Regulatory Readiness Blueprint

A · Product boundary

Are you describing the whole product or one specific function or module?

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Product or function name, as the team actually calls it

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Current version or release identifier

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Is this function being added to a product already placed on the market?

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Module dependencies

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What other modules or shared functionality does it depend on, and what depends on it?

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Which external devices or systems does it operate, configure, control, enable or assist?

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Name of that device or system, if any

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Is the linked device a medical device, an IVD, or unknown?

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B · Workflow and outputs

Inputs — what information can enter in any supported configuration?

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Processing — what does the software do to those inputs?

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Processing, in your own words

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Generated output — what new information does it derive?

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Pass-through output — what does it only transmit or display unchanged?

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Outputs, in your own words

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Users — who directly receives or uses the output?

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Subject — who or what is the output about?

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Downstream action — what is someone expected to do because of the output?

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Patient-specific routes — how can individual patient information reach or leave the product?

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Healthcare or health context

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Human review before anything happens

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How far the software can act by itself

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Potential consequence of a wrong output

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Time-critical or emergency use?

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C · Claims inventory

Formal intended-purpose wording, if one exists

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Website or marketing wording

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Sales or procurement wording

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Demo screenshots or example outputs that imply a use

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Restrictive disclaimers used

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Exact disclaimer wording

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Any claimed technical control — what mechanism actually enforces it?

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Can someone outside the team verify that mechanism?

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D · Draft intended purpose

Saved statement

No intended-purpose version saved yet (Module 2).

E · Qualification assessment

Qualification assessment

Complete Module 2 to record this section.

Signals and questions are inputs to a professional qualification review. They are not a determination of device status or of which framework applies.

F · Preliminary classification position

Classification position

Complete Module 3 to record this section.

The class hypothesis is entered by the learner and is preliminary. It requires confirmation by a competent regulatory reviewer.

G · Conformity strategy

Product or function, version and supported configurations in scope

Complete Module 4 to record this section.

The route and notified-body entries are learner hypotheses for discussion. Nothing here states which conformity assessment route applies or whether a notified body is required.

H · Clinical evidence plan

Product or function and the intended-purpose wording this plan is written against

Complete Module 5 to record this section.

Gaps and actions are the learner's own. Nothing here states that the evidence is sufficient or that a clinical investigation is or is not required.

I · EU AI Act overlay

AI system or AI component, version and what it does

Complete Module 6 to record this section.

Role, route and high-risk entries are learner hypotheses. Nothing here determines AI Act high-risk status or the obligations that follow from it.

J · QMS and lifecycle plan

Lifecycle owners — who owns which decision, and what record proves it

Complete Module 7 to record this section.

Status entries are the learner's own view of each section. They are never scored, summed or converted into a readiness percentage.

Handoff for professional review

Confirm the qualification premise and, if it is a device, the applicable framework.

Confirm or correct the preliminary classification position and its rationale.

Confirm the applicable conformity assessment route and any notified-body involvement.

Review the claims inventory against the evidence plan and say which claims are not yet supportable.

Confirm the AI Act actor role and whether any high-risk route applies to this system.

Review the QMS and lifecycle plan against what the organisation can actually operate.