MEDDEV 2_12-2_05-2004_Clinical Evaluation - Post Market Clin(2)

-used for the same clinical condition or purpose; -used at the same site in the body;

-used in similar population (including age, anatomy, physiology); -have similar relevant critical performance according to expected clinical effect for specific intended use.

¾ Technical:

-used under similar conditions of use;

-have similar specifications and properties (e.g. tensile strength, viscosity, surface characteristics) -be of similar design;

-use similar deployment methods (if relevant); -have similar principles of operation

¾ Biological:

-use same materials in contact with the same human tissues or body fluids;

To be equivalent, the devices should have similarity with regard to the clinical, technical and biological parameters with special attention to the performance, principles of operation and materials; or if there are differences identified, an assessment and demonstration of the significance these might have on safety and performance must be documented.

For example, where the device under consideration and the device referred to in the published study has a new principle of operation, then the two devices cannot be considered equivalent. A new mechanism and action does not necessarily result in a new clinical benefit and therefore a specifically designed clinical investigation will be needed to provide data to demonstrate (or otherwise) the clinical benefit of the new device