After an implant change, trace which evidence needs review
Real sources · Illustrative request · Sample version
Customer question
A fictional product family changes its surface-processing method and has a clinical-evaluation baseline.
Which existing claims, sources and post-market clinical questions could this change affect?
Log version changes and new literature separately, then link them to affected claims and evidence tasks.
Evidence trace for one change
| Check / stage | Chart content |
|---|---|
| Baseline | Product family v1, evaluation report and risk-record versions |
| Change | Assumed surface-processing change; technical materials needed |
| Difference assessment | Check contact materials, release characteristics and clinical use |
| Quarterly update | Record affected claims, reusable sources, gaps and owners |
Workflow informed by MDCG 2020-7. The package maintains literature and differences, not manufacturer PMCF execution or regulatory responsibility.
Analysis excerpt
| Check | Finding / sample content | Use |
|---|---|---|
| Reuse of evidence | Prior sources are neither all discarded nor automatically reused | Document relevance to the change item by item |
| No literature change | A product change can still trigger a difference review | Report product changes and literature changes separately |
Delivery manifest
| File | Format | Contents |
|---|---|---|
| version-impact-register.xlsx | XLSX | Versions, changes, affected claims and reuse rationale. |
| quarterly-device-update.pdf | Quarterly scan summary, evaluation differences, evidence gaps and review status. | |
| clinical-source-index.csv | CSV | New/corrected sources, access dates, related questions and report locations. |
This is an illustrative formal delivery manifest. This pack supplies an HTML report, CSV tables and a source register. Agree formal formats, quantities and scope in the quote.
Acceptance criteria
- Evidence versions clearly correspond to product versions. The scope, original sources and unresolved questions of each update can be checked.
Sources
- MDCG 2020-7: Post-market clinical follow-up plan template
https://health.ec.europa.eu/document/download/a5cdb303-c782-4010-8723-7d389af678f7_en?filename=md_mdcg_2020_7_guidance_pmcf_plan_template_en.pdf - MDCG 2020-5: Clinical evaluation — equivalence
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf