Essential principles of safety and
Essential requirements - European MDD Annex I
performance - GHTF.SG1.N020R5
I. GENERAL REQUIREMENTS
1. The devices must be designed and
manufactured in such a way that, when used
under the conditions and for the purposes
intended, and, where applicable, by virtue of the
technical knowledge, experience, education or
training of intended users, they will not
compromise the clinical condition or the safety of
patients, or the safety and health of users or,
where applicable, other persons,
provided that any risks which may be associated
with their use constitute acceptable risks when
weighed against the benefits to the patient and
are compatible with a high level of protection of
health and safety.
2. The solutions adopted by the manufacturer for
the design and construction of the devices must
conform to safety principles, taking account of
the generally acknowledged state of the art.
In selecting the most appropriate solutions, the In selecting the most appropriate solutions, the
manufacturer must apply the following principles manufacturer must apply the following principles in
in the following order: the following order:
- identify hazards and the associated risks
arising from the intended use and foreseeable
misuse,
- eliminate or reduce risks as far as possible
(inherently safe design and construction),
Safety and Effectiveness Requirements -
Health Canada Medical Devices Regulations
I. GENERAL REQUIREMENTS
1. The devices must be designed and manufactured
11. A medical device shall not, when used for the
in such a way that, when used under the conditions
medical conditions, purposes or uses for which it
and for the purposes intended, they will not
is manufactured, sold or represented, adversely
compromise the clinical condition or the safety of
affect the health or safety of a patient, user or
patients, or the safety and health of users or, where
other person,
applicable, other persons,
except to the extent that a possible adverse effect
provided that any risks which may be associated with
of the device constitutes an acceptable risk when
their use constitute acceptable risks when weighed
weighed against the benefits to the patient and the
against the benefits to the patient and are compatible
risk is compatible with a high level of protection of
with a high level of protection of health and safety.
health and safety.
2. The solutions adopted by the manufacturer for the 10. A medical device shall be designed and
design and construction of the devices must conform manufactured to be safe, and to this end the
to safety principles, taking account of the generally manufacturer shall, in particular, take reasonable
acknowledged state of the art. measures to
(a) identify the risks inherent in the device;
(b)   if the risks can be eliminated, eliminate them; (b) second, eliminate, or reduce, these risks as far as
- eliminate or reduce risks as far as possible
(c)   if the risks cannot be eliminated, (i) reduce the possible by adopting a policy of inherently safe
(inherently safe design and construction),
risks to the extent possible;
Page 1 of 24
Essential Principles - Australian Therapeutic
Goods (Medical Devices) Regulations 2001
I. GENERAL PRINCIPLES
1. Use of medical devices not to compromise
health and safety - A medical device is to be
designed and manufactured in such 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 or 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.
2. Design and construction of medical devices to
conform with safety principles (1) The solutions
adopted by the manufacturer for the design and
construction of a medical device must conform to
safety principles, having regard to the generally
acknowledged state of the art.
(2) Without limiting sub-clause (1), in selecting
appropriate solutions for the design and construction
of a medical device so as to minimize any risks
associated with the use of the device, the
manufacturer must:
(a) first, identify hazards and the associated risks
arising from the use of the device for its intended
purpose, and foreseeable misuse of the device; and
design and construction; and

- where appropriate take adequate protection
measures including alarms if necessary, in
relation to risks that cannot be eliminated
- inform users of the residual risks due to any - inform users of the residual risks due to any
shortcomings of the protection methods adopted shortcomings of the protection methods adopted
3. The devices must achieve the performances
intended by the manufacturer and
be designed, manufactured and packaged in
such a way that they are suitable for one or more
of the functions within the scope of the definition
of a medical device applicable in each
jurisdiction.
4. The characteristics and performances referred
to in sections 1, 2 and 3 must not be adversely
affected to such a degree that the clinical
conditions and safety of the patients and, where
applicable, of other persons are compromised
during the lifetime of the device as indicated by
the manufacturer,
when the device is subjected to the stresses when the device is subjected to the stresses which
which can occur during normal conditions of use can occur during normal conditions of use.
and has been properly maintained in accordance
with the manufacturer’s instructions.
- where appropriate take adequate protection
(ii) provide for protection appropriate to those
measures including alarms if necessary, in relation to
risks, including the provision of alarms, and
risks that cannot be eliminated,
3. The devices must achieve the performances
intended by the manufacturer and
be designed, manufactured and packaged in such a
way that they are suitable for one or more of the
functions referred to in Article 1(2) (a), as specified by
the manufacturer.
4. The characteristics and performances referred to in
sections 1, 2 and 3 must not be adversely affected to
such a degree that the clinical conditions and safety
of the patients and, where applicable, of other
persons are compromised during the lifetime of the
device as indicated by the manufacturer,
Page 2 of 24
(iii) provide, with the device, information relative to
the risks that remain; and
(d) minimize the hazard from potential failures
during the projected useful life of the device.
12. A medical device shall perform as intended by
the manufacturer and shall be effective for the
medical conditions, purposes and uses for which it
is manufactured, sold or represented.
13. During the projected useful life of a medical
device, its characteristics and performance shall
not deteriorate under normal use to such a degree
that the health or safety of a patient, user or other
person is adversely affected.
14. The characteristics and performance of a
medical device shall not be adversely affected by
transport or conditions of storage, taking into
account the manufacturer’s instructions and
information for transport and storage.
(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. Medical devices to be suitable for intended
purpose - A medical device must: (a) be capable of
performing in the way intended by the manufacturer;
and
(b) be designed, manufactured 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 the Act.
4. Long-term safety - A medical device must be
designed and manufactured in a way that ensures
that the characteristics and performances mentioned
in clauses 1, 2 and 3 are not adversely affected if: (a)
a device is used within the period, indicated by the
manufacturer, in which the device can be safely
used;
(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;
 5. Medical devices not adversely affected by
5. The devices must be designed, manufactured transport and storage - A medical device must
5. The devices must be designed, manufactured and
and packed in such a way that their be designed, manufactured and packed in a way
packed in such a way that their characteristics and
characteristics and performances during their that ensures that the characteristics and
performances during their intended use will not be
intended use will not be adversely affected performance of the device when it is being used
adversely affected during transport and storage taking
during transport and storage taking account of for its intended purpose will not be adversely
account of the instructions and information provided
the instructions and information provided by the affected during transport and storage that is
by the manufacturer.
manufacturer. carried out taking account of the instructions and
information provided by the manufacturer.

6. Benefits of medical devices to outweigh any

6. The benefits must be determined to outweigh 6. Any undesirable side effect must constitute an side effects - The benefits to be gained from the
any undesirable side effects for the acceptable risk when weighed against the use of a medical device for the performance
performances intended. performances intended. intended by the manufacturer must outweigh any
undesirable side effects arising from its use.

