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IVD Essential Requirements Checklist
Manufacturer:
Device:
Date:
A. GENERAL
REQUIREMENTS
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No. |
Essential Requirement |
Applies?
(yes/no/na) |
Evidence of Compliance and Location;
Other
Remarks |
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1. |
The
device must be designed and manufactured in such a
way that, when used under the conditions and for the
purposes intended, they will not compromise,
directly or indirectly, the clinical condition or
the safety of patients, or the safety and health of
users or, where applicable, other persons, or the
safety of property. Any risks which may be
associated with their use must be acceptable when
weighed against the benefits to the patient and be
compatible with a high level of protection of health
and safety.
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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
manufacturer must apply the following principles in
the following order:
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eliminate or reduce risks as far as possible
(inherently safe design and
construction)
- where appropriate take adequate protection
measures including alarms if necessary, in relation
to risks that can not be eliminated.
- inform users of the residual risks due to
shortcomings of the protection measures adopted.
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3. |
The
devices must be designed and manufactured in such a
way that they are suitable for the purposes referred
to in Article 1(2)(b), as specified by the
manufacturer, taking account of the generally
acknowledged state of the art. They must achieve the
performances, in particular, where appropriate, in
terms of analytical sensitivity, diagnostic
sensitivity, analytical specificity, diagnostic
specificity, accuracy, repeatability,
reproducibility, including control of known relevant
interference, and limits of detection, stated by the
manufacturer.
The
traceability of values assigned to calibrators
and/or control materials must be assured through
available reference measurement procedures and/or
available reference materials of a higher order.
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No. |
Essential Requirement |
Applies?
(yes/no/na) |
Evidence of Compliance and Location;
Other
Remarks |
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4. |
The
characteristics and performance referred to in
sections 1 and 3 must not be adversely affected to
such a degree that the health or the safety of the
patients 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. When no lifetime is
stated, the same applies for the lifetime reasonably
to be expected of a device of that kind, having
regard to the intended purpose and the anticipated
use of the device.
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5. |
The
devices must be designed, manufactured and packed in
such a way that their characteristics and
performances during their intended use will not be
adversely affected during transport and storage
(temperature, humidity, etc.) taking into account
the instructions and information provided by the
manufacturer.
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B. DESIGN AND MANUFACTURING
REQUIREMENTS
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No. |
Essential Requirement |
Applies?
(yes/no/na) |
Evidence of Compliance and Location;
Other
Remarks |
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1.
1.1 |
Chemical
and Physical
The
devices must be designed and manufactured in such a
way as to achieve the characteristics and
performances referred to in Section A on the
“General Requirements”. Particular attention must be
paid to the possibility of impairment of analytical
performance due to incompatibility between the
materials and the specimens (such as biological
tissues, cells, body fluids and micro-organisms)
intended to be used with the device, taking account
of its intended purpose. |
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1.2 |
The
devices must be designed, manufactured and packed in
such a way as to reduce as far as possible the risk
posed by product leakage, contaminants and residues
to the persons involved in the transport, storage
and use of the devices, taking account of the
intended purpose of the product. |
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2.
2.1
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Infection and microbial contamination
The
devices and their manufacturing processes must be
designed in such a way as to eliminate or reduce as
far as possible the risk