Product(s):

Part 1: General principles

EP 1: Use of medical devices not to compromise health and safety

Part 1. General principles Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
1 Use of medical devices not to compromise procedure applied
health and safety
1 A medical device is to be designed and produced in a way
that ensures that:
a) the device will not compromise the clinical
condition or safety of a patient, or the safety and
health of the user of any other person, when the
device is used on a patient under the conditions
and for the purposes for which the device was
intended and, if applicable, by a user with
appropriate technical knowledge, experience,
education, or training; and
b) any risks associated with the use of the device are:
(i) acceptable risks when weighed against the
intended benefit to the patient; and
(ii) compatible with a high level of protection of
health and safety.

Post: PO Box 100 Woden ACT 2606 ABN: 40 939 406 804
Phone: 1800 020 653 Web: [Link]
EP 2: Design and construction of medical devices to conform with safety principles

Part 1. General principles Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
2 Design and construction of medical devices to procedure applied
conform with safety principles
2 (1) The solutions adopted by the manufacturer for the
design and construction of a medical device must
conform with safety principles, having regard to the
generally acknowledged state of the art.
(2) Without limiting subclause (1), in selecting appropriate
solutions for the design and construction of a medical
device so as to minimise any risks associated with the
use of the device, the manufacturer must:
a) first, identify hazards and associated risks arising
from the use of the device for its intended purpose,
and foreseeable misuse of the device; and
b) second, eliminate, or reduce, these risks as far as
possible by adopting a policy of inherently safe
design and construction; and
c) third, if appropriate, ensure that adequate
protection measures are taken, including alarms if
necessary, in relation to any risks that cannot be
eliminated; and
d) fourth, inform users of any residual risks that may
arise due to any shortcomings of the protection
measures adopted.
(3) In paragraph 2 (d):
residual risk, for a medical device, means the risk
remaining after the measures described in paragraphs
(2) (a), (b) and (c) have been applied.

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EP 3: Medical devices to be suitable for intended purpose

Part 1. General principles Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
3 Medical devices to be suitable for intended procedure applied
purpose
3 A medical device must:
a) Perform in a way intended by the manufacturer;
and
b) be designed, produced and packaged in a way
that ensures that it is suitable for one or more of
the purposes mentioned in the definition of
medical device in subsection 41BD(1) of the Act.

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EP 4: Long-term safety

Part 1. General Principles Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
4 Long-term safety procedure applied

4 A medical device must be designed and produced in a way

that ensures that if:
a) the device is used within the period, indicated by
the manufacturer, in which the device can be
safely used; and
b) the device is not subjected to stresses that are
outside the stresses that can occur during normal
conditions of use; and
c) the device is regularly maintained and calibrated in
accordance with the manufacturer’s instructions;
the characteristics and performances mentioned in clauses
1, 2 and 3 are not adversely affected.

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EP 5: Medical devices not to be adversely affected by transport or storage
Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 1. General principles
standard or other
procedure applied
5 Medical devices not to be adversely affected
by transport or storage
5 A medical device must be designed, produced, and packed
in a way that ensures that the characteristics and
performance of the device when it is being used for its
intended purpose will not be adversely affected during
transport and storage that is carried out taking account of
the instructions and information provided by the
manufacturer.

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EP 6: Benefits of medical devices to outweigh any undesirable effects

Part 1. General principles Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
6 Benefits of medical devices to outweigh any procedure applied
undesirable effects
6 The benefits to be gained from the use of a medical device
for the performance intended by the manufacturer must
outweigh any undesirable effects arising from its use.

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Part 2: Principles about design and construction

EP 7: Chemical, physical, and biological properties

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
7 Chemical, physical, and biological properties procedure applied
7.1 Choice of materials
In ensuring that the requirements of Part 1 are met in
relation to a medical device, particular attention must be
given to:
(a) the chemical and physical properties of the
materials used in the device; and
(b) the compatibility between the materials used and
biological tissues, cells, body fluids and specimens;
having regard to the intended purpose of the device.
7.2 Minimisation of risks associated with contaminants
and residues
(1) A medical device must be designed, produced, and
packed in a way that ensures that any risks associated
with contaminants and residues that may affect a
person who is involved in transporting, storing or using
the device, or a patient, are minimised, having regard to
the intended purpose of the device.
(2) In minimising risks, particular consideration must be
given to the likely duration and frequency of any tissue
exposure associated with the transportation, storage, or
use of the device.
7.3 Ability to be used safely with materials, etc.
(1) A medical device must be designed and produced in a
way that ensures that the device can be used safely

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
with any material, substance, or gas with which the procedure applied
device may come into contact during normal use or use
in routine procedures.
(2) If the device is intended to be used to administer
medicine, it must be designed and produced in a way
that ensures that the device:
(a) is compatible with the provisions and restrictions
applying to the medicine to be administered; and
(b) allows the medicine to perform as intended.
7.4 Verification of incorporated substance
(1) If a medical device incorporates, or is intended to
incorporate, as an integral part, a substance that, if
used separately, might be considered to be a medicine
that is intended to act on a patient in a way that is
ancillary to the device:
(a) the safety and quality of the substance must be
verified in accordance with the requirements for
medicines; and
(b) the ancillary action of the substance must be
verified having regard to the intended purpose of
the device.
(2) For the purposes of this clause, any stable derivative of
human blood or human plasma is considered to be a
medicine.
7.5 Minimisation of risks associated with leaching
substances
A medical device must be designed and produced in a way
that ensures that any risks associated with substances that
may leach from the device are minimised.
7.6 Minimisation of risks associated with ingress or egress
of substances
A medical device must be designed and produced in a way
that ensures that any risks associated with unintentional

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
ingress of substances into, or unintentional egress of procedure applied
substances out of, the device are minimised, having regard
to the nature of the environment in which the device is
intended to be used.
7.7 Minimisation of risks associated with nanomaterials
(1) A medical device must be designed and produced in a
way that ensures that any risks associated with the size
and the properties of particles which are, or can be,
released into a patient’s or user’s body are minimised.
(2) In minimising risks, particular attention must be given to
the use of nanomaterials.
(3) Subclause (1) does not apply to particles that come
into contact with intact skin only.

