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.
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.)
Write to us. An expert will answer to your questions.