Clinical Evaluations – Comparability of Medical Devices

The MEDDEV 2.7.1 document, which describes how to create a clinical evaluation, is not exactly new. Three years after publication of Revision 4, however, we have noted that in practice authorities and Notified Bodies are now taking the equivalence discussion, if applicable, very seriously. It is not sufficient anymore, to vaguely compare products and categorize them as “equal” or “similar”. Rather, all available product details are to need be discussed in detail.

It is, however, often very difficult, if not impossible, to research these details of competitor products at the desired depth. Reasons for the delay or even failure of a certification can often be found in the use of literature data that do not directly relate to the product to be evaluated. It is therefore of utmost importance to note that the products should be consistent in all essential characteristics.

This concerns the clinical characteristics (e.g., the same indication, the same purpose, the same body site, and comparable patient population with comparable clinical performance). It also concerns the technical characteristics (secondary materials, construction, design) as well as the biological characteristics (materials in body contact). It is unlikely that all these aspects will be equal. At this point, the impact of the distinction has to be discussed and evaluated. It should also be explained how gaps of proof can be closed. Documentation gaps, for instance technical or biological could be resolved by laboratory testing.

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