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EP 8: Infection and microbial contamination

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
8. Infection and microbial contamination
procedure applied
8.1 Minimisation of risk of infection and contamination
(1) A medical device must be designed and produced in a
way that ensures that the risk of infection to a patient, a
user, or any other person, is eliminated or minimised.
(2) The device must be designed in a way that:
(a) allows it to be easily handled; and
(b) if appropriate, minimises contamination of the
device or specimen by the patient, user, or other
person; and
(c) if appropriate, minimises contamination of the
patient, user or other person by the device or
specimen.
8.2 Control of animal, microbial or recombinant tissues,
tissue derivatives, cells, and other substances
(1) This clause applies in relation to a medical device that
contains:
(a) tissues, tissue derivatives, cells or substances or
animal origin that have been rendered non-viable;
and
(b) tissues, tissue derivatives, cells, or substances of
microbial or recombinant origin.
(2) If the tissues, tissue derivatives, cells or substances
originated from animals, the animals must have been
subjected to appropriate veterinary controls and
supervision, having regard to the intended use of the
tissues, tissue derivatives, cells, or substances.
(3) If the medical device contains tissues, tissue

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
derivatives, cells or substances of animal origin, a standard or other
record must be kept of the country of origin of each procedure applied
animal from which the tissues, tissue derivatives, cells
or substances originated.
(4) The processing, preservation, testing and handling of
tissues, tissue derivatives, cells or substances of
animal, microbial or recombinant origin must be carried
out in a way that ensures the highest standards of
safety for a patient, the user of the device, and any
other person.
(5) In particular, the production process must implement
validated methods of elimination, or inactivation, in
relation to viruses and other transmissible agents.
Note: This may not apply to certain IVD medical devices if the
characteristics mentioned in subclause 8.2(5) are integral to the
intended purpose of the IVD medical device.
8.3 Medical devices to be supplied in a sterile state
(1) This clause applies in relation to a medical device that
is intended by the manufacturer to be supplied in a
sterile state.
(2) The device must be designed, produced and packed in
a way that ensures that the device is sterile when it is
supplied, and will remain sterile, if stored and
transported in accordance with the directions of the
manufacturer, until the protective packaging is opened
or damaged.
(3) The device must be produced and sterilised using an
appropriate validated method.
(4) The device must be produced in appropriately
controlled conditions.
8.4 Medical devices to be supplied in a non-sterile state
(1) A medical device that is intended by the manufacturer
to be supplied in a non-sterile state must be packed in
a way that ensures that the device maintains the level

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
of cleanliness stipulated by the manufacturer. standard or other
procedure applied
(2) If the device is intended to be sterilised before it is
used, the device must be packed in a way that:
(a) ensures that the risk of microbial contamination is
minimised; and
(b) is suitable, having regard to the method of
sterilisation that the manufacturer indicates is to be
used for the device.
(3) The device must be produced in appropriately
controlled conditions.
8.5 Distinction between medical devices supplied in sterile
and non-sterile state
If a medical device is supplied in both a sterile state and a
non-sterile state, the information provided with the device
must clearly indicate whether the device is in a sterile state
or a non-sterile state.

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EP 9: Construction and environmental properties

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
9 Construction and environmental properties procedure applied

9.1 Medical devices intended to be used in combination

with other devices or equipment
A medical device that is intended by the manufacturer to be
used in combination with another medical device or other
equipment (including a connection system) must be
designed and produced in a way that ensures that:
(a) the medical device, and any other device or
equipment with which it is used, operate in a safe
way; and
(b) the intended performance of the device, and any
other device or equipment with which it is used, is
not impaired.
9.2 Minimisation of risks associated with use of medical
devices
A medical device must be designed and produced in a way
that ensures that, as far as practicable, the following risks
are removed or minimised:
(a) the risk of injury arising from the physical features
of the device;
(b) any risks associated with reasonably foreseeable
environmental conditions
(c) the risk of reciprocal interference involving other
devices that are normally used in an investigation
or treatment of the kind for which the device is
intended to be used;
(d) any risks arising if maintenance or calibration of the
device is not possible;

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
(e) any risks associated with the ageing of materials
used in the device;
(f) any risks associated with the loss of accuracy of
any measuring or control mechanism of the
device;
(g) the risk of fire or explosion occurring during normal
use of the device, and in the event of a single fault
condition, especially if the device is intended to be
exposed to flammable substances or substances
that can cause combustion;
(h) the risks associated with disposal of any waste
substances.

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EP 10: Medical devices with a measuring function

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
10 Medical devices with a measuring function procedure applied
10 (1) A medical device that has a measuring function must
be designed and produced in a way that ensures that
the device provides accurate, precise and stable
measurements within the limits indicated by the
manufacturer and having regard to the intended
purpose of the device.
(2) The measurement, monitoring and display scale of the
device must be designed and produced in accordance
with ergonomic principles, having regard to the
intended purpose of the device.
(3) The measurements made by the device must be
expressed:
(a) in Australian legal units of measurement or be
compared to at least one point of reference
indicated in Australian legal units of measurement;
or
(b) if the device measures a physical quantity for
which no Australian legal unit of measurement has
been prescribed under the National Measurement
Act 1960, in units approved by the Secretary for
the particular device.

