have similar specifications and properties (e.g. physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, 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 Note: for the evaluation of the technical characteristics, devices that achieve the same therapeutic result by different means cannot be considered equivalent; If measurements can be performed, are they equivalent? Note: clinically relevant specifications and properties should be measured both in the device evaluation and the device presumed to be equivalent, and presented in comparative tabulations Total technical equivalence Biological characteristics Use the same materials or substances Materials conform to relevant standards Or after chemical analysis: with the same chemical composition Similar residual compounds Similar leachates Similar extractables in contact with the same human tissues or body fluids Eliciting similar host reaction Similar (manner and extent of) integration into host tissue Similar Degradation time Similar degradation products Similar Generation of particles/debris Animal tests (list, specify: species, compare test conditions, rate similarity of results) Justification explaining any acceptable deviation Justification for device 1 //Note: Exceptions can be foreseen for devices in contact with intact skin and minor components of devices; in these cases risk analysis results may allow the use of similar materials taking into account the role and nature of the similar material. Different aspects of equivalence and compliance to different Essential Requirements can be affected by materials. Evaluators should consider biological safety (e.g. in compliance to ISO 10993) as well as other aspects necessary for a comprehensive demonstration of equivalence. Total biological equivalence References //if applicable
have similar specifications and properties (e.g. physicochemical properties such as type and intensity of energy, tensile strength, viscosity, surface characteristics, wavelength, 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 Note: for the evaluation of the technical characteristics, devices that achieve the same therapeutic result by different means cannot be considered equivalent; If measurements can be performed, are they equivalent? Note: clinically relevant specifications and properties should be measured both in the device evaluation and the device presumed to be equivalent, and presented in comparative tabulations Total technical equivalence Biological characteristics Use the same materials or substances Materials conform to relevant standards Or after chemical analysis: with the same chemical composition Similar residual compounds Similar leachates Similar extractables in contact with the same human tissues or body fluids Eliciting similar host reaction Similar (manner and extent of) integration into host tissue Similar Degradation time Similar degradation products Similar Generation of particles/debris Animal tests (list, specify: species, compare test conditions, rate similarity of results) Justification explaining any acceptable deviation Justification for device 1 //Note: Exceptions can be foreseen for devices in contact with intact skin and minor components of devices; in these cases risk analysis results may allow the use of similar materials taking into account the role and nature of the similar material. Different aspects of equivalence and compliance to different Essential Requirements can be affected by materials. Evaluators should consider biological safety (e.g. in compliance to ISO 10993) as well as other aspects necessary for a comprehensive demonstration of equivalence. Total biological equivalence References //if applicable
Template-MEDDEV271Rev4-Demonstration-of-Equivalence.docx