When to use this worksheet
Use it at the start of a product-information review, evidence discussion, software change or market-source assessment. Complete one record for each materially different configuration or function. A commercial name is not enough when the name covers several versions or outputs.
Blank product-purpose record
| Field | What to record |
|---|---|
| Product and configuration | Model, formulation, software version, accessories and connected services needed for the function |
| Intended user | Person operating the product and any person receiving or acting on its information |
| Setting and conditions | Home, laboratory, professional or other setting; relevant environmental or operating conditions |
| Input | Material, specimen, physical signal or information supplied by a person or another system |
| Processing or function | What the product does to the input, including any calculation or transformation |
| Output | Measurement, material, display, score, notification, recommendation or physical action |
| Intended action | What the user is expected to understand, decide or do |
| Boundaries | Functions, users, settings or outcomes not covered by this description |
Worked example
Illustrative product: a wrist-worn activity product, model A, firmware 4.2 and application 7.1.
| Field | Example entry |
|---|---|
| Intended user | An adult using the product for personal activity tracking |
| Setting | Everyday walking and running; product worn according to the instructions |
| Input | Motion signals collected by the wrist-worn sensor |
| Function | Software identifies steps from the signal and aggregates them by day |
| Output | Daily step count and a trend shown in the application |
| Intended action | The user reviews personal activity over time |
| Boundary | This record does not describe diagnosis, monitoring of a disease, energy expenditure or a clinical outcome |
The example distinguishes the measured signal, calculation and display. It does not claim that the product is accurate for every user or establish its regulatory status.
Test the wording
Compare the completed record with packaging, instructions, application screens, distributor text and professional communications. Mark each statement that adds a user, condition, function or outcome not present in the record. Resolve the difference by changing the statement or documenting the additional basis; do not simply adopt the broadest wording.
Record changes
Repeat the review when a formulation, component, algorithm, application, accessory, intended user or output changes. Record the previous and new configuration, the reason for the change and the person who approved the revised description.
Market context
This worksheet prepares a product description. It does not classify a product or determine authorisation. After completing it, use current official sources for the market concerned.