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EP 11: Protection against radiation

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
11 Protection against radiation procedure applied

11.1 Minimisation of exposure to radiation

A medical device must be designed and produced in a way
that ensures that the exposure of a patient, the user, or any
other person, to radiation is minimised, having regard to the
levels of radiation required to enable the device to perform
its therapeutic and diagnostic functions and the intended
purpose of the device.
11.2 Medical devices intended to emit radiation
(1) This clause applies in relation to a medical device that
is intended by a manufacturer to emit hazardous levels
of visible or invisible radiation because the emission is
necessary for a specific medical purpose, the benefit of
which is considered to outweigh the risks inherent in
the emission.
(2) The device must be designed and produced in a way
that ensures that the user can control the level of the
emission.
(3) The device must be designed and produced in a way
that ensures the reproducibility and tolerance of
relevant variable parameters.
(4) If practicable, the device must be fitted with a visual
indicator or an audible warning, or both, that operates if
potentially hazardous levels of radiation are emitted.
11.3 Minimisation of exposure to unintended radiation
A medical device must be designed and produced in a way
that ensures that the exposure of a patient, the user, or any
other person, to the emission of unintended, stray, or
scattered radiation is minimised.

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
11.4 Operating instructions procedure applied
The operating instructions for a medical device that emits
radiation must include detailed information about the
following matters:
(a) the nature of the radiation emitted;
(b) the means by which patients and users can be
protected from the radiation;
(c) ways to avoid misusing the device
(d) ways to eliminate any risks inherent in the
installation of the device.
11.5 Medical devices intended to emit ionising radiation –
additional requirements
(1) This clause applies, in addition to clauses 11.1 to 11.4,
in relation to a medical device that is intended by the
manufacturer to emit ionising radiation.
(2) The device must be designed and produced in a way
that ensures that, if practicable, the quantity, geometry
and energy distribution (or quality) of radiation emitted
can be controlled and varied, having regard to the
intended purpose of the device.
(3) If the device is intended to be used for diagnostic
radiology, the device must be designed and produced
in a way that ensures that, when used in relation to a
patient for a purpose intended by the manufacturer;
(a) the device achieves an appropriate image or
output quality for that purpose; and
(b) the exposure of the patient, or the user, to radiation
is minimised.
(4) if the device is intended to be used for therapeutic
radiology, the device must be designed and produced
in a way that ensures that the delivered dose of
radiation, the type and energy of the radiation beam,
and, if appropriate, the energy distribution of the

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
radiation beam, can be reliably controlled and procedure applied
monitored.

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EP 12: Medical devices connected to or equipped with an energy source

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
12 Medical devices connected to or equipped
procedure applied
with an energy source
12 Programmed or programmable medical device or
software that is a medical device
(1) A programmed or programmable medical device, or
software that is a medical device, that is intended to
make use of either or both of data and information
must be designed and produced in a way that
ensures that:
(a) the safety, performance, reliability, accuracy,
precision, useability, security and repeatability of
the device are appropriate for the intended
purpose of the device; and
(b) any consequent risks, or impairment of
performance, associated with one or more fault
conditions is eliminated or appropriately
reduced; and
(c) the device is resilient with respect to interactions
that could occur during the use of the device
and that could result in unsafe performance of
the device; and
(d) if relevant to the safety of a patient, or the safety
and health of the user or any other person, the
device provides suitable warnings in a timely
manner:
(i) following the disruption to services upon
which the device is dependent for the
device’s operation; and
(ii) following the performance of the device
being adversely affected; and

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
(e) if relevant to the safety of a patient, or the safety standard or other
and health of the user or any other person, the
device provides a means by which the user can
verify correct operation of the device; and
(f) if relevant to the safety of a patient, or the safety
and health of the user or any other person, the
integrity and quality of the data or information is
maintained; and
(g) if relevant, the privacy of the data or information
is maintained.
(2) A programmed or programmable medical device, or
software that is a medical device, must be
developed, produced, and maintained having regard
to the generally acknowledged state of the art
(including for design, development life cycle,
development environment, version control, quality
and risk management, security, verification, and
validation, change and configuration management
and problem resolution).
(3) A programmed or programmable medical device, or
software that is a medical device, that is intended to
be used in combination with computing platforms
must be designed and developed taking into
account the capability, resources and configuration
of the platforms and the external factors (including
information technology environments) related to the
use of the platforms.
(4) The manufacturer of a programmed or
programmable medical device, or software that is a
medical device, must provide instructions or
information with the device that sets out
requirements (including requirements about
hardware, software, information technology
environments and security measures) necessary to
operate the device as intended.

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
(5) A programmed or programmable medical device, or standard or other
software that is a medical device, must be designed,
produced and maintained with regard to best
practice in relation to software, security and
engineering to provide cybersecurity of the device,
including where appropriate the following:
(a) protection against unauthorised access,
unauthorised influence or unauthorised
manipulation;
(b) minimisation of risks associated with known
cybersecurity vulnerabilities (including either or
both of remediation of known vulnerabilities and
application of compensating controls);
(c) facilitation of the application of updates, patches,
compensating controls, and other
improvements;
(d) disclosure of known vulnerabilities in the device
or its components and associated mitigations;
(e) making available sufficient information for a user
to make decisions with respect to the safety of
applying, or not applying, updates, patches,
compensating controls, and other
improvements.
(6) The manufacturer of a programmed or
programmable medical device, or software that is a
medical device, having regard to the intended
purpose of the device, the generally acknowledged
state of the art and best practice, must ensure that
the data that influences the performance of the
device is:
(a) representative; and
(b) of sufficient quality; and
(c) maintained to ensure integrity; and
(d) managed to reduce bias.