II. REQUIREMENTS REGARDING DESIGN II. REQUIREMENTS REGARDING DESIGN AND II. PRINCIPLES ABOUT DESIGN AND
AND CONSTRUCTION CONSTRUCTION CONSTRUCTION

7. Chemical, physical and biological properties 7. Chemical, physical and biological properties 7. Chemical, physical and biological properties

7.1 The devices must be designed and

7.1 The devices must be designed and manufactured 7.1 Choice of materials - In ensuring that the
manufactured in such a way as to guarantee the
in such a way as to guarantee the characteristics and requirements of Part I are met in relation to a medical
characteristics and performances referred to in
performances referred to in Section I on the "General device, particular attention must be given to the
Section I on the "General requirements".
requirements". Particular attention must be paid to: following matters:
Particular attention must be paid to:

- the choice of materials used, particularly as (a) the choice of materials used in the devices,
- the choice of materials used, particularly as regards
regards toxicity and, where appropriate, having regard, if appropriate, to: (i) toxicity and
toxicity and, where appropriate, flammability,
flammability, flammability; and

15. Reasonable measures shall be taken to

ensure that every material used in the
the compatibility between the materials used
the compatibility between the materials used and manufacture of a medical device shall be (b) the compatibility between the materials used and
and biological tissues, cells and body fluids,
biological tissues, cells and body fluids, taking compatible with every other material with which it biological tissues, cells and body fluids, having
taking account of the intended purpose of the
account of the intended purpose of the device. interacts and with material that may come into regard to the intended purpose of the device.
device
contact with it in normal use, and shall not pose
any undue risk to a patient, user or other person.

the choice of materials used should reflect,

(ii) any other mechanical and physical properties of
where appropriate, matters such as hardness,
the materials used;
wear and fatigue strength.

Page 3 of 24

7.2 The devices must be designed,
manufactured and packed in such a way as to
minimize the risk posed by contaminants and
residues to the persons involved in the transport,
storage and use of the devices and to the
patients, taking account of the intended purpose
of the product.
Particular attention must be paid to the tissues
exposed and to the duration and frequency of
the exposure.
7.3 The devices must be designed and
manufactured in such a way that they can be
used safely with the materials, substances and
gases with which they enter into contact during
their normal use or during routine procedures
if the devices are intended to administer
medicinal products they must be designed and
manufactured in such a way as to be compatible
with the medicinal products concerned according
to the provisions and restrictions governing
these products and that their performance is
maintained in accordance with the intended use.
7.4 Where a device incorporates, as an integral
part, a substance which, if used separately, may
be considered to be a medicinal product as
defined in the relevant legislation that applies
within that jurisdiction and which is liable to act
upon the body with action ancillary to that of the
device, the safety, quality and usefulness of the
substance must be verified, taking account of the
intended purpose of the device.
7.2 Minimization of risks associated with
7.2 The devices must be designed, manufactured and contaminants and residues - (1) A medical device
16. The design, manufacture and packaging of a
packed in such a way as to minimize the risk posed must be designed, manufactured and packed in a
medical device shall minimize any risk to a patient,
by contaminants and residues to the persons involved way that ensures that any risks associated with
user or other person from reasonably foreseeable
in the transport, storage and use of the devices and to contaminants and residues that may affect a person
hazards, including - (b) presence of a contaminant
the patients, taking account of the intended purpose who is involved in transporting, storing or using the
or chemical or microbial residue
of the product. device, or a patient, are minimized, having regard to
the intended purpose of the device.
(2) In minimizing the risks, particular consideration
Particular attention must be paid to the tissues
must be given to the likely duration and frequency of
exposed and to the duration and frequency of the
any tissue exposure associated with the
exposure.
transportation, storage or use of the device.
7.3 Ability to be used safely with materials etc. (1) A
7.3 The devices must be designed and manufactured
medical device must be designed and manufactured
in such a way that they can be used safely with the
in a way that ensures that the device can be used
materials, substances and gases with which they
safely with any material, substance or gas with which
enter into contact during their normal use or during
the device may come into contact during normal use
routine procedures;
or use in routine procedures.
if the devices are intended to administer medicinal
(2) If the device is intended to be used to administer
products they must be designed and manufactured in
medicine, it must be designed and manufactured in a
such a way as to be compatible with the medicinal
way that ensures that the device: (a) is compatible
products concerned according to the provisions and
with the provisions and restrictions applying to the
restrictions governing these products and that their
medicine to be administered; and (b) allows the
performance is maintained in accordance with the
medicine to perform as intended.
intended use.
7.4 Where a device incorporates, as an integral part, 7.4 Verification of incorporated substance - If a
a substance which, if used separately, may be medical device incorporates, as an integral part, a
considered to be a medicinal product as defined in substance that, if used separately, might be
Article 1 of Directive 65/65/EEC and which is liable to considered to be a medicine, that is intended to act
act upon the body with action ancillary to that of the on a patient in a way that is ancillary to the device:
device, the safety, quality and usefulness of the (a) the safety and quality of the substance must be
substance must be verified, taking account of the verified in accordance with the requirements for
intended purpose of the device, by analogy with the medicines; and (b) the ancillary action of the
appropriate methods specified in Directive substance must be verified having regard to the
75/318/EEC. intended purpose of the device.
Page 4 of 24
7.5 The devices must be designed and
manufactured in such a way as to reduce to a
minimum the risks posed by substances that
may leach from the device.
7.6 Devices must be designed and manufactured
in such a way as to reduce as much as possible,
risks posed by the unintentional ingress or
egress of substances into or from the device
taking into account the device and the nature of
the environment in which it is intended to be
used.
8. Infection and microbial contamination
8.1 The devices and manufacturing processes
must be designed in such a way as to eliminate
or reduce as far as possible the risk of infection
to the patient, user and, where applicable, other
persons.
The design must allow easy handling and, where The design must allow easy handling and, where
necessary, minimize contamination of the device necessary, minimize contamination of the device by
by the patient or vice versa during use. the patient or vice versa during use.
8.2.1 Tissues of non-human origin as far as
considered a medical device, should originate
from animals that have been subjected to
veterinary controls and surveillance adapted to
the intended use of the tissues.
National Regulations may require that that the
manufacturer and/or the Competent/Regulatory
Authority should retain information on the
geographical origin of the animals.
7.5 Minimization of risks associated with leaching of
substances
7.5 The devices must be designed and manufactured 7.6 Minimization of risks associated with ingress or
in such a way as to reduce to a minimum the risks egress of substances - A medical device must be
16. The design, manufacture and packaging of a
posed by substances leaking from the device. 7.6 designed and manufactured in a way that ensures
medical device shall minimize any risk to a patient,
Devices must be designed and manufactured in such that any risks associated with unintentional ingress of
user or other person from reasonably foreseeable
a way as to reduce as much as possible, risks posed substances into, or unintentional egress of
hazards, including (e) fluid leaking from or entering
by the unintentional ingress of substances into the substances out of, the device are minimized, having
into the device
device taking into account the device and the nature regard to the nature of the environment in which the
of the environment in which it is intended to be used. device is intended to be used.
8. Infection and microbial contamination 8. Infection and microbial contamination
8.1 Minimization of risk of infection and
8.1 The devices and manufacturing processes must
contamination (1) A medical device must be
be designed in such a way as to eliminate or reduce
designed and manufactured in a way that ensures
as far as possible the risk of infection to the patient,
that the risk of infection to a patient, a user, or any
user and third parties.
other person, is eliminated or minimized.
(2) The device must be designed in a way that: (a)
allows it to be easily handled; and (b) if appropriate,
minimizes contamination of the device by the patient,
or contamination of the patient by the device, during
use.
8.2 Control of non-human tissues, cells and other
substances (1) This clause applies in relation to a
8.2 Tissues of animal origin must originate from medical device that contains tissues, cells or
animals that have been subjected to veterinary substances of non-human origin. (2) If the tissues,
controls and surveillance adapted to the intended use cells or substances originated from animals, the
of the tissues. animals must have been subjected to appropriate
veterinary controls and supervision, having regard to
the intended use of the tissues, cells or substances.
(3) If the medical device contains tissues, cells or
Notified Bodies shall retain information on the substances of animal origin, a record must be kept of
geographical origin of the animals. the country of origin of each animal from which the
tissues, cells or substances originated.
Page 5 of 24

