, where the questions live, is not in the sidebar for Reviewers and Personnel.
Limits and plan features
Device classification covers the markets above; a device sold elsewhere has no class from Sted yet.
Turning the standards you adopt into documents uses Update and generate framework, and Preview includes one free generation of your whole framework.
Related guides
- The onboarding conversation: where the facts behind every recommendation come from.
- Standards: adopting, removing and re-adding recommended standards.
- Organisation summary: the facts Sted holds about you, in one place.
- EU MDR: the EU’s device regulation and how its classes work.
- UK MDR 2002: the rules for placing a device on the market in Great Britain.
- Management-system registers: the scope, interested parties and obligations Sted drafts from the same answers.
Frequently asked questions
Is Sted’s medical device classification legally binding?
No. The result is information for you and your notified body or regulator to check, and they make the decision. Keep the rationale Sted shows with your technical documentation, and check it against the classification rules for each market.
Does an AI decide which regulations apply to my company?
No. Steward, the AI assistant, asks the questions and records your answers. Sted’s rules then work out what applies from those answers, so the same facts always give the same result.
Why does a standard say Pending more information?
Because Sted’s rules need a fact you have not given yet, often an answer you were unsure of. Reopen your answers from Summary, under your organisation’s name in the sidebar, with Review your onboarding answers, and the outcome updates once the gap is filled.
Which markets can Sted classify a medical device for?
The EU, the UK, Canada, Australia and the United States. Northern Ireland follows EU MDR, Great Britain UK MDR 2002, Canada the Medical Devices Regulations (SOR/98-282) and Australia the Therapeutic Goods (Medical Devices) Regulations 2002. In the United States the class follows the FDA product code you confirm. Sted does not classify devices for other markets yet.