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
12.2
standard or other
Safety dependent on internal power supply
procedure applied
(1) This clause applies in relation to a medical device if
the safety of a patient on whom the device is to be
used will depend on an internal power supply for the
device.
(2) The device must be fitted with a means of
determining the state of the power supply.
12.3 Safety dependent on external power supply
(1) This clause applies in relation to a medical device if
the safety of a patient on whom the device is to be
used will depend on an external power supply for the
device.
(2) The device must be fitted with an alarm system that
indicates whether a power failure has occurred.
12.4 Medical devices intended to monitor clinical
parameters
A medical device that is intended by the manufacturer to
be used to monitor one or more clinical parameters of a
patient must be fitted with an appropriate alarm system
to warn the user if a situation has developed that could
lead to the death of the patient or a severe deterioration
in the state of the patient’s health.
12.5 Minimisation of risk of electromagnetic fields
A medical device must be designed and produced in a
way that ensures that the risk of an electromagnetic field
being created that could impair the operation of other
devices or equipment being used in the vicinity of the
medical device is minimised.
12.6 Protection against electrical risks
A medical device must be designed and produced in a
way that ensures that, as far as possible, when the
device is installed correctly, and the device is being used
for an intended purpose under normal conditions of use
and in the event of a single fault condition, patients,

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
users, and any other persons, are protected against the
risk of accidental electric shock. procedure applied
12.7 Protection against mechanical risks
A medical device must be designed and produced in a
way that ensures that a patient, the users and any other
person, is protected against any mechanical risks
associated with the use of the device.
12.8 Protection against risks associated with vibration
(1) A medical device must be designed and produced in
a way that ensures that any risks associated with
vibrations generated by the device are minimised.
(2) If vibrations are not part of the intended performance
of the device, particular attention must be given to
relevant technical progress, and the available
means, for limiting vibrations, particularly at source.
12.9 Protection against risks associated with noise
(1) A medical device must be designed and produced in
a way that ensures that any risks associated with
noise emitted by the device are minimised.
(2) If noise is not part of the intended performance of
the device, particular attention must be given to
relevant technical progress, and the available
means, for reducing the emission of noise,
particularly at source.
12.10 Protection against risks associated with terminals
and connectors
A medical device that is intended by the manufacturer to
be connected to an electric, gas, hydraulic, pneumatic or
other energy supply must be designed and produced in
a way that ensures that any risks to the user associated
with the handling of a terminal or connector on the
device, in relation to the energy supply, are minimised.
12.11 Protection against risks associated with heat

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
A medical device must be designed and produced in a
way that ensures that, during normal use, any accessible procedure applied
part of the device (other than any part intended by the
manufacturer to supply heat or reach a given
temperature), and any area surrounding an accessible
part of the device, does not reach a potentially
dangerous temperature.
12.12 Protection against risks associated with
administration of energy or substances
(1) This clause applies in relation to a medical device
that is intended by the manufacturer to be used to
administer energy or a substance to a patient.
(2) The device must be designed and produced in a
way that ensures that:
(a) the delivered rate and amount of energy, or of
the substance, can be set and maintained
accurately to ensure the safety of the patient
and the user; and
(b) as far as possible, the accidental release of
dangerous levels of energy or of the substance
is prevented.
(3) The device must be fitted with a means of indicating
or, if appropriate, preventing inadequacies in the rate
and amount of energy, or of the substance,
administered that might cause danger to the patient,
the user or any other person.
(4) The functions of each control and indicator on the
device must be clearly specified on the device.
(5) If the instructions for the operation of the device, or
the operating or adjustment parameters for the
device, are displayed by means of a visual system
incorporated into the device, the instructions or
parameters must be able to be understood by the
user and, if appropriate, the patient.

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
12.13
standard or other
Active implantable medical devices
procedure applied
(1) An active implantable medical device must
incorporate, display, emit or exhibit a code or unique
characteristic that can be used to identify:
(a) the type of device; and
(b) the manufacturer of the device; and

(c) the year of manufacture of the device.

(2) The code or unique characteristic must be able to be
read without the need for surgery to the person in
whom the device is implanted.

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EP 13: Information to be provided with medical devices

Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
13 Information to be provided with medical procedure applied
devices
13.1 Information to be provided with medical devices—
general
(1) The following information must be provided with a
medical device:
(a) information identifying the device;
(b) information identifying the manufacturer of the
device;
(c) information explaining how to use the device
safely
having regard to the training and knowledge of
potential users of the device.
(2) In particular
(a) the information required by clause 13.3 must be
provided with a medical device; and
(b) if instructions for use of the device are required
under subclause 13.4, the information
mentioned in subclause 13.4(3) must be
provided in those instructions.
(3) The information:
(a) must be provided in English; and
(b) may also be provided in any other language.
(4) The format, content and location of the information
must be appropriate for the device and its intended
purpose.
(5) Any number, letter, symbol, or letter or number in a
symbol, used in the information must be legible and

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
at least 1 millimetre high. procedure applied
(6) If a symbol or identification colour that is not included
in a medical device standard is used in the
information provided with the device, or in the
instructions for use of the device, the meaning of the
symbol or identification colour must be explained in
the information provided with the device or the
instructions for use of the device.
13.2 Information to be provided with medical devices-
location
(1) Unless it is impracticable or inappropriate to do so,
the information required to be provided with a
medical device must be provided on the device itself.
(2) If it is not practicable to comply with subclause (1) in
relation to the provision of the information, the
information must be provided:
(a) on the packaging used for the device; or
(b) in the case of devices that are packaged
together because individual packaging of the
devices for supply is not practicable—on the
outer packaging used for the devices.
(3) If it is not practicable to comply with subclause (1) or
(2) in relation to the provision of the information
required under subregulation 10.2(1) or clause 13.3:
(a) for a medical device that is not software—the
information must be provided on a leaflet
supplied with the device; or
(b) for a medical device that is software—the
information must be provided on a leaflet
supplied with the device or the information must
be provided electronically.
(4) If it is not practicable to comply with subclause (1) or
(2) in relation to the provision of the information

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
required under clause 13.4, the information must be procedure applied
provided in a printed document or using other
appropriate media.
13.3 Information to be provided with medical devices-
particular requirements
The information mentioned in the following table must be
provided with a medical device.
Item Information to be provided
1 The manufacturer’s name, or trading name, and
address
2 The intended purpose of the device, the intended
user of the device, and the kind of patient on
whom the device is intended to be used (if this
information is not obvious)
3 Sufficient information to enable a user to identify
the device, or if relevant, the contents of
packaging
4 Any particular handling or storage requirements
applying to the device
5 Any warnings, restrictions, or precautions that
should be taken, in relation to use of the device
6 Any special operating instructions for the use of
the device
7 If applicable, an indication that the device is
intended for a single use only
8 If applicable, an indication that the device has
been custom-made for a particular individual or
health professional and is intended for use only by
that individual or health professional
9 If applicable, an indication that:
(a) if the device is a medical device other
than an IVD medical device—the device

