Clinical trials and validation studies are essential for medical devices to demonstrate safety and efficacy. The extent depends on device class and novelty. Options range from a literature review (existing data) to a full prospective clinical investigation.
Key Takeaways
- Clinical evidence requirements scale with device class and novelty.
- Literature review may suffice for equivalent devices.
- Prospective studies take 6-12 months — plan early.
- Ethics approval takes 2-4 months — submit ASAP.