Essential Principles of Safety and Performance of

IVD Medical Devices

URcheckTM URS Test Strip

For

Over-The-Counter home (OTC)

Healgen Scientific Limited Liability Company

 Essential Principles Checklist
No. Essential Requirements Apply Standards, Directives, etc. Documentation of Evidence
1 GENERAL PRINCIPLES
1.1 Medical devices shall 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.
1.2 The solutions adopted by the manufacturer for the design and manufacture of
the devices shall conform to safety principles, taking account of the generally
acknowledged state of the art. When risk reduction is required, the
manufacturer shall control the risk(s) so that the residual risk(s) associated
with each hazard is judged acceptable. The manufacturer shall apply the
following principles in the priority order listed:
a) identify known or foreseeable hazards and estimate the associated risks
arising from the intended use and foreseeable misuse;
b) eliminate risks as far as reasonably practicable through inherently safe design
and manufacture;
c) reduce as far as is reasonably practicable the remaining risks by taking
adequate protection measures, including alarms
d) inform users of any residual risks
1.3 Devices shall achieve the performance 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.
1.4 The characteristics and performances referred to in Clauses 1.1, 1.2 and 1.3
shall not be adversely affected to such a degree that the health or safety of the
patient or the user 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 which can occur during normal conditions
of use and has been properly maintained in accordance with the
manufacturer’s instructions.
1.5 The devices shall be designed, manufactured and packed in such a way that
their characteristics and performances during their intended use will not be
adversely affected under transport and storage conditions (for example,
fluctuations of temperature and humidity) taking account of the instructions
and information provided by the manufacturer.
1.6 The benefits must be determined to outweigh any undesirable side effects for
the performances intended.
2 Chemical, physical and biological properties
2.1 The IVD medical devices shall be designed and manufactured in such a way
as to ensure the characteristics and performance referred to in Section 1
Particular attention shall be paid to the possibility of impairment of analytical
performance due to incompatibility between the materials used and the
specimens and/or analyte (measurand) to be detected (such as biological
tissues, cells, body fluids and micro-organisms) intended to be used with the
device, taking account of its intended purpose.
2.2 The IVD medical devices shall be designed, manufactured and packaged 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
patients, taking account of the intended purpose of the product.
2.3 The IVD medical devices shall be designed and manufactured in such a way
as to reduce as far as reasonably practicable and appropriate the risks posed by
 substances that may leach or leak from the IVD medical device. Special
attention shall be given to substances which are carcinogenic, mutagenic or
toxic to reproduction.
2.4 IVD medical devices shall be designed and manufactured in such a way as to
reduce as far as reasonably practicable and appropriate risks posed by the
unintentional ingress or egress of substances into or from the IVD medical
device taking into account the device and the nature of the environment in
which it is intended to be used.
3 Infection and microbial contamination
3.1 The IVD medical devices and manufacturing processes shall be designed in
such a way as to eliminate or to reduce as far as reasonably practicable and
appropriate the risk of infection to user, professional or lay person, or, where
applicable, other person . The design shall:
a) allow easy and safe handling; and, where necessary
b) reduce as far as reasonably practicable and appropriate any microbial leakage
from the IVD medical device and/or microbial exposure during use; and
c) prevent microbial contamination of the IVD medical device or specimen
where applicable, by the user, professional or lay person, or other person.
3.2 IVD medical devices labelled either as sterile or as having a special
microbiological state shall be designed, manufactured and packaged to ensure
they remain so when placed on the market and remain so under the transport
and storage conditions specified by the manufacturer, until the protective
packaging is damaged or opened.
3.3 IVD medical devices labelled either as sterile or as having a special
microbiological state shall have been processed, manufactured and, if
applicable, sterilized by appropriate, validated methods.
3.4 IVD medical devices intended to be sterilized shall be manufactured in
appropriately controlled (e.g. environmental) conditions.
3.5 Packaging systems for non-sterile IVD medical devices shall maintain the
integrity and cleanliness of the product.
4 IVD medical devices incorporating materials of biological origin
4.1 Where IVD medical devices include tissues, cells and substances originating
from animals, processing, preservation, testing and handling of tissues, cells
and substances of animal origin shall be carried out so as to provide optimal
safety for user, professional or lay person, or other person. In particular safety
with regard to viruses and other transmissible agents shall be addressed by
implementation of validated methods of elimination or inactivation in the
course of the manufacturing process. This may not apply to certain IVD
