[organization name]

Equivalence Table

Equivalence Table

[Device 1] [Device 2]
Identified
(under clinical (marketed device)
differences or
evaluation) Description of
1.TECHNICAL conclusion that
Description of characteristics and
CHARACTERISTICS there are no
characteristics and reference to
differences in the
reference to specifying specifying
characteristic
documents documents

Device is of similar
1.1
design
Used under similar
1.2
conditions of use
Similar specifications
and properties,
including
physiochemical
properties such as
intensity of energy, 1.3
tensile strength,
viscosity, surface
characteristics,
wavelength, and
software algorithms
Uses similar
deployment methods 1.4
where relevant
Has similar principles of
operation and critical
1.5
performance
requirements

Clinically
Scientific justification for why there would be no clinically significant difference in
significant
the safety and clinical performance of the device, OR
difference
a description of the impact on safety and or clinical performance
(Yes / No)

1.1 [Title of the scientific paper]

1.2 [Title of the scientific paper]
1.3 [Title of the scientific paper]
1.4 [Title of the scientific paper]
1.5 [Title of the scientific paper]
Appendix 5 – Equivalence Table ver. [version] from [date] Page 1 of 3

©2023 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.
[organization name]

[Device 1] [Device 2]
Identified
(under clinical (marketed device)
differences or
evaluation) Description of
2. BIOLOGICAL conclusion that
Description of characteristics and
CHARACTERISTICS there are no
characteristics and reference to
differences in the
reference to specifying specifying
characteristic
documents documents

Uses the same materials

or substances in contact
2.1
with the same human
tissues or bodily fluids
Similar kind and
duration of contact with
2.2
the same human tissues
or bodily fluids
Similar characteristics
regarding release of
substances, including 2.3
degradation products
and leachable

Clinically
Scientific justification for why there would be no clinically significant difference in
significant
the safety and clinical performance of the device, OR
difference
a description of the impact on safety and or clinical performance
(Yes / No)

2.1 [Title of the scientific paper]

2.2 [Title of the scientific paper]
2.3 [Title of the scientific paper]

[Device 1] [Device 2]
Identified
(under clinical (marketed device)
differences or
evaluation) Description of
3. CLINICAL conclusion that
Description of characteristics and
CHARACTERISTICS there are no
characteristics and reference to
differences in the
reference to specifying specifying
characteristic
documents documents

Same clinical condition

or purpose, including
3.1
similar severity and
stage of disease
Same part of the body 3.2
Similar population,
including with regard to
3.3
age, anatomy, and
physiology
Appendix 5 – Equivalence Table ver. [version] from [date] Page 2 of 3

©2023 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.
[organization name]

Same kind of user (e.g.,

health worker, nurse, 3.4
doctor, etc.)
Similar relevant critical
performance in view of
the expected clinical 3.5
effect for a specific
intended purpose

Clinically
Scientific justification for why there would be no clinically significant difference in
significant
the safety and clinical performance of the device, OR
difference
a description of the impact on safety and or clinical performance
(Yes / No)

3.1 [Title of the scientific paper]

3.2 [Title of the scientific paper]
3.3 [Title of the scientific paper]
3.4 [Title of the scientific paper]
3.5 [Title of the scientific paper]

Summary

Appendix 5 – Equivalence Table ver. [version] from [date] Page 3 of 3

©2023 This template may be used by clients of Advisera Expert Solutions Ltd. www.advisera.com in accordance with the License
Agreement.