Medical device manufacturers in Australia related to the Demonstration of Equivalence is important for regulatory compliance and ensuring the safety and effectiveness of medical devices. Demonstrating equivalence is a crucial step in the regulatory process, as it helps establish that a new device is similar in safety and performance to a previously approved device. One of the key requirements for gaining approval for a medical device in Australia is demonstrating equivalence. This process involves showing that the new device is equivalent to a previously approved reference device in terms of safety, quality, and performance. https://mavenprofserv.com/demonstration-of-equivalence/

1. DEM O N STRA TIO N
OF EQUIVALENCE
www.m avenp ro fs erv.c o m

2. 01
02
03
DEMONSTRATION OF EQUIVALENCE
CHARACTERISTICS
CONCLUSION
C O N TEN T

3. Demonstration of Equivalence
The M D R (A nnex XIV, Part A ) es tab lis hes that, in o rd er
to d em o ns trate
devices, three
eq uivalenc e in relatio n to o ther
c harac teris tic s m us t b e c o ns id ered
when demonstrating equivalence: technical, biological,
and clinical. These characteristics shall be
investigated and differences between devices should
be disclosed.

4. Demonstration of equivalence shall be performed as
per the requirement of Part A, section 3 of Annex XIV
of EU-MDR.

5. Characteristics
Equivalence MDR, Annex XIV Part A (3)
MEDDEV 2.7/1 rev 4,
Appendix A1
Technical
The device is of similar design
Is used under similar
conditions of use
Be of similar design, and
Used under the same
conditions of use, and

6. Technical
Has similar specifications
and properties including
physicochemical properties
such as intensity of energy,
tensile strength, viscosity,
surface characteristics,
wavelength and software
algorithms;
Have similar specifications
and properties (e.g.
physicochemical properties
such as type and intensity
of energy, tensile strength,
viscosity, surface
characteristics, wavelength,
surface texture,
particle
nanotechnology,
porosity,
size,
specific
inclusions
mass, atomic
such as nitrocarburizing,
oxidability), and

7. Uses similar deployment Use similar deployment
methods, where relevant; has methods (if relevant),
similar principles of operation and
Technical
and critical performance
requirements.
have similar principles of
operation and critical
performance
requirements

8. Biological
The device uses the same
materials or substances in
contact with the same human
tissues or body fluids for a
similar kind and duration of
contact and similar release
characteristics of substances,
degradation
leachables.
including
products and
Exceptions can be foreseen for
devices in contact with intact
skin and minor components of
devices.
Use the same materials or
substances in contact with
the same human tissues or
body fluids. 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.

9. Clinical
The device is used for the
same clinical condition or
purpose, including similar
severity and stage of disease,
at the same site in the body, in
a similar population, including
as regards age, anatomy and
physiology; has the same kind
of user; has similar relevant
critical performance in view of
the expected clinical effect for
a specific intended purpose.
Be of similar design, and
Used for the same
(including
clinical
when
condition
applicable similar severity
and stage of disease, same
medical indication), and
Used for the same intended
purpose, and
Used at the same site in the
body, and
Used in a similar population
(this may relate to age,
gender, anatomy, physiology,
possibly other aspects), and

10. Conclusion
The characteristics listed in the first paragraph shall be similar to
the extent that there would be no clinically significant difference in
the safety and clinical performance of the device. Considerations of
equivalence shall be based on proper scientific justification.
For assuming equivalence, – all three characteristics (clinical,
technical, biological) need to be fulfilled; – similar means that no
clinically significant difference in the performance and safety of the
device would be triggered by the differences between the device
under evaluation and the device presumed to be equivalent

11. MDCG 2 0 2 0 - 5 Annex I , an example is provided for the
table that can be used to demonstrate equivalence. This
includes an exhaustive l ist of all the characteristics to be
assessed, also an additional column is there which
includes information on the result of this assessment and
any identified difference. At the end of table, a scientific
justification why there would be no clinically significant
difference in the safety and clinical performance of the
device is expected.

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