Processing, preservation, testing and handling of
Processing, preservation, testing and handling of
tissues, cells and substances of animal origin
tissues, cells and substances of animal origin must be
should be carried out so as to provide optimal
carried out so as to provide optimal security.
safety.
In particular safety with regard to viruses and
other transmissible agents should be addressed
by implementation of validated methods of
elimination or viral inactivation in the course of
the manufacturing process.
8.2.2 In some jurisdictions products
incorporating human tissues, cells and
substances may be considered medical devices.
In this case, selection, processing, preservation,
testing and handling of tissues, cells and
substances of such origin should be carried out
so as to provide optimal safety. In particular
safety with regard to viruses and other
transmissible agents should be addressed by
implementation of validated methods of
elimination or viral inactivation in the course of
the manufacturing process.
8.3 Devices delivered in a sterile state must be
designed, manufactured and packed in a non-
reusable pack and/or according to appropriate
procedures to ensure they are sterile when
placed on the market and remain sterile, under
the storage and transport conditions laid down,
until the protective packaging is damaged or
opened.
8.4 Devices delivered in a sterile state must
have been manufactured and sterilized by an
appropriate, validated method.
8.5 Devices intended to be sterilized must be
manufactured in appropriately controlled (e.g.
environmental) conditions.
(4) The processing, preservation, testing and
handling of tissues, cells or substances of non-
human origin must be carried out in a way that
ensures the highest standards of safety for a patient,
the user of the device, or any other person.
In particular safety with regard to viruses and other
(5) In particular, the manufacturing process must
transferable agents must be addressed by
implement validated methods of elimination, or viral
implementation of validated methods of elimination or
inactivation, in relation to viruses and other
viral inactivation in the course of the manufacturing
transmissible agents.
process.
8.3 Medical devices to be supplied in a sterile state
8.3 Devices delivered in a sterile state must be (1) This clause applies in relation to a medical device
designed, manufactured and packed in a non- that is intended by the manufacturer to be supplied in
reusable pack and/or according to appropriate a sterile state. (2) The device must be designed,
procedures to ensure they are sterile when placed on manufactured and packed in a way that ensures that
the market and remain sterile, under the storage and the device is sterile when it is supplied, and will
transport conditions laid down, until the protective remain sterile, if stored and transported in
packaging is damaged or opened. accordance with the directions of the manufacturer,
until the protective packing is damaged or opened.
17. A medial device that is to be sold in a sterile
8.4 Devices delivered in a sterile state must have
condition shall be manufactured and sterilized […], (3) The device must be manufactured and sterilized
been manufactured and sterilized by an appropriate,
and the sterilization method used shall be using an appropriate validated method.
validated method.
validated.
8.5 Devices intended to be sterilized must be
...be manufactured and sterilized under (4) The device must be manufactured in
manufactured in appropriately controlled (e.g.
appropriately controlled conditions… appropriately controlled conditions.
environmental) conditions.
Page 6 of 24