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
is intended for pre-market clinical
investigation; or
(b) if the device is an IVD medical device—
the device is intended for performance
evaluation only
10 For a sterile device, the word ‘STERILE’ and
information about the method that was used to
sterilise the device
11 The batch code, lot number or serial number of
the device
12 If applicable, a statement of the date (expressed
in a way that clearly identifies the month and year)
up to when the device can be safely used
13 If the information provided with the device does
not include the information mentioned in item 12
—a statement of the date of manufacture of the
device (this may be included in the batch code, lot
number or serial number of the device, provided
the date is clearly identifiable)
14 If applicable, the words ‘for export only’
Note: In addition to the information mentioned in the above
table, regulation 10.21 requires certain information to be
provided with a medical device.
13.4 Instructions for use
(1) Instructions for the use of a medical device must be
provided with the device.
(2) However, instructions for the use of a medical device
need not be provided with the device, or may be
abbreviated, if:
(a) the device is a Class I medical device, a Class
IIa medical device or a Class 1 IVD medical
1
Therapeutic Goods (Medical Devices) Regulations 2002, 10.2 “Information about sponsor” ([Link]/about-tga/legislation/legislation-and-legislative-
instruments#acts)

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
device; and
(b) the device can be used safely for its intended
purpose without instructions.
(3) Instructions for the use of a medical device must
include information mentioned in the following table
that is applicable to the device.
Item Information to be provided
1 The manufacturer’s name, or trading name, and
address
2 The intended purpose of the device, the intended
user of the device, and the kind of patient on
whom the device is intended to be used
3 Information about any risk arising because of
other equipment likely to be present when the
device is being used for its intended purpose (for
example, electrical interference from
electro-surgical devices or magnetic field
interference from magnetic resonance imaging
devices).
4 Information about the intended performance of
the device and any undesirable side effects
caused by use of the device.
5 Any contra-indications, warnings, restrictions, or
precautions that may apply in relation to use of
the device.
6 Sufficient information to enable a user to identify
the device, or if relevant, the contents of
packaging.
7 Any particular handling or storage requirements
applying to the device.
8 If applicable, an indication that the device is
intended for a single use only.

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
9 If applicable, an indication that the device has
been custom-made for a particular individual or
health professional and is intended for use only
by that individual or health professional.
10 If applicable, an indication that:
(a) if the device is a medical device other
than an IVD medical device—the device
is intended for pre-market clinical
investigation; or
(b) if the device is an IVD medical device—
the device is intended for performance
evaluation only.
11 For a sterile device, the word ‘STERILE’ and
information about the method that was used to
sterilise the device.
12 For a device that is intended by the manufacturer
to be supplied in a sterile state:
(a) an indication that the device is sterile;
and
(b) information about what to do if sterile
packaging is damaged; and
(c) if appropriate, instructions for re-
sterilisation of the device.
13 For a medical device that is intended by the
manufacturer to be sterilised before use—
instructions for cleaning and sterilising the device
which, if followed, will ensure that the device
continues to comply with the applicable provisions
of the Essential Principles.
14 Any special operating instructions for the use of
the device.
15 Information to enable the user to verify whether
the device is properly installed and whether it can

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
be operated safely and correctly, including details procedure applied
of calibration (if any) needed to ensure that the
device operates properly and safely during its
intended life.
16 Information about the nature and frequency of
regular and preventative maintenance of the
device, including information about the
replacement of consumable components of the
device during its intended life.
17 Information about any treatment or handling
needed before the device can be used.
18 For a device that is intended by the manufacturer
to be installed with, or connected to, another
medical device or other equipment so that the
device can operate as required for its intended
purpose—sufficient information about the device
to enable the user to identify the appropriate other
medical device or equipment that will ensure a
safe combination.
19 For an implantable medical device—information
about any risks associated with its implantation.
20 For a reusable device:
(a) information about the appropriate
processes to allow reuse of the device
(including information about cleaning,
disinfection, packaging and, if
appropriate, re-sterilisation of the device);
and
(b) an indication of the number of times the
device may be safely reused.
21 For a medical device that is intended by the
manufacturer to emit radiation for medical
purposes—details of the nature, type, intensity,
and distribution of the radiation emitted.

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
22 Information about precautions that should be
taken by a patient and the user if the performance
of the device changes.
23 Information about precautions that should be
taken by a patient and the user if it is reasonably
foreseeable that use of the device will result in the
patient or user being exposed to adverse
environmental conditions.
24 Adequate information about any medicinal
product that the device is designed to administer,
including any limitations on the substances that
may be administered using the device.
25 Information about any medicine (including any
stable derivative of human blood or blood
plasma) that is incorporated, or is intended to be
incorporated, into the device as an integral part of
the device.
25A For a medical device to which clause 5.5 of
Schedule 2 applies (other than an IVD medical
device), information to the effect that the device
contains or incorporates any of the following:
(a) non-viable tissues, or cells, of animal
origin;
(b) derivatives of tissues or cells covered by
paragraph.
26 Information about precautions that should be
taken by a patient and the user if there are special
or unusual risks associated with the disposal of
the device.
27 Information about the degree of accuracy claimed
if the device has a measuring function.
28 Information about any particular facilities required
for use of the device or any particular training or
qualifications required by the user of the device.

