Medical devices that use clinical data from the literature of a well-established medical device with approved regulatory status to which the equivalency is claimed are classified as Non-CE marked active/non-active/software.
Demonstration of Equivalence
Identification of an equivalent device and demonstration of its technical, biological, and clinical equivalence with the medical device under clinical evaluation.
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What are the methods for identifying technical characteristics?
• Be of similar design.
• Used under the same conditions of use.
• For active medical device should have similar specifications and properties including physiochemical properties such as type and intensity of energy,
• Mechanical properties like tensile strength, viscosity, surface characteristics, wavelength, software algorithms, surface texture, porosity, particle size, nanotechnology, specific mass, atomic inclusions such as nitrocarburising, oxidability
• Use similar deployment methods (if relevant)
• Have similar principles of operation and critical performance requirements.
What are the methods for identifying Biological characteristics?
• Use the same materials or substances in contact with the same human tissues or body fluids.
• Similar kind and duration of contact
• Similar release characteristics of substances, including degradation products and leachable.
• Exceptions should be foreseen for devices in contact with intact skin and minor components of devices; in these cases, risk analysis results, shall allow the use of similar materials considering the role and nature of the similar material.
• Biological safety as per EN ISO 10993-1:2018 shall be provided. Refer to the biological evaluation procedure. A justification explaining the situation should be provided for any difference.
What are the methods for identifying Clinical characteristics?
• Used for the same clinical condition (including similar severity and stage of disease),
• Used by same kind of user;
• Used for the same intended purpose
• Used at the same site in the body
• Used in a similar population (this may relate to age, gender, anatomy, physiology, possibly other aspects)
• Not foreseen to deliver significantly different performances (in the relevant critical performances such as the expected clinical effect, the specific intended purpose, the duration of use, etc.)
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