Regulatory impact assessment for medical devices
A useful impact assessment explains the evidence, conclusion and next action. It should let another qualified reviewer understand why a source was considered relevant and how the decision reached affected records.
1. Establish applicability
Compare the source’s jurisdiction, scope, device type, publication status, effective date and transition provisions with the company and portfolio baseline.
2. Assess products and evidence
For potentially affected products, review intended purpose, classification, registrations, claims, risk controls, clinical evidence, verification and validation, labeling, PMS and PMCF as applicable.
3. Assess controlled processes
Identify which procedures govern surveillance, applicability decisions, document control, change control and specialist evidence. Cite the relevant process section and explain the rationale for each proposed revision.
4. Create and close actions
Convert accepted recommendations into tasks with ownership, due dates, deliverables and review status. Close the case only when decisions and completion evidence are traceable to the original source.
- Source and version captured
- Applicability conclusion approved
- Products and processes linked
- Actions assigned and verified
- Final decision retained in the audit trail