Obligation register, Region B
- 0 applicable obligations, 0 evidence items, 0 owners.
- 0 ruled out, with the answer that excluded each.
Legal Intelligence
Legal Applicability and Exposure
Determines which laws may apply from the entity, activity, contract, jurisdiction and legal triggers, and the exposure each implies.
Demonstration: Pellam Diagnostics Ltd (fictional) · Medical devices. Fictional data and a scripted answer.
The situation
- Organisation
- Pellam Diagnostics Ltd (fictional)
- Who is asking
- Head of legal and compliance
- Industry
- Medical devices
- What happened
- The company is about to start selling a device in a second region and must know which legal obligations come with it.
The question asked
Which obligations apply to us in the new region, given what we do there?
What it reads, and who can see the result
- Company profile answers formFacts about the business in the region, answered by the legal team.
- Obligation library registerSynthetic obligations with their conditions.
- Reads
- The answers the legal team gives, and the obligation library.
- Does not read
- Customer or patient data.
- Permission
- Legal team access to the library.
- Who sees it
- Legal, regulatory affairs and the commercial lead for the region.
Try it
Answer the questions about the organisation. Each rule becomes applicable, not applicable, or undetermined until the questions it depends on are answered: nothing is assumed.
| Obligation | Where | Status | Evidence and owner |
|---|---|---|---|
| Manufacturer registration Synthetic Device Act, s. 4 | Region B | UndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributor | None needed |
| Software as a device: clinical evaluation Synthetic Device Act, s. 9 | Region B | UndeterminedNeeds: Does the device contain software that influences a clinical decision | None needed |
| Patient data localisation Synthetic Data Code, art. 12 | Region B | UndeterminedNeeds: Will we store patient-identifiable data in the region | None needed |
| Local safety officer Synthetic Device Act, s. 15 | Region B | UndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributor; Do we have more than 50 employees in the region | None needed |
| Distributor due diligence Synthetic Device Act, s. 6 | Region B | UndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributor | None needed |
- Applies
- 0
- Does not apply
- 0
- Undetermined
- 5
- Answered
- 0 of 4
The answer
Simulated answer. Written for this fictional case, not produced by a live model. Only the figures in it are computed, from what you decided above.
0 obligations apply, 0 do not, and 5 cannot be decided yet.
Each obligation depends on specific facts about the business [S1]. Where a fact has not been given, the obligation is undetermined and the table says which question it needs; it is never assumed either way [S2].
For the obligations that apply, the register names the evidence to keep and the owner: 0 items of evidence across 0 owners. Answer the remaining questions to settle the rest.
Relies on: S1 · Obligation library, regional extractS2 · Company profile, answered
Review and approval
The head of legal and compliance decides. Approving records which obligations apply and who owns each. It does not file anything with a regulator and does not assert compliance.
Not ready to approve. 5 obligations are undetermined until the questions they depend on are answered. Answer them first; nothing is assumed.
In the product this is a different person with the right permission. Here you play that role to see the rule.
What it produces
Limits of this example
- The library is synthetic and illustrative.
- A rule can depend on facts the questions do not ask; a lawyer confirms the register.
- This is a scripted demonstration on fictional data. No model was called and no real organisation, person or result is shown.
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The Legal Intelligence story · This capability in the full register