Module 18 2021

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2/9/2021

Comparison of common clinical evaluation terms safety performance benefit-risk

ISO/IEC Guide 51 (Safety Aspects: Guidelines for its inclusion in standards) defines safety as “freedom from unacceptable risk”. MedDev 2.7/1 rev 4 defines clinical safety as “freedom from unacceptable clinical risks, when using the device according to the manufacturer’s Instructions for Use.” (ie freedom from unacceptable adverse events or side effects)

The Medical Devices Regulation defines performance in Article 2 as “the ability of a device to achieve its intended purpose as claimed by the manufacturer;” EN ISO 14155 defines clinical performance as “behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use,

Benefit-risk is an overall evaluation of the safety and

performance in comparison with safety and performances that can be achieved for other devices and treatment options intended for the same condition and patient population.

when correctly applied to appropriate subject(s).”

Comparison of common clinical evaluation terms

safety

performance

benefit-risk

ie, performance is the ability of a medical device to do what it’s supposed to do; safety is the ability to do this without causing unacceptable harm. “risk-benefit” is the balance between these two, in line with the current state of the art. Note: The Essential Requirements of both the Active Implantable Medical Devices Directive (90/385/EEC) and the Medical Devices Directive (93/42/EEC) require that both safety and performance be supported with clinical evidence, as well as the overall risk-benefit.

Article 2 (24)

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