Appendix to Clinical Evaluation Report

Demonstration of Equivalence

in accordance with MEDDEV 2.7/1 revision 4

1Summary

This annex to the clinical evaluation is used to determine equivalence of other medical devices and enable the use of clinical data with equivalent devices in order to show safety and performance of the device under evaluation.

Criteria for rating the equivalence are determined in chapter 3.3.1 of appendix “Clinical Data Identification Report”.

Conclusion concerning equivalence / Devices
1 / 2 / 3 / 4 / 5 / 6
Total clinical equivalence
Total technical equivalence
Total biological equivalence
Total equivalence is demonstrated
Effect on clinical performance and safety
//confirmation that the differences are not expected to affect the clinical performance and safety of the device under evaluation
Limitations of equivalence
//description of any limitations and gaps

1/3

2Evaluation of equivalence

2.1Device 1 //copy for each device

Picture / Device name / Model
//insert picture
Intended Use / CE-mark
Size/s / Accessories
Settings / Software version
Manufacturer / Relationship
If data from a non CE-marked device will be used
Regulatory status / Justification
//CE or other market authorization / // justification should explain if the clinical data is transferrable to the European population,and an analysis of any gaps to good clinical practices (such as ISO 14155) and relevantharmonised standards.
Clinical characteristics / Evaluation
used for the same clinical condition (including when applicable similar severity and stage of disease, same medical indication)
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.).
If applicable: is intended to deliver additional clinical effects beyond the specific intended use (purpose) for the device under evaluation
Disclosure of performance and safety deviation
the differences between the device under evaluation and the device presumed to beequivalent need to be identified, fully disclosed, and evaluated;
Justification for acceptance of performance and safety deviation
explanations should be given why the differences are not expected to significantly affect the clinical performance and clinical safety of the device under evaluation
Total clinical equivalence
Technical characteristics
be of similar design
Note: comparative drawings or pictures should be included in order to compare shapes and sizes
of elements that are in contact with the body;
used under the same conditions of use
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 under 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 basic 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

3References

//ifapplicable

1/3