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
29 For an IVD medical device, information (including, procedure applied
to the extent practicable, drawings and diagrams)
about the following:
(a) the scientific principle (the ‘test principle’)
on which the performance of the IVD
medical device relies;
(b) specimen type, collection, handling, and
preparation;
(c) reagent description and any limitations
(for example, use with a dedicated
instrument only);
(d) assay procedure including calculations
and interpretation of results;
(e) interfering substances and their effect on
the performance of the assay;
(f) analytical performance characteristics,
such as sensitivity, specificity, accuracy
and precision;
(g) clinical performance characteristics, such
as sensitivity and specificity;
(h) reference intervals, if appropriate;
(i) any precautions to be taken in relation to
substances or materials that present a
risk of infection.
30 For an adaptable medical device, instructions for
assembling or adapting the device which, if
followed, will ensure that the device continues to
comply with the applicable provisions of the
Essential Principles.
31 For a medical device production system,
instructions for the process to be followed in
producing the medical device the system is
intended to produce which, if followed, will ensure

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
that the device so produced will comply with the procedure applied
applicable provisions of the Essential Principles.
13.5 UDI medical devices—UDI device identifier and
UDI production identifier
(1) For a UDI medical device, the UDI device identifier, and the
UDI production identifier, of the UDI medical device must
be provided with the UDI medical device in accordance
with this clause.
General Rule
(2) Subject to this clause:
(a) subject to paragraphs (b) and (c), each identifier, in
human-readable form and machine-readable form,
must be provided on the UDI medical device itself; or
(b) subject to paragraph (c), if it is impracticable or
inappropriate to comply with paragraph (a), each
identifier, in human-readable form and
machine-readable form:
(i) must be provided on the packaging used for the
UDI medical device, unless subparagraph (ii)
applies; or
(ii) if the UDI medical device is packaged together
with other such UDI medical devices because
individual packaging of the UDI medical devices
for supply is not practicable—must be provided
on the outer packaging used for the UDI medical
devices; or
(c) if it is impracticable or inappropriate to comply with
paragraphs (a) and (b)—each identifier, in
human-readable form and machine-readable form:
(i) if the UDI medical device is not software—must
be provided on a leaflet supplied with the UDI
medical device; or
(ii) if the UDI medical device is software—must be
provided on a leaflet supplied with the UDI
medical device or must be provided electronically.

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 Part 2. Design and construction Applicable Not applicable Medical Devices / IVD Evidence of compliance
standard or other
UDI medical device to which clause 13C.5 applies procedure applied
(3) For a UDI medical device to which clause 13C.5 applies,
on and after the direct marking start day for the UDI
medical device, subclause (2) of this clause ceases to
apply in relation to the UDI medical device. Instead:
(a) subject to paragraph (b), each identifier, in
human-readable form and machine-readable form:
(i) must be provided on the packaging used for the
UDI medical device, unless subparagraph (ii)
applies; or
(ii) if the UDI medical device is packaged together
with other such UDI medical devices because
individual packaging of the UDI medical devices
for supply is not practicable—must be provided
on the outer packaging used for the UDI medical
devices; or
(b) if it is impracticable or inappropriate to comply with
paragraph (a)—each identifier, in human-readable
form and machine-readable form, must be provided on
a leaflet supplied with the UDI medical device.
Qualification for UDI medical device intended by
manufacturer to be supplied at retail premises
(4) For a UDI medical device that is intended by the
manufacturer to be supplied at retail premises, the UDI
production identifier of the UDI medical device, in
machine-readable form, is not required to be provided with
the UDI medical device.
13.6 UDI medical devices—medical device packaging
identifier
(1) If a type of packaging is used for a UDI medical device, the
medical device packaging identifier of that packaging must
be provided with the UDI medical device.
(2) That identifier, in human-readable form and
machine-readable form, must be provided on the
packaging of the UDI medical device.

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Medical Devices Essential Principles Checklist
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EP 13A: Patient information about implantable medical devices or active implantable medical
devices to be made available

Applicable Not applicable Medical Devices/IVD Evidence of compliance

Part 2. Design and construction standard or other
procedure applied
13A Patient information about implantable medical
devices or active implantable medical devices
to be made available
13A.1 Scope of clauses 13A.2 to 13A.4
(1) Clauses 13A.2 to 13A.4 apply to a medical device that
is:
(a) an implantable medical device or an active
implantable medical device; and
(b) not a suture, staple, dental filling, dental brace,
tooth crown, screw, wedge, plate, wire, pin, clip,
connector, or similar article; and
(i) not intended by the manufacturer to be for
export only; and
(c) not a medical device to which subclause (2)
applies.
(2) This subclause applies to a medical device if:
(a) the medical device is intended by the
manufacturer to be wholly, or mostly, absorbed by
a patient’s body within 6 months of being
implanted; and
(b) the medical device is:
(i) for use as a filler; or
(ii) for haemostasis; or
(iii) for tissue approximation; or

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 2. Design and construction standard or other
procedure applied
(iv) for the fixation of other medical devices within
tissue; or
(v) a similar medical device to a medical device
covered by subparagraph (i), (ii), (iii) or (iv).
13A.2 Patient implant cards etc. for implantable devices
(1) Either:
(a) a card (a patient implant card) that:
(i) in any case—includes the information covered by
subclause (2) and that satisfies clause 13A.4; and
(ii) for a UDI medical device—includes the UDI device
identifier, and the UDI production identifier, of the
UDI medical device (where each identifier is in
human-readable form and machine-readable form);
must be made available for provision to the patient
concerned; or
(b) the following:
(i) in any case—information covered by subclause (2)
and that satisfies clause 13A.4;
(ii) for a UDI medical device—the UDI device identifier,
and the UDI production identifier, of the UDI medical
device (where each identifier is in human-readable
form and machine-readable form);
must be made available electronically and in a way that
is readily accessible by the patient concerned.
(2) The information covered by this subclause is the
information in the following table.
Item Information to be provided
1 (a) the name of the device; and
(b) the model of the device; and
(c) the batch code, lot number or serial number of
the device
2 The manufacturer’s name, address, and

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 2. Design and construction standard or other
procedure applied
website
13A.3 Patient information leaflets etc. for implantable devices
(1) Either:
(a) a leaflet (a patient information leaflet) that
includes the information covered by
subclauses (2) and (3) and that satisfies
subclause (4) and clause 13A.4 must be made
available for provision to the patient concerned; or
(b) information covered by subclauses (2) and (3) that
is in electronic form and that satisfies
subclause (4) and clause 13A.4 must be made
available in a way that is readily accessible by the
patient concerned.
(2) The information covered by this subclause is the
following information:
(a) information identifying the device, or the kind of
device;
(b) the intended purpose of the device;
(c) information explaining how to use the device
safely;
(d) other information about the device that the
manufacturer considers would be useful for
patients.
(3) The information covered by this subclause is the
information in the following table.
Item Information to be provided
1 (a) the name of the device; and
(b) the model of the device
2 (a) the intended purpose of the device; and

