Module 15 2022

5/19/2022

Early Stage CER

What is the State Of The Art ? • Current knowledge in this medical field? • What are the Therapeutic Alternatives? • Strengths / Weaknesses/ unmet need? • Risks (potential clinical hazards) / Benefits with Therapeutic Alternatives? What are current public data • From appropriate literature from benchmark/similar devices • Known/anticipated Adverse Events (types and frequency) • Performance endpoints? in each indication? • Safety endpoints (risks)? What evidence do we need to produce? • Risks to go into FMEA (ISO 14971:2019) • Design V&V activities (bench testing, biocompatibility, sterilization…) • Can I use an equivalence strategy? • Clinical performance vs clinical benefit

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From the Early Stage CER

• Prevents too late discovery of inadequate relevant clinical data • Prevents underestimating timelines and costs of necessary activities for full V&V

• Provides input to the Risk Analysis • Provides input to the V&V activities • Positions the device among alternatives(SOTA)

• Provides inputs on appropriate comparator devices (equivalent or similar or different) • Provides data to determine your Clinical Strategy (especially high risks devices) • Provides inputs on available clinical data to contextualise Safety and Performance requirements

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