The Importance of State of the Art in Article 61.10 Pathway for Clinical Evaluation

Hi Dear,

I hope you're enjoying the summer sunshine

Today, I want to discuss one of the most critical aspects of choosing Article 61.10 for clinical evaluation: the importance of state of the art (SOTA).

Misconceptions About Article 61.10

Article 61.10 provides an alternative pathway for demonstrating compliance with safety and performance requirements, but it's not a loophole to bypass clinical data when necessary. Let’s clear up some misconceptions.

What is Article 61.10?

Article 61.10 allows manufacturers to justify compliance without clinical data only when clinical data is deemed inappropriate or irrelevant. This means that the device:

• Must not be an implantable or Class III device.
• Should have safety and performance demonstrated through non-clinical data like performance evaluation, bench testing, and pre-clinical studies.
• Typically, it does not have direct clinical claims or measurable clinical benefits requiring clinical data.

Importance of State of the Art (SOTA)

Understanding and documenting the state of the art (SOTA) is crucial when choosing Article 61.10. Here’s why:

Establishing Current Best Practices

• Comprehensive Literature Review: Conduct a thorough literature review to determine the current best practices and technologies in the field.

Demonstrating Compliance

• Non-Clinical Data: Use bench testing, performance evaluations, and pre-clinical studies to show that your device meets the safety and performance requirements.
• Risk Management Analysis: A detailed risk management analysis ensures all potential risks are identified and mitigated, supporting your justification for using non-clinical data.

Justification and Documentation

• Detailed Justification: Provide a clear and detailed justification for using Article 61.10. This should include why clinical data is inappropriate and how non-clinical data sufficiently demonstrates compliance.
• Comprehensive CER: Ensure your Clinical Evaluation Report (CER) includes all relevant non-clinical data, risk management outcomes, and a robust literature review.

When Can Article 61.10 Be Used?

Article 61.10 is applicable in specific scenarios:

• Minimal Human Interaction: Devices that do not interact directly with the human body or have minimal interaction.
• Adequate Non-Clinical Data: When the device’s performance and safety can be demonstrated through non-clinical means.
• Low Degree of Novelty: Devices with well-documented safety and performance profiles from similar devices.

What Article 61.10 Is Not

Article 61.10 is not an excuse to avoid clinical investigations when necessary. If there are relevant clinical endpoints and insufficient clinical data, clinical investigations must be conducted.

Conclusion

Using Article 61.10 requires a thorough justification process and is only applicable in specific cases where clinical data is genuinely inappropriate. Establishing the state of the art (SOTA) is a critical component of this process.

Feel free to share this information with your colleagues to stay updated!

Stay safe and take care.

Peace ✌️,

Hatem