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 2. Design and construction standard or other
procedure applied
(b) the kind of patient on whom the device is
intended to be used
3 Any special operating instructions for the use of
the device
4 (a) the intended performance of the device;
and
(b) any undesirable side effects that could be
caused by use of the device.
5 Any residual risks that could arise due to any
shortcomings of the protection measures adopted
as mentioned in subclause 2(2).
6 (a) warnings about risks that could arise
from the interaction of the device with
other equipment; and
(b) precautions and other measures that,
because of those risks, should be taken
by the patient or a health professional
(i) Example 1: The risk of electrical
interference from electro-surgical
devices.
(ii) Example 2: The risk of magnetic field
interference from magnetic
resonance imaging devices.
7 (a) the nature and frequency of regular or
preventative examination, monitoring or
maintenance of the device that should be
undertaken; and
(b) symptoms that could indicate that the
device is malfunctioning; and
(c) precautions and other measures that
should be taken by the patient if the
performance of the device changes or

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 2. Design and construction standard or other
procedure applied
the patient experiences any of the
symptoms mentioned in paragraph (b);
and
(d) the expected device lifetime; and
(e) anything that could shorten or lengthen
the device lifetime; and
(f) precautions and other measures that
should be taken at, or near, the end of
the expected device lifetime; and
(g) other circumstances in which the patient
should contact a health professional in
relation to the operation of the device
8 (a) the materials and substances included in
the device; and
(b) any manufacturing residuals that could
pose a risk to the patient
9 (a) a notice that any serious incident that
occurs in relation to the device should be
reported to the manufacturer and to the
Therapeutic Goods Administration; and
(b) the address of the Therapeutic Goods
Administration’s website [Link].
(4) The information covered by subclauses (2) and (3)
must be written in a way that is readily understood by
patients.

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
Part 2. Design and construction standard or other
procedure applied
13A.4 General requirements for information to be made
available for patients
(1) The information covered by subclause 13A.2(2) or
13A.3(2) or (3):
(a) must be included in English; and
(b) may also be included in any other language.
Note: The information may also include diagrams or drawings.
(2) Any number, letter or symbol, or letter or number in a
symbol, that is part of the information covered by
subclause 13A.2(2) or 13A.3(2) or (3) must be:
(a) legible; and
(b) if the number, letter or symbol, or letter or number
in a symbol, is included in a patient implant card or
patient information leaflet—at least 1 millimetre
high.

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EP 13B: Software (version numbers and build numbers)

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
13B Software (version numbers and build numbers) procedure applied
13B (1) For a medical device that is software, or that
incorporates software, the current version number and
current build number of the software must be
accessible by, and identifiable to, users of the device.
(2) The current version number and current build number
of the software:
(a) must be in English; and
(b) may also be in any other language.

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EP 13C: Rules for UDI medical devices
Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
13C Identifiers relating to UDI medical devices procedure applied
(1) For UDI medical devices that are a type of model, the UDI
13C.1 device identifier of those medical devices must have been
issued by a UDI issuing agency.
(2) For UDI medical devices that are a type of model, the UDI
production identifier of those medical devices must have
been allocated by, or on behalf of, the manufacturer in
accordance with any applicable requirements of the UDI
issuing agency that issued the UDI device identifier of those
medical devices.
(3) If a type of packaging is used for UDI medical devices that
are a type of model, the medical device packaging identifier
of that packaging must have been issued by a UDI issuing
agency.
(4) In relation to UDI medical devices that are a type of model,
the identifiers covered by subclauses (1) and (3) must have
been issued by the same UDI issuing agency.
13C.2 Inclusion of identifiers in the Australian Unique Device
Identification Database
Inclusion of UDI device identifiers
(1) For UDI medical devices that are a type of model:
(a) the UDI device identifier of those medical devices must
be included in the Australian Unique Device
Identification Database; and
(b) the name of the UDI issuing agency that issued the
UDI device identifier must be included in that database.
Note: Subclause (5) deals with the circumstances in which there is a
different type of model of UDI medical devices. The UDI device
identifier of the UDI medical devices of the different type of model
would then need to be included in that database.
Inclusion of medical device package identifiers

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
(2) If a type of packaging is used for UDI medical devices that procedure applied
are a type of model, the medical device packaging identifier
of that packaging must be included in the Australian Unique
Device Identification Database.
Timing of inclusion of information
(3) The information covered by subclause (1), for UDI medical
devices that are a type of model, must be included in the
Australian Unique Device Identification Database before the
end of the period of 30 days beginning on the first day, that
is on or after the general start day for the UDI medical
devices, on which the UDI medical devices are supplied for
use in Australia.
(4) The information covered by subclause (2), for a type of
packaging that is used for UDI medical devices that are a
type of model, must be included in the Australian Unique
Device Identification Database before the end of the period
of 30 days beginning on the first day, that is on or after the
general start day for the UDI medical devices, on which the
UDI medical devices are supplied for use in Australia with
that type of packaging.
Different models of medical devices
(5) Subject to subclause (6), if a change (a relevant change)
of the following kind occurs to or in relation to UDI medical
devices that are a type of model, those medical devices, as
affected by that change, are taken to be a different type of
model:
(a) if the medical devices are not labelled as being for a
single use only—the medical devices are labelled as
being for a single use only;
(b) the labels for the medical devices, or information
provided with the medical devices, state that the
medical devices contain latex;
(c) a change to the magnetic resonance imaging safety
status of the medical devices;