medical devices if the activity of the virus and other transmissible agent are
integral to the intended purpose of the IVD medical device or when such
elimination or inactivation process would compromise the performance of the
IVD medical device.The manufacturer shall retain information on the
geographical origin of the animals.
4.2 Where IVD medical devices include human tissues, cells and substances, the
selection of sources, donors and/or substances of human origin,the processing,
preservation, testing and handling of tissues, cells and substances of such
origin shall be carried out so as to provide optimal safety for user, professional
or lay person, or other person.
In particular safety with regard to viruses and other transmissible agents shall
be addressed by implementation of validated methods of elimination or
inactivation in the course of the manufacturing process. This may not apply to
certain IVD medical devices if the activity of the virus and other transmissible
agent are integral to the intended purpose of the IVD medical device or when
such elimination or inactivation process would compromise the performance
of the IVD medical device.
4.3 Where IVD medical devices include cells and substances of microbial origin,
 processing, preservation, testing and handling of cells and substances shall be
carried out so as to provide optimal safety for user, professional or lay person,
or other person. In particular, safety with regard to viruses and other
transmissible agents shall be addressed by implementation of validated
methods of elimination or inactivation in the course of the manufacturing
process. This may not apply to certain IVD medical devices if the activity of
the virus and other transmissible agent are integral to the intended purpose of
the IVD medical device or when such elimination or inactivation process
would compromise the performance of the IVD medical device.
5 Manufacturing and environmental properties
5.1 If the IVD medical device is intended for use in combination with other
devices or equipment, the whole combination, including the connection
system shall not impair the specified performance of the devices. Any
restrictions on use applying to such combinations shall be indicated on the
label and/or in the instructions for use.
5.2 IVD medical devices shall be designed and manufactured in such a way as to
remove or reduce as far as reasonably practicable and appropriate
a) the risk of injury to user, professional or lay person, or other person in
connection with their physical and ergonomic features;
b) the risk of use error due to the ergonomic features, human factors and the
environment in which the IVD medical device is intended to be used;
c) risks connected with reasonably foreseeable external influences or
environmental conditions, such as magnetic fields, external electrical and
electromagnetic effects, electrostatic discharge, pressure, humidity,
temperature or variations thereof;
d) the risks associated with the use of the IVD medical device when it comes
into contact with materials, liquids, and gases to which it is exposed during
normal conditions of use;
e) the risk associated with the possible negative interaction between software
and the environment within which it operates and interacts;
f) the risks of accidental penetration of substances into the IVD medical device;
g) the risk of incorrect identification of specimens; and
h) the risks of reasonably foreseeable interference with other devices such as
carry over between IVD medical devices.
5.3 IVD medical devices shall 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 shall be paid to IVD medical devices whose
intended use includes exposure to or use in association with flammable
substances or substances which could cause combustion.
5.4 IVD medical devices must be designed and manufactured in such a way as to
facilitate the safe disposal of any waste substances.
6 Performance characteristics
6.1 IVD medical devices shall be designed and manufactured in such a way that
the performance characteristics support the intended use, based on appropriate
scientific and technical methods. In particular, where appropriate, the design
shall address sensitivity, specificity, accuracy which is trueness and precision
(repeatability and reproducibility), control of known relevant interference and
limits of detection.These performance characteristics need to be maintained
during the lifetime of the IVD medical device as indicated by the
manufacturer.
6.2 Where the performance of devices depends on the use of calibrators and/or
control materials, the traceability of values assigned to such calibrators and/or
control materials shall be assured through available reference measurement
procedures and/or available reference materials of a higher order.
6.3 Wherever possible values expressed numerically shall be in commonly
accepted, standardised units, and understood by the users of the device.
7 Protection against radiation
7.1 IVD medical devices shall be designed, manufactured and packaged in such a
way that exposure of user, professional or lay person, or other person to the
emitted radiation (intended, unintended, stray or scattered) is reduced as far as
practicable and appropriate.
7.2 When IVD medical devices are intended to emit potentially hazardous, visible
and / or invisible radiation, they shall as far as practicable and appropriate be
a) designed and manufactured in such a way as to ensure that the characteristics
and the quantity of radiation emitted can be controlled and / or adjusted; and
b) fitted with visual displays and / or audible warnings of such emissions.
