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PMCF may reveal use outside a device’s stated intended purpose. That observation does not automatically establish that the new use is appropriate or safe. Retain the signal and explain what conditions it represents and how it affects the existing assessment.
Define the assessment
Compare observed use, the defined intended purpose and the scope of available clinical evidence. Keep the question open where details are missing. Distinguish a user account from a verified procedural record, and avoid implying that the PMCF activity encourages a new use.
Worked example
For example, a survey mentions use in a different patient group. The team does more than add it to positive experience counts. It investigates the group, any problems or events, and whether the account can be verified. Rather than creating a new claim, it routes the signal for authorised clinical and regulatory assessment.
Practical checks
- Describe concrete differences between intended purpose and the observed use.
- Record source, verification status and missing information together.
- Separate ownership of safety review from assessment of a new clinical claim.
Decision and limitations
Closure should show where the signal went and which conclusions are supported. A few favourable examples do not generalise to every condition of a new use. Identify further evidence or risk-assessment needs where appropriate; do not assume intended purpose expands outside authorised processes.
Frequently asked questions
- Is positive experience sufficient for a new-use claim?
- Not alone. Assess evidence quality, context and applicable assessment requirements separately.
- Should outside-purpose information be removed from a report?
- Do not conceal it. Evaluate it with context and limitations, then route it to appropriate oversight.