Map a software-as-medical-device classification and registration path
Key facts
- Human involvement
- YellowClose supervision
- How AI is used
- From the product description, list candidate device classes, registration or exemption paths and evidence still required against the rules the lawyer has named.
- What the lawyer must review
- Decide with the regulatory adviser whether the product is a medical device
- Do not file from a generated pathway
- Written for / version
- US
Open a jurisdiction version of this task to see which instruments apply: US
Who does what
| Role | What they do |
|---|---|
| Assistance | Consider narrowly defined preparation support after confirming the tool’s capability and permitted scope. |
| Lawyer | Set the scope, supervise the work closely, verify every part relied on, resolve omissions and exceptions, and approve the exact output. |
Checklist
- Verify the applicable jurisdiction and the version of each relevant law, rule or instrument in force at the material time.
- Confirm the output against the client’s instructions and the complete relevant source material, including omissions or contradictions.
- Resolve exceptions and record the responsible lawyer’s approval of the exact output and intended use.