8 IVD medical devices that incorporate software and standalone IVD medical device software
8.1 For IVD medical devices which incorporate software or for standalone
software that are IVD medical devices in themselves, the software must be
validated according to the state of the art taking into account the principles of
development lifecycle, risk management, verification and validation.
9 IVD Medical devices connected to, or equipped with, an energy source
9.1 IVD medical devices where the safety of the patient depends on an internal
power supply in the IVD medical device, shall be equipped with a means of
determining the state of the power supply.
9.2 IVD medical devices shall be designed and manufactured in such a way as to
reduce as far as practicable and appropriate the risks of creating
electromagnetic interference which could impair the operation of this or other
devices or equipment in the usual environment.
9.3 IVD medical devices shall be designed and manufactured in such a way as to
provide an adequate level of intrinsic immunity to electromagnetic
disturbance to enable them to operate as intended.
9.4 IVD medical devices shall be designed and manufactured in such a way as to
avoid, as far as reasonably practicable, the risk of accidental electric shocks to
 the user, professional or lay person, or other person both during normal use of
the device and in the event of a single fault condition in the device, provided
the IVD medical device is installed and maintained as indicated by the
manufacturer.
10 Protection against mechanical and thermal risks
10.1 IVD medical devices shall be designed and manufactured in such a way as to
protect the user, professional or lay person, or other person against mechanical
risks connected with, for example, resistance to movement, instability and
moving parts.Where there are risks due to the presence of moving parts, risks
due to breakup or detachment, or leakage of substances, then appropriate
protection means must be incorporated.
10.2 IVD medical devices shall be designed and manufactured in such a way as to
reduce to the lowest practicable 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.
10.3 IVD medical devices shall be designed and manufactured in such a way as to
reduce to the lowest practicable level the risks arising from the noise emitted,
taking account of technical progress and of the means available to reduce
noise, particularly at source.
10.4 Terminals and connectors to the electricity, gas or hydraulic and pneumatic
energy supplies which the user, professional or lay person, or other person has
to handle shall be designed and constructed in such a way as to minimize all
possible risks.
10.5 Accessible parts of the IVD medical devices (excluding the parts or areas
intended to supply heat or reach given temperatures) and their surroundings
shall not attain potentially dangerous temperatures under normal use.
11 Protection against the risks posed by IVD medical devices intended by the manufacturer for self-testing
11.1 IVD medical devices intended for self-testing shall be designed and
manufactured in such a way that they perform appropriately for their intended
purpose taking into account the skills and the means available to lay persons
and the influence resulting from variation that can reasonably be anticipated in
the lay person’s technique and environment. The information and instructions
provided by the manufacturer shall be easy for the lay person to understand
and apply.
11.2 IVD medical devices intended for self-testing shall be designed and
manufactured in such a way as to reduce as far as practicable the risk of error
by the lay person in the handling of the device and, if applicable, the
specimen, and also in the interpretation of results.
11.3 IVD medical devices intended for self-testing shall, where reasonably
possible, include a procedure by which the lay person can verify that, at the
time of use, the product will perform as intended by the manufacturer.
12 Label and instructions for use
12.1 Users shall be provided with the information needed to identify the
manufacturer, to use the device safely and to ensure the intended performance,
taking account of their training and knowledge. This information shall be
easily understood.
13 Performance evaluation including analytical performance and, where appropriate, clinical performance
13.1 For an IVD medical device a performance evaluation shall be conducted in
accordance with MDA guidance. The performance evaluation shall review
analytical performance data and, where appropriate, clinical performance data
in the form of any- - literature; - performance study reports; and - experience
gained by routine diagnostic testingto establish that the IVD medical device
achieves its intended performance during normal conditions of use and that
the known, and foreseeable risks, and any undesirable effects, are minimised
and acceptable when weighed against the benefits of the intended
 performance. The depth and extent of a performance evaluation shall be
appropriate to the nature, intended use and risks of the IVD medical device,
and in accordance with MDA guidance. Note: Further information is provided
in MDA/GD/0003: Principles of Conformity Assessment for IVD Medical
Devices.
13.2 Clinical performance studies using specimens from human subjects shall be
carried out in accordance with the spirit of the Declaration of Helsinki. This
includes every step in the clinical performance study from first consideration
of the need and justification of the study to publication of the results.