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
(d) the labels for the medical devices, or information procedure applied
provided with the medical devices, state that the
medical devices are packaged in a sterile state;
(e) the labels for the medical devices, or information
provided with the medical devices, state that the
medical devices must be sterilised before use;
(f) a change to the clinical size of the medical devices;
(g) if the labels for the medical devices, or information
provided with the medical devices, refer to a
recommended number of reuses of the medical
devices—a reduction in that recommended number of
reuses;
(h) a change to the brand name of the medical devices;
(i) a change to the model number or version number of
the medical devices;
(j) a change to the quantity of the medical devices
provided in a package;
(k) if the medical devices are software—a change to the
features of the software (including the addition of a new
feature or a change to an existing feature) that results
in a change to the safety, performance or intended
purpose of the medical devices.
Note: The medical devices, before the change, remain a type of
model.
(6) If 2 or more relevant changes occur to or in relation to UDI
medical devices that are a type of model as part of the same
change in production of those medical devices, those
medical devices, as affected by the 2 or more relevant
changes, are taken to be a different type of model.
(7) Subclause (5) does not limit the circumstances in which
there may be a different type of model of UDI medical
devices.
13C.3 Inclusion of other information in the Australian Unique

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
Device Identification Database procedure applied
(1) For a UDI medical device, the following information must be
included in the Australian Unique Device Identification
Database:
(a) the identification number allocated to the manufacturer
by the Therapeutic Goods Administration;
(b) the manufacturer’s name or trading name;
(c) the brand name of the device;
(d) the device number in relation to the device;
(e) the model number or version number of the device;
(f) any additional identifiers that are associated with the
device;
(g) any particular handling or storage requirements
applying to the device;
(h) any warnings, restrictions, or precautions that should
be taken, in relation to use of the device;
(i) any special operating instructions for the use of the
device;
(j) the following:
(i) whether or not the device is intended for a single
use only;
(ii) if the device is not intended for a single use only—
any restrictions on the number of times the device
can be used;
(k) if applicable, information about the method to sterilise
the device;
(l) whether or not a batch code, lot number or serial
number is to be provided with the device;
(m) whether or not the date of manufacture of the device, or
the expiry date of the device, is to be provided with the
device;
(n) if the device is intended to be used in connection with

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
blood, blood components or blood products—whether procedure applied
or not a donation identification number is able to be
provided with the device;
(o) whether or not the device is, or incorporates, software;
(p) whether or not the device is a type of kit;
(q) if the device is intended to be packaged together with
UDI medical devices of the same model—the number
of medical devices intended to be included in the base
package.
Note: For the definition of device number, in relation to a medical
device, see subsection 3(1) of the Act.
(2) If the clinical size type of a UDI medical device is included in
the Australian Unique Device Identification Database, then
the clinical size value, and the clinical size unit of measure,
of the UDI medical device must also be included in that
database.
(3) The information required to be included in that database by
subclause (1) or (2) must be included in that database
before the end of the period of 30 days beginning on the first
day, that is on or after the general start day for the UDI
medical device, on which the UDI medical device is supplied
for use in Australia.
13C.4 Information in the Australian Unique Device
Identification Database to be accurate and up to date
Information included in the Australian Unique Device
Identification Database must be accurate and up to
date.
13C.5 UDI device identifier and UDI production identifier to be
directly marked on UDI medical device
(1) For UDI medical devices that are a type of model and are
intended by the manufacturer to be reprocessed between
use on different patients, the UDI device identifier, and the
UDI production identifier, of those medical devices:
(a) must be directly marked on those medical devices by

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 Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
the manufacturer; and procedure applied
(b) must be directly marked as follows:
(i) in human-readable form and machine-readable
form, unless subparagraph (ii) applies;
(ii) if it is impracticable or inappropriate for direct
marking in both forms—in human-readable form
or machine-readable form.
(2) Subclause (1) does not apply in relation to UDI medical
devices that are a type of model if:
(a) those medical devices have been manufactured before
the direct marking start day for those medical devices;
or
(b) those medical devices are implantable medical
devices; or
(c) the direct marking of the UDI device identifier, and the
UDI production identifier, of those medical devices on
those medical devices is likely to affect the safety,
performance or effectiveness of those medical devices;
or
(d) it would be impracticable for the manufacturer to
directly mark the UDI device identifier, and the UDI
production identifier, of those medical devices on those
medical devices.

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EP 14: Clinical evidence

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
14 Clinical evidence procedure applied

14 Every medical device requires clinical evidence,

appropriate for the use and classification of the device,
demonstrating that the device complies with the applicable
provisions of the Essential Principles.
Note: See regulation 3.11 and the clinical evaluation procedures.

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EP 15: Principles applying to IVD medical devices only

Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
15 Principles applying to IVD medical devices procedure applied
only
15 (1) An IVD medical device must be designed and
manufactured in a way in which the analytical and
clinical characteristics support the intended use, based
on appropriate scientific and technical methods.
(2) An IVD medical device must be designed in a way that
addresses accuracy, precision, sensitivity, specificity,
stability, control of known relevant interference and
measurement of uncertainty, as appropriate.
(3) If performance of an IVD medical device depends in
whole or part on the use of calibrators or control
materials, the traceability of values assigned to the
calibrators or control material must be assured through
a quality management system.
(4) An IVD medical device must, to the extent reasonably
practicable, include provision for the user to verify, at
the time of use, that the device will perform as intended
by the manufacturer.
(5) An IVD medical device for self-testing must be
designed and manufactured so that it performs
appropriately for its intended purpose, taking into
account the skills and the means available to users
and the influence resulting from variation that can
reasonably be anticipated in the user’s technique and
environment.
(6) The information and instructions provided by the
manufacturer of an IVD medical device for self-testing
must be easy for the user to understand and apply.

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 Part 2. Design and construction Applicable Not applicable Medical Devices/IVD Evidence of compliance
standard or other
(7) An IVD medical device for self-testing must be
designed and manufactured in a way that reduces, to
the extent practicable, the risk of error in the use of the
device, the handling of the sample and the
interpretation of results.

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