Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Common clinical evaluation terms

safety

performance MDR Article 2: “the ability of a device to achieve its intended purpose as claimed by the manufacturer;” EN ISO 14155: “behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).”

benefit-risk

ISO/IEC Guide 51 (Safety Aspects: Guidelines for its inclusion in standards): “freedom from unacceptable risk”. MedDev2.7/1 rev 4: “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)

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.

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Annex X / Annex 7 / Article 61 clinical evaluation requirements…

MDD/AIMDD: “unless duly justified to rely on existing clinical data” MDR: it’s a bit more complicated, including caveats for equivalence, legacy devices and specific exempted devices…

By default, clinical investigations are required for Class III and implantable By default, PMS shall include PMCF The clinical evaluation and its documentation must be regularly updated with PMS data.

If not deemed necessary, “must be duly justified and documented”

MedDev 2.7/1 rev 4 (Clause 6.2.3) provides guidance on frequency of updates.

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