8.6 Packaging systems for non-sterile devices
must keep the product without deterioration at
the level of cleanliness stipulated and,
if the devices are to be sterilized prior to use,
minimize the risk of microbial contamination.
The packaging system must be suitable taking
account of the method of sterilisation indicated
by the manufacturer.
8.7 The packaging and/or label of the device
must distinguish between identical or similar
products sold in both sterile and non-sterile
condition.
9.Construction and environmental properties 9.Construction and environmental properties
9.1 If the device is intended for use in
combination with other devices or equipment,
the whole combination, including the connection
system must be safe and must not impair the
specified performances of the devices. Any
restrictions on use must be indicated on the label
or in the instructions for use.
9.2 Devices must be designed and manufactured 9.2 Devices must be designed and manufactured in
in such a way as to remove or minimize as far as such a way as to remove or minimize as far as is
is practicable: possible:
8.4 Medical devices to be supplied in a non-sterile
state (1) A medical device that is not intended by the
8.6 Packaging systems for non-sterile devices must
manufacturer to be supplied in a sterile state must be
keep the product without deterioration at the level of
packed in a way that ensures that the device
cleanliness stipulated and,
maintains the level of cleanliness stipulated by the
manufacturer.
(2) If the device is intended to be sterilized before it
if the devices are to be sterilized prior to use, is used, the device must be packed in a way that: (a)
minimize the risk of microbial contamination. ensures that the risk of microbial contamination is
minimized; and
The packaging system must be suitable taking (b) is suitable having regard to the method of
account of the method of sterilisation indicated by the sterilization that the manufacturer indicates is to be
manufacturer. used for the device.
(3) The device must be manufactured in
appropriately controlled conditions.
8.5 Distinction between medical devices supplied in
sterile and non-sterile state - If a medical device is
8.7 The packaging and/or label of the device must
supplied in both a sterile and a non-sterile state, the
distinguish between identical or similar products sold
information provided with the device must clearly
in both sterile and non-sterile condition.
indicate whether the device is in a sterile state or in a
non-sterile state.
9. Construction and environmental properties
9.1 Medical devices intended to be used in
combination with other devices or equipment - A
9.1 If the device is intended for use in combination medical device that is intended by the manufacturer
with other devices or equipment, the whole to be used in combination with another medical
18. A medical device that is part of a system shall
combination, including the connection system must device or other equipment (including a connection
be compatible with every other component or part
be safe and must not impair the specified system) must be designed and manufactured in a
of the system with which it interacts and shall not
performances of the devices. Any restrictions on use way that ensures that: (a) the medical devices, and
adversely affect the performance of that system.
must be indicated on the label or in the instructions any other device or equipment with which it is used,
for use. 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 Minimization of risks associated with use of
medical devices
Page 7 of 24
- the risk of injury, in connection with their
physical features, including the volume/pressure
ratio, dimensional and where appropriate the
ergonomic features,
- risks connected with reasonably foreseeable
environmental conditions, such as magnetic
fields, external electrical influences, electrostatic
discharge, pressure, temperature or variations in
pressure and acceleration,
- the risks of reciprocal interference with other - the risks of reciprocal interference with other
devices normally used in the investigations or for devices normally used in the investigations or for the
the treatment given,
- risks arising where maintenance or calibration
are not possible (as with implants),
from aging of materials used or
loss of accuracy of any measuring or control
mechanism.
9.3 Devices must be designed and manufactured
in such a way as to minimize the risks of fire or
explosion during normal use and in single fault
condition. Particular attention must be paid to
devices whose intended use includes exposure
to flammable substances or to substances,
which could cause combustion.
10. Devices with a measuring function
10.1. Devices with a measuring function must be
designed and manufactured in such a way as to
provide sufficient accuracy and stability within
appropriate limits of accuracy and taking account
of the intended purpose of the device. The limits
of accuracy should be indicated by the
manufacturer.
- the risk of injury, in connection with their physical
features, including the volume/pressure ratio, (a) the risk of injury arising from the physical features
dimensional and where appropriate the ergonomic of the device;
features,
- risks connected with reasonably foreseeable
environmental conditions, such as magnetic fields,
(b) any risks associated with reasonably foreseeable
external electrical influences, electrostatic discharge,
environmental conditions;
pressure, temperature or variations in pressure and
acceleration,
(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
treatment given,
to be used;
- risks arising where maintenance or calibration are (d) any risks arising if maintenance or calibration of
not possible (as with implants), the device is not possible;
(e) any risks associated with the ageing of materials
from aging of materials used or
used in the device;
loss of accuracy of any measuring or control (f) any risks associated with the loss of accuracy of
mechanism. any measuring or control mechanism of the device;
9.3 Devices must be designed and manufactured in
such a way as to minimize the risks of fire or (g) the risk of fire or explosion occurring during
16. The design, manufacture and packaging of a
explosion during normal use and in single fault normal use of the device, and in the event of a single
medical device shall minimize any risk to a patient,
condition. Particular attention must be paid to devices fault condition, especially if the device is intended to
user or other person from reasonably foreseeable
whose intended use includes exposure to flammable be exposed to flammable substances or substances
hazards, including (a) flammability or explosion
substances or to substances, which could cause that can cause combustion.
combustion.
10. Devices with a measuring function 10. Devices with a measuring function
(1) This clause applies in relation to a medical device
10.1. Devices with a measuring function must be
19. A medical device that performs a measuring that has a measuring function. (2) The device must
designed and manufactured in such a way as to
function shall be designed to perform that function be designed and manufactured in a way that ensures
provide sufficient accuracy and stability within
within tolerance limits that are appropriate for the that the device provides accurate, precise and stable
appropriate limits of accuracy and taking account of
medical conditions, purposes and uses for which measurements within the limits indicated by the
the intended purpose of the device. The limits of
the device is manufactured, sold or represented. manufacturer and having regard to the intended
accuracy must be indicated by the manufacturer.
purpose of the device.
Page 8 of 24
10.2 The measurement, monitoring and display
scale must be designed in line with ergonomic
principles, taking account of the intended
purpose of the device.
10.3 The measurements made by devices with a
measuring function must be expressed in legal
units as required by the legislation governing
such expression of each jurisdiction in which the
device is to be sold.
11. Protection against radiation
11.1 General
11.1.1 Devices shall be designed and
manufactured in such a way that exposure of
patients, users and other persons to radiation
shall be reduced as far as possible compatible
with the intended purpose, whilst not restricting
the application of appropriate specified levels for
therapeutic and diagnostic purposes.
11.2 Intended radiation
11.2.1 Where devices are designed to emit
hazardous levels of radiation necessary for a
specific medical purpose the benefit of which is
considered to outweigh the risks inherent in the
emission, it must be possible for the user to
control the emissions.
Such devices shall be designed and
manufactured to ensure reproducibility and
tolerance of relevant variable parameters.
11.2.2 Where devices are intended to emit
potentially hazardous, visible and/or invisible
radiation, they must be fitted, where practicable,
with visual displays and/or audible warnings of
such emissions.
10.2 The measurement, monitoring and display scale
must be designed in line with ergonomic principles,
taking account of the intended purpose of the device.
10.3 The measurements made by devices with a
measuring function must be expressed in legal units
conforming to the provisions of Council Directive
80/181/EEC, as last amended by Directive
89/617/EEC.
11. Protection against radiation
11.1 General
11.1.1 Devices shall be designed and manufactured
in such a way that exposure of patients, users and
other persons to radiation shall be reduced as far as
possible compatible with the intended purpose, whilst
not restricting the application of appropriate specified
levels for therapeutic and diagnostic purposes.
11.2 Intended radiation
11.2.1 Where devices are designed to emit
hazardous levels of radiation necessary for a specific
medical purpose the benefit of which is considered to
outweigh the risks inherent in the emission, it must be
possible for the user to control the emissions.
Such devices shall be designed and manufactured to
ensure reproducibility and tolerance of relevant
variable parameters.
11.2.2 Where devices are intended to emit potentially
hazardous, visible and/or invisible radiation, they
must be fitted, where practicable, with visual displays
and/or audible warnings of such emissions.
Page 9 of 24
(3) The measurement, monitoring and display scale
of the device must be designed and manufactured in
accordance with ergonomic principles, having regard
to the intended purpose of the device.
(4) The measurements made by the device must be
expressed: (a) in standard international units; or (b) if
the Secretary approves, for a particular device, units
of measurement that are not standard international
units – in units approved.
11. Protection against radiation
11.1 Minimization of exposure to radiation
A medical device must be designed and
manufactured in a way that ensures that the
16. The design, manufacture and packaging of a
exposure of a patient, the user, or any other person,
medical device shall minimize any risk to a patient,
to radiation is minimized, having regard to the levels
user or other person from reasonably foreseeable
of radiation required to enable the device to perform
hazards, including (c) radiation
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 the 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 to the emission. (2)
The device must be designed and manufactured in a
way that ensures that the user can control the level
of the emission.
(3) The device must be designed and manufactured
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 Unintended radiation
11.3.1 Devices shall be designed and
manufactured in such a way that exposure of
patients, users and other persons to the
emission of unintended, stray or scattered
radiation is reduced as far as possible.
11.4 Instructions
11.4.1 The operating instructions for devices
emitting radiation must give detailed information
as to the nature of the emitted radiation,
means of protecting the patient and the user
and on ways of avoiding misuse
and of eliminating the risks inherent in
installation.
11.5 Ionizing radiation
11.5.1 Devices intended to emit ionizing
radiation must be designed and manufactured in
such a way as to ensure that, where practicable,
the quantity, geometry and energy distribution
(or quality) of radiation emitted can be varied
and controlled taking into account the intended
use.
11.5.2 Devices emitting ionizing radiation
intended for diagnostic radiology shall be
designed and manufactured in such a way as to
achieve appropriate image and/or output quality
for the intended medical purpose whilst
minimizing radiation exposure of the patient and
user.
11.3 Unintended radiation
11.3.1 Devices shall be designed and manufactured
in such a way that exposure of patients, users and
other persons to the emission of unintended, stray or
scattered radiation is reduced as far as possible.
11.4 Instructions
11.4.1 The operating instructions for devices emitting
radiation must give detailed information as to the
nature of the emitted radiation,
means of protecting the patient and the user
and on ways of avoiding misuse
and of eliminating the risks inherent in installation.
11.5 Ionizing radiation
11.5.1 Devices intended to emit ionizing radiation
must be designed and manufactured in such a way as
to ensure that, where practicable, the quantity,
geometry and quality of radiation emitted can be
varied and controlled taking account the intended
use.
11.5.2 Devices emitting ionizing radiation intended for
diagnostic radiology shall be designed and
manufactured in such a way as to achieve
appropriate image and/or output quality for the
intended medical purpose whilst minimizing radiation
exposure of the patient and user.
Page 10 of 24
11.3 Minimization of exposure to unintended
radiation
A medical device must be designed and
manufactured 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 minimized.
11.4 Operating instructions
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 ionizing
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 ionizing radiation. (2)
The device must be designed and manufactured 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
manufactured 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
minimized.
11.5.3 Devices emitting ionizing radiation,
intended for therapeutic radiology shall be
designed and manufactured in such a way as to
enable reliable monitoring and control of the
delivered dose, the beam type and energy and
where appropriate the energy distribution of the
radiation beam.
12. Requirements for medical devices
connected to or equipped with an energy
source
12.1 Devices incorporating electronic
programmable systems must be designed to
ensure the repeatability, reliability and
performance of these systems according to the
intended use.
In the event of a single fault condition in the
In the event of a single fault condition (in the system)
system, appropriate means should be adopted to
appropriate means should be adopted to eliminate or
eliminate or reduce as far as possible
reduce as far as possible consequent risks.
consequent risks.
12.2 Devices where the safety of the patients
depends on an internal power supply must be
equipped with a means of determining the state
of the power supply.
12.3 Devices where the safety of the patients
depends on an external power supply must
include an alarm system to signal any power
failure.
11.5.3 Devices emitting ionizing radiation, intended
for therapeutic radiology shall be designed and
manufactured in such a way as to enable reliable
monitoring and control of the delivered dose, the
beam type and energy and where appropriate the
quality of radiation.
12. Requirements for medical devices connected
to or equipped with an energy source
12.1 Devices incorporating electronic programmable
systems must be designed to ensure the repeatability,
reliability and performance of these systems
according to the intended use.
12.2 Devices where the safety of the patients
depends on an internal power supply must be
equipped with a means of determining the state of the
power supply.
12.3 Devices where the safety of the patients
depends on an external power supply must include an
alarm system to signal any power failure.
Page 11 of 24
(4) If the device is intended to be used for therapeutic
radiology, the device must be designed and
manufactured in a way that ensures that the
delivered does of radiation, the type and energy of
the radiation beam and, if appropriate, the energy
distribution of the radiation beam, can be reliably
controlled and monitored.
12. Medical devices connected to or equipped
with an energy source
12.1 Medical devices incorporating electronic
programmable systems - A medical device that
20. If a medical device consists of or contains
incorporates an electronic programmable system
software, the software shall be designed to
must be designed and manufactured in a way that
perform as intended by the manufacturer, and the
ensures that: (a) the performance, reliability, and
performance of the software shall be validated.
repeatability of the system are appropriate for the
intended purpose of the device; and
(b) any consequent risks associated with a single
fault condition in the system are minimized.
12.2 Safety dependent on internal 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 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 Devices intended to monitor one or more
clinical parameters of a patient must be
equipped with appropriate alarm systems to alert
the user of situations which could lead to death
or severe deterioration of the patient's state of
health.
12.5 Devices must be designed and
manufactured in such a way as to minimize the
risks of creating electromagnetic fields, which
could impair the operation of other devices or
equipment in the usual environment.
12.6 Protection against electrical risks
Devices must be designed and manufactured in
such a way as to avoid, as far as possible, the
risk of accidental electric shocks during normal
use and in single fault condition, provided the
devices are installed correctly.
12.7 Protection against mechanical and
thermal risks
12.7.1 Devices must be designed and
manufactured in such a way as to protect the
patient and user against mechanical risks
connected with, for example, resistance to
movement, instability and moving parts.
12.7.2 Devices must be designed and
manufactured in such a way as to reduce to the
lowest possible level the risks arising from
vibration generated by the devices, taking
account of technical progress and of the means
available for limiting vibrations, particularly at
source, unless the vibrations are part of the
specified performance.
12.4 Medical devices intended to monitor clinical
parameters - A medical device that is intended by the
12.4 Devices intended to monitor one or more clinical
manufacturer to monitor one or more clinical
parameters of a patient must be equipped with
parameters of a patient must be fitted with an
appropriate alarm systems to alert the user of
appropriate alarm system to warn the user if a
situations which could lead to death or severe
situation has developed that could lead to the death
deterioration of the patient's state of health.
of the patient or the severe deterioration of the
patient’s health.
12.5 Minimization of risk of electromagnetic fields - A
12.5 Devices must be designed and manufactured in medical device must be designed and manufactured
such a way as to minimize the risks of creating in a way that ensures that the risk of an
electromagnetic fields, which could impair the electromagnetic field being created that could impair
operation of other devices or equipment in the usual the operation of other devices or equipment being
environment. used in the vicinity of the medical device is
minimized.
12.6 Protection against electrical risks 12.6 Protection against electrical risks
A medical device must be designed and
manufactured in a way that ensures that, as far as
Devices must be designed and manufactured in such
16. The design, manufacture and packaging of a possible, when the device is installed correctly, and
a way as to avoid, as far as possible, the risk of
medical device shall minimize any risk to a patient, the device is being used for an intended purpose
accidental electric shocks during normal use and in
user or other person from reasonably foreseeable under normal conditions of use and in the event of a
single fault condition, provided the devices are
hazards, including (d) electrical, single fault condition, patients and users are
installed correctly.
protected against the risk of accidental electric
shock.
12.7 Protection against mechanical and thermal
12.7 Protection against mechanical risks
risks
A medical device must be designed and
12.7.1 Devices must be designed and manufactured
manufactured in a way that ensures that a patient,
in such a way as to protect the patient and user
mechanical or thermal hazards the user, and any other person, is protected against
against mechanical risks connected with, for
any mechanical risks associated with the use of the
example, resistance, stability and moving parts.
device.
12.8 Protection against risks associated with
12.7.2 Devices must be designed and manufactured vibration - (1) A medical device must be designed
in such a way as to reduce to the lowest possible and manufactured in a way that ensures that any
level the risks arising from vibration generated by the risks associated with vibrations generated by the
devices, taking account of technical progress and of device are minimized. (2) If vibrations are not part of
the means available for limiting vibrations, particularly the intended performance of the device, particular
at source, unless the vibrations are part of the attention must be given to relevant technical
specified performance. progress, and the available means, for limiting
vibrations, particularly at source.
Page 12 of 24

