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A device investigation safety process must capture failures as well as clinical events and connect them to the applicable reporting rules.
MDR investigation safety — Define the regulatory scope
MDR Article 80 addresses safety reporting in clinical investigations. MDCG 2020-10/1 provides operational guidance; assess the investigation route and any applicable vigilance interface.
MDR investigation safety — Build the working record
Build an intake form covering event seriousness, device deficiency, procedure relationship, causality, corrective action and follow-up. Assign medical assessment, technical investigation and reporting ownership with clear handoffs and backup coverage.
MDR investigation safety — Check before release
- Capture deficiencies even without observed injury.
- Reconcile site reports with device complaints.
- Check applicable reporting channel and timeframe.
MDR investigation safety — Record the decision and handover
Retain the assessment rationale and each follow-up submission. Reconcile the event log before analysis and closeout; do not copy medicinal product SUSAR rules into a device investigation without an applicability assessment.
Frequently asked questions
- Is every device malfunction a serious adverse event?
- No. Assess the event and deficiency definitions and relevant reportability criteria.
- Can technical teams decide medical seriousness alone?
- Use appropriate medical input and explicit responsibilities for the assessment.