12.7.3 Devices must be designed and
manufactured in such a way as to reduce to the
lowest possible level the risks arising from the
noise emitted, taking account of technical
progress and of the means available to reduce
noise, particularly at source, unless the noise
emitted is part of the specified performance.
12.7.4 Terminals and connectors to the
electricity, gas or hydraulic and pneumatic
energy supplies which the user has to handle
must be designed and constructed in such a way
as to minimize all possible risks.
12.7.5 Accessible parts of devices (excluding the
parts or areas intended to supply heat or reach
given temperatures) and their surroundings must
not attain potentially dangerous temperatures
under normal use.
12.8 Protection against the risks posed to the 12.8 Protection against the risks posed to the
patient by energy supplies or substances patient by energy supplies or substances
12.8.1 Devices for supplying the patient with
energy or substances must be designed and
constructed in such a way that the flow-rate can
be set and maintained accurately enough to
guarantee the safety of the patient and of the
user.
12.7.3 Devices must be designed and manufactured
in such a way as to reduce to the lowest possible
level the risks arising from the noise emitted, taking
account of technical progress and of the means
available to reduce noise, particularly at source,
unless the noise emitted is part of the specified
performance.
12.7.4 Terminals and connectors to the electricity,
gas or hydraulic and pneumatic energy supplies
which the user has to handle must be designed and
constructed in such a way as to minimize all possible
risks.
12.7.5 Accessible parts of devices (excluding the
parts or areas intended to supply heat or reach given
temperatures) and their surroundings must not attain
potentially dangerous temperatures under normal
use.
12.8.1 Devices for supplying the patient with energy
or substances must be designed and constructed in
such a way that the flow-rate can be set and
maintained accurately enough to guarantee the safety
of the patient and of the user.
Page 13 of 24
12.9 Protection against risks associated with
noise - (1) A medical device must be designed and
manufactured in a way that ensures that any risks
associated with noise emitted by the device are
minimized. (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 manufactured 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
minimized.
12.11 Protection against risks associated with
heat - A medical device must be designed and
manufactured in a way that ensures that, during
normal use, any accessible part of the device (except
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 manufactured in a
way that ensures that: (a) the delivered amount of
energy or the substance can be set and maintained
accurately to ensure the safety of the patient and the
user; and [see (b), below]
 (3) The device must be fitted with a means of
12.8.2 Devices must be fitted with the means of 12.8.2 Devices must be fitted with the means of indicating or, if appropriate, preventing inadequacies
preventing and/or indicating any inadequacies in preventing and/or indicating any inadequacies in the in the amount of energy or the substance
the flow-rate, which could pose a danger. flow-rate, which could pose a danger. administered that might cause danger to the patient,
the user or any other person.

Devices must incorporate suitable means to
prevent, as far as possible, the accidental
release of dangerous levels of energy from an
energy and/or substance source.
Devices must incorporate suitable means to prevent,
(b) as far as possible, the accidental release of
as far as possible, the accidental release of
dangerous levels of energy or the substance is
dangerous levels of energy from an energy and/or
prevented.
substance source.

12.8.3 The function of the controls and indicators 12.9 The function of the controls and indicators must (4) The functions of each control and indicator on the
must be clearly specified on the devices. be clearly specified on the devices. device must be clearly specified on the device.

(5) If the instructions for the operation of the device,

Where a device bears instructions required for
its operation or indicates operating or adjustment
parameters by means of a visual system, such
information must be understandable to the user
and, as appropriate, the patient.
Where a device bears instructions required for its
or the operating or adjustment parameters for the
operation or indicates operating or adjustment
device, are displayed by means of a visual system
parameters by means of a visual system, such
incorporated into the device, the instructions or
information must be understandable to the user and,
parameters must be able to be understood by the
as appropriate, the patient.
user and, if appropriate, by the patient.

12.13 Active implantable medical devices - N/A

Page 14 of 24
 13. Information to be provided with medical
13. Information supplied by the manufacturer 13. Information supplied by the manufacturer
devices

13.1 Information to be provided with medical

devices - general: (1) The following information
13.1 Each device should be accompanied by the
13.1 Each device must be accompanied by the must be provided with a medical device: (a)
information needed to identify the manufacturer,
information needed to use it safely and to identify the information identifying the device; (b) information
to use it safely and to ensure the intended
manufacturer, taking account of the training and identifying the manufacturer of the device; (c)
performance, taking account of the training and
knowledge of the potential users. information explaining how to use the device safely,
knowledge of the potential users.
having regard to the training and knowledge of
potential users of the device.

(2) In particular: (a) the information required by

This information comprises the details on the clause 13.3 must be provided with a medical device;
This information comprises the details on the label
label and the data in the instructions for use, and and (b) if instructions for use of the device are
and the data in the instructions for use.
should be easily understood. required, the information required by clause 13.5
must be provided in the instructions for use.

Labeling for medical devices

GHTF.SG1.N009R6

23. (1) Subject to subsection (3), the information

required by subsection 21 (1) shall, as a minimum,
be in either English or French. (2) Subject to
subsection (3), where the directions for use are
Country-specific requirements for labeling, text,
supplied in only one official language at the time of
content, or the format of labels or labeling should
sale, directions for use in the other official
be kept to a minimum and, where they currently
language shall be made available by the
exist, eliminated as the opportunity arises.
manufacturer as soon as possible at the request of (3) The information: (a) must be provided in English;
Taking into consideration the type of user
the purchaser. (3) The directions for use in respect and (b) may also be provided in any other language.
anticipated for the device, national language
of a medical device that is sold at a self-service
requirements should be kept to a minimum.
display shall, as a minimum, be in both English
Instructions for use should be written in terms
and French. 21. (2) The information required
readily understood by the intended user.
pursuant to subsection (1) shall be expressed in a
legible, permanent and prominent manner, in
terms that are easily understood by the intended
user.

Page 15 of 24
 13.2 Information to be provided with medical
devices – location (1) Unless it is impracticable to
do so, the information required to be provided with a
22. (1) Subject to subsection (2), if a medical
As far as practicable and appropriate, the medical device must be provided on the device itself.
As far as practicable and appropriate, the information device is intended to be sold to the general public,
information needed to use the device safely must (2) If it is not practicable to comply with sub-clause
needed to use the device safely must be set out on the information required by subsection 21 (1) shall:
be set out on the device itself and/or on the (1) in relation to the provision of the information, the
the device itself and/or on the packaging for each unit (a) be set out on the outside of the package that
packaging for each unit and/ or on the packaging information must be provided: (a) on the packaging
or, where appropriate, on the sales packaging. contains the device; and (b) be visible under
of multiple devices. used for the device; or (b) in the case of devices that
normal conditions of sale.
are packaged together because individual packaging
of the devices is not practicable – on the outer
packaging used for the devices.

(2) Where a package that contains a medical

(3) If it is not practicable to comply with sub-clause
If individual packaging of each unit is not device is too small to display all the information in
If individual packaging of each unit is not practicable, (1) or (2) in relation to the provision of the
practicable, the information must be set out in accordance with section 21, the directions for use
the information must be set out in the leaflet supplied information, the information must be provided on a
the leaflet, packaging insert or other means shall accompany the device but need not be set
with one or more devices. leaflet or other document supplied with the device
supplied with one or multiple devices. out on the outside of the package or be visible
(for example, a packaging insert).
under normal conditions of sale.

The format, content and location of labeling (4) The format, content, and location of the
should be appropriate to the particular device information must be appropriate for the device and
and its intended purpose. its intended purpose.

13.4 Instructions for use – when not required -

Instructions for use must be included in the packaging
Instructions may not be needed or may be Instructions for use of a medical device need not be
for every device. By way of exception, no such 21. (1) (i) the directions for use, unless directions
abbreviated for devices of low or moderate risk if provided with the device, or may be abbreviated, if:
instructions for use are needed for devices in Class I are not required for the device to be used safely
they can be used safely and as intended without (a) the device is a Class I medical device or a Class
or Class IIa if they can be used safely without any and effectively;
any such instructions. IIa medical device; and (b) the device can be used
such instructions.
safely for its intended purpose without instructions.

The use of internationally recognized (i.e.

13.2 Where appropriate, this information should take
standardized) symbols should be encouraged (5) Any number, letter, symbol, or letter or number in
the form of symbols. Any symbol or identification
provided that device safety is not compromised a symbol, used in the information must be legible
color used must conform to the harmonized
by a lack of understanding on the part of the and at least 1 millimeter high.
standards.
patient or user.

(6) If a symbol that is not included in a medical

Where the meaning of the symbol is not obvious device standard is used in the information provided
In areas for which no standards exist, the symbols
to the device user (who, with some products, with the device, or in the instructions for use of the
and colors must be described in the documentation
could be a member of the public), it should be device, the meaning of the symbol must be explained
supplied with the device.
described in words associated with the symbol. in the information provided with the device or the
instructions for use of the device.

Page 16 of 24
Information on device use and instructions may
be provided to the user in various media and by
several means such as printed documents,
through a display screen incorporated into the
device, trans-telephonically, magnetic or optical
media, etc. Whatever the media or the means,
information should be targeted to the anticipated
user population.

21. (1) No person shall import or sell a medical

The labeling should bear the following 13.3 Information to be provided with medical
13.3 The label must bear the following particulars: device unless the device has a label that sets out
particulars. In general: devices – particular requirements
the following information:

a) the name or trade name and address of the

a) the name or trade name and address of the
manufacturer. For devices imported into the
manufacturer; and [go to ER 13.4]. For imported
Community, in view of their distribution in the
devices, the label, or the outer packaging, or
Community, the label, or the outer packaging, or
instructions for use, may be required to contain
instructions for use, shall contain in addition the name 1. The manufacturer’s name, or trade name, and
in addition, the name and address of either the (b) the name and address of the manufacturer;
and address of either the person responsible referred address
importer established within the importing country
to in Article 14. (2) or of the authorized representative
or of an authorized representative of the
of the manufacturer established within the Community
manufacturer established within the importing
or of the importer established within the Community,
country.
as appropriate;

(a) the name of the device; (c) the identifier of the

device, including the identifier of any medical
device that is part of a system, test kit, medical
b) sufficient details for the user to identify the device group, medical device family or medical
b) the details strictly necessary for the user to identify 3. Sufficient information to enable a user to identify
device or, where relevant, the contents of any device group family; (e) if the contents are not
the device and the contents of the packaging; the device, or if relevant, the contents of packaging
packaging; readily apparent, an indication of what the
package contains, expressed in terms appropriate
to the device, such as the size, net weight, length,
volume or number of units;

c) see below, equivalent to MDD ER 13.5;

(f) the words “Sterile” and “Stérile”, if the 10. For a sterile device, the word ‘sterile’ and
c) where appropriate, the word "STERILE"; manufacturer intends the device to be sold in a information about the method that was used to
sterile condition; sterilize the device

d) where appropriate, the batch code, preceded by (d) in case of a Class III or Class IV device, the
the word "LOT", or the serial number; control number;

Page 17 of 24
d) an indication of the date until which the device
may safely be used (i.e. put into service),
expressed as the year and month (e.g. on single-
use disposable devices) where this is relevant;
e) for devices other than those covered by (d)
above, and as appropriate to the type of device,
an indication of the date of manufacture. This
indication may be included in the batch code or
serial number;
f) any special storage and/ or handling conditions
on the external packaging;
g) any warnings and/ or precautions;
h) see below, equivalent to MDD ER 13.6 b).
i) see below, equivalent to MDD ER 13.6 d);
j) see below, equivalent to MDD ER 13.6 i).
Where applicable:
k) see below, equivalent to MDD ER 13.6 g);
l) an indication that the device has been
specified by the manufacturer for single-use
only;
m) an indication that the device is for use by a
single individual and has been manufactured
according to a written prescription or pattern (i.e. made device";
it is custom-made);
(g) the expiry date of the device, if the device has
e) where appropriate, an indication of the date by 11. If applicable, a statement of the date (expressed
one, to be determined by the manufacturer on the
which the device should be used, in safety, expressed as a month and year) up to when the device can be
basis of the component that has the shortest
as the year and month; safely used
projected useful life;
12. If the information provided with the device does
l) year of manufacture for active devices other than not include the information mentioned in item 11 – a
those covered by e). This indication may be included statement of the date of manufacture of the device
in the batch or serial number; (this may be included in the batch code, lot number
or serial number of the device)
(j) any special storage conditions applicable to the 4. Any particular handling or storage requirements
i) any special storage and/or handling conditions;
device applying to the device
5. Any warnings, or precautions that should be taken,
k) any warnings and/or precautions to take;
in relation to the use of the device
f) where appropriate, an indication that the device is 7. If applicable, an indication that the device is
for single use; intended for a single use only
75. No person shall import or sell a medical device
in respect of which an authorization has been
issued pursuant to section 72 (Authorization), or a
Class I or II custom-made device, unless the 8. If applicable, an indication that the device has
g) if the device is custom-made, the words "custom
device has a label that (a) sets out the name of the been custom-made for a particular individual and is
manufacturer; (b) sets out the name of the device; intended for use only by that individual
and (c) specifies whether the device is a custom-
made device or is being imported or sold for
special access.
Page 18 of 24
 86. No person shall import or sell a medical device
for investigational testing unless the device has a
label that sets out (a) the name of the
manufacturer; (b) the name of the device; (c) the
statements “Investigational Device” and
“Instrument de recherche”, or any other statement,
in English and French, that conveys that meaning;
n) an indication that the device is intended for (d) the statements “To Be Used by Qualified 9. If applicable, an indication that the device is
h) if the device is intended for clinical investigations,
clinical and/ or performance investigations prior Investigators Only” and “Réservé uniquement à intended to be used only for clinical or performance
the words "exclusively for clinical investigations";
to placing it on the market; l’usage de chercheurs compétents”, or any other investigations before being supplied
statement, in English and French, that conveys
that meaning; and (e) in the case of an IVDD, the
statements “The performance specifications of this
device have not been established” and “Les
specifications de rendement de l’instrument n’ont
pas été établies”, or any other statement, in
English and French, that conveys that meaning.

o) an indication that the device is intended only

for presentation or demonstration purposes [see
MDD Article 4, § 3];

p) see below, equivalent to MDD ER 13.6 c);

q) see below, equivalent to MDD ER 13.6 e);

r) see below, equivalent to MDD ER 13.6 f);

s) see below, equivalent to MDD ER 13.6 h);

t) see below, equivalent to MDD ER 13.6 j);

6. Any special operating instructions for the use of

j) any special operating instructions;
the device
10. For a sterile device, the word ‘sterile’ and
m) where applicable, method of sterilisation. information about the method that was used to
sterilize the device
13. If applicable, the words ‘for export only’

Page 19 of 24
 (h) unless self-evident to the intended user, the
medical conditions, purposes and uses for which
[continued from a)] the intended purpose, user 13.4 If the intended purpose of the device is not 2. The intended purpose of the device, the intended
the device is manufactured, sold or represented,
and patient population of the device where these obvious to the user, the manufacturer must clearly user of the device, and the kind of patient on whom
including the performance specifications of the
are not obvious state it on the label and in the instructions for use. the device is intended to be used
device if those specifications are necessary for
proper use;

c) an indication of either the batch code/ lot

13.5 Wherever reasonable and practicable, the
number (e.g. on single-use disposable devices)
devices and detachable components must be
or serial number (e.g. on electrically-powered
identified, where appropriate in terms of batches, to
medical devices), where relevant, and to allow
allow all appropriate action to detect any potential risk
appropriate actions to trace and recall the
posed by the devices and detachable components.
devices and detachable components;

13.5 Instructions for use – information to be

13.6 Where appropriate, the instructions for use must
included If instructions for use of a medical device
contain the following particulars: a) the details
are required to be provided with the device, the
referred to in section 13.3, with the exception of d)
instructions must include the information mentioned
and e);
in the following table.

13.3 a) the name or trade name and address of the

manufacturer. For devices imported into the
Community, in view of their distribution in the
Community, the label, or the outer packaging, or
instructions for use, shall contain in addition the name 1. The manufacturer’s name, or trade name, and
and address of either the person responsible referred address;
to in Article 14. (2) or of the authorized representative
of the manufacturer established within the Community
or of the importer established within the Community,
as appropriate;

13.3 b) the details strictly necessary for the user to 6. Sufficient information to enable a user to identify
identify the device and the contents of the packaging; the device, or if relevant, the contents of packaging;

11. For a sterile device, the word ‘sterile’ and

13.3 c) where appropriate, the word "STERILE"; & m)
information about the method that was used to
where applicable, method of sterilisation;
sterilize the device;
13.3 f) where appropriate, an indication that the 8. If applicable, an indication that the device is
device is for single use; intended for a single use only;

9. If applicable, an indication that the device has

13.3 g) if the device is custom-made, the words
been custom-made for a particular individual and is
"custom made device";
intended for use only by that individual;

Page 20 of 24

h) the performance intended by the manufacturer b) the performances referred to in section 3 and any
and any undesirable side-effects; undesirable side effects;
p) if the device is to be installed with or
connected to other medical devices or
equipment in order to operate as required for its
intended purpose, sufficient details of its
characteristics to identify the correct devices or
equipment to use in order to obtain a safe
combination;
i) the information needed to verify whether the
device is properly installed and can operate
correctly and safely, [see below] and calibration
needed to ensure that the device operates
properly and safely during its intended life;
plus details of the nature, and frequency of
preventative and regular maintenance,
replacement of consumable components,
q) If the device is implantable, information
regarding any particular risks in connection with
its implantation;
13.3 h) if the device is intended for clinical
investigations, the words "exclusively for clinical
investigations";
13.3 i) any special storage and/or handling conditions;
13.3 j) any special operating instructions;
13.3 k) any warnings and/or precautions to take;
13.3 l) year of manufacture for active devices other
than those covered by e). This indication may be
included in the batch or serial number;
c) if the device must be installed with or connected to
other medical devices or equipment in order to
operate as required for its intended purpose, sufficient
details of its characteristics to identify the correct
devices or equipment to use in order to obtain a safe
combination;
d) all the information needed to verify whether the
device is properly installed and can operate correctly
and safely, [see below] and calibration needed to
ensure that the devices operate properly and safely at
all times;
plus details of the nature and frequency of the
maintenance
e) where appropriate, information to avoid certain
risks in connection with implantation of the device;
Page 21 of 24
10. If applicable, an indication that the device is
intended to be used only for clinical or performance
investigations before being; supplied;
7. Any particular handling or storage requirements
applying to the device;
14. Any special operating instructions for the use of
the device;
5. Any contra-indications, warnings, or precautions
that may apply in relation to use of the device;
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 (equivalent to MDD
ER 13.4)
4. Information about the intended performance of the
device and any undesirable side effects caused by
the use of the device
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
15. Information to enable the user to verify whether
the device is properly installed and whether it can be
operated safely and correctly, including details 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 preventive maintenance of the device,
including information about the replacement of
consumable components of the device
19. For an implantable device – information about
any risks associated with its implantation
r) information regarding the risks of reciprocal
interference posed by the reasonably
foreseeable presence of the device during
specific investigations or treatment; (e.g.
electrical interference from electro-surgical
devices or magnetic field interference from
Magnetic Resonance Imagers)
k) an indication that the device is sterile and
g) the necessary instructions in the event of damage
necessary instructions in the event of damage to
to the sterile packaging and, where appropriate,
sterile packaging and, where appropriate,
details of appropriate methods of re-sterilisation;
description of methods of re-sterilization
s) if the device is reusable, information on the
appropriate processes to allow reuse, including
cleaning, disinfection, packaging and, where
appropriate, the method of re-sterilization and
any restriction on the number of reuses.
Where devices are supplied with the intention
that they be sterilized before use, the instructions
for cleaning and sterilization should be such that,
if correctly followed, the device will still comply
with the Essential Principles of Safety and
Performance of Medical Devices
(GHTF.SG1.N020R4)
j) details of any further treatment of handling
needed before the device can be used (e.g.
sterilization, final assembly, calibration etc.).
t) if the device emits radiation for medical
purposes, details of the nature, type, intensity
and distribution of this radiation;
f) information regarding the risks of reciprocal
interference posed by the presence of the device
during specific investigations or treatment;
h) if the device is reusable, information on the
appropriate processes to allow reuse, including
cleaning, disinfecting, packaging and, where
appropriate, the method of sterilisation of the device
to be re-sterilized, and any restriction on the number
of reuses.
Where devices are supplied with the intention that
they be sterilized before use, the instructions for
cleaning and sterilisation must be such that, if
correctly followed, the device will still comply with the
requirements in section I GENERAL
REQUIREMENTS.
i) details of any further treatment or handling needed
before the device can be used (for example,
sterilisation, final assembly, etc.);
j) in the case of devices emitting radiation for medical
purposes, details of the nature, type, intensity and
distribution of this radiation.
Page 22 of 24
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 imagers)
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 damaged;
and (c) if appropriate, instructions for re-sterilization
of the device;
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-sterilization of the
device); and (b) an indication of the number of times
the device may be safely reused;
13. For a medical device that is intended by the
manufacturer to be sterilized before use –
instructions for cleaning and sterilizing the device,
which, if followed, will ensure that the device
continues to comply with the relevant essential
principles
17. Information about any treatment or handling
needed before the device can be used;
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
The instructions for use should also include,
where appropriate, details allowing the medical
staff to brief the patient on any contra-
indications, warnings and any precautions to be
taken. These details should cover in particular:
i) precautions to be taken in the event of
changes in the performance of the device;
ii) precautions to be taken as regards exposure,
in reasonably foreseeable environmental
conditions, to magnetic fields, external electrical
influences, electrostatic discharge, pressure or
variations in pressure, acceleration, thermal
ignition sources, proximity to other devices, etc.
iii) adequate information regarding any medicinal
product or products which the device in question
is designed to administer, including any
limitations in the choice of substances to be
delivered
iv) precautions to be taken against any special,
unusual risks related to the disposal of the
device
v) any medicinal substances incorporated into
the device as an integral part of the device
vi) degree of accuracy claimed for devices with
measuring function
vii) any requirement for special facilities, or
special training, or particular qualifications of the
device user.
14. Clinical evaluation
14.1 Where conformity with these Essential
Principles should be based on clinical evaluation
data, such data should be established in
accordance with the relevant requirements
applicable in each jurisdiction.
The instructions for use must also include details
allowing the medical staff to brief the patient on any
contra-indications and any precautions to be taken.
These details should cover in particular:
k) precautions to be taken in the event of changes in
the performance of the device;
l) precautions to be taken as regards exposure, in
reasonably foreseeable environmental conditions, to
magnetic fields, external electrical influences,
electrostatic discharge, pressure or variations in
pressure, acceleration, thermal ignition sources, etc.
m) adequate information regarding the medicinal
product or products which the device in question is
designed to administer, including any limitations in the
choice of substances to be delivered;
n) precautions to be taken against any special,
unusual risks related to the disposal of the device;
o) medicinal substances incorporated into the device
as an integral part in accordance with section 7.4;
p) degree of accuracy claimed for devices with a
measuring function.
14. Clinical evaluation
Where conformity with the essential requirements
must be based on clinical data, as in section I (6),
such data must be established in accordance with
Annex X.
Page 23 of 24
5. Any contra-indications, warnings, or precautions
that may apply in relation to use of the device
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 results 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
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
25. Information about any medicine that is
incorporated into the device as an integral part 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.
TBA
Clinical investigations on human subjects should
be carried out in accordance with the Helsinki
Declaration adopted by the 18th World Medical
Assembly in Helsinki, Finland, in 1964, as last
amended by the 41st World Medical Assembly in
Hong Kong in 1989. It is mandatory that all
measures relating to the protection of human
subjects are carried out in the spirit of the Annex X
Helsinki Declaration. This includes every step in
the clinical investigation from first consideration
of the need and justification of the study to
publication of the results. In addition, some
countries may have specific regulatory
requirements for pre-study protocol review or
informed consent.

MARKING
MDD Article 17

CE Marking will be acceptable in Australia as soon

1. Devices, other than devices, which are custom-
as the new regulation is implemented. Until then,
made or intended for clinical investigations,
following marking is recommended: "TGA Listing
considered to meet the Essential Requirements
AUST L xxxxx" for listed devices (voluntary) and
referred to in Article 3 must bear the CE marking of
"TGA Registration AUST R xxxxx" for registered
conformity when they are placed on the market.
devices (mandatory).

2. The CE marking of conformity, as shown in Annex

XII, must appear in a visible, legible and indelible form
on the device or its sterile pack, where practicable
and appropriate, and on the instructions for use.
Where applicable, the CE marking must also appear
on the sales packaging.

It shall be accompanied by the identification number

of the notified body responsible for implementation of
the procedures set out in Annexes II, IV, V and VI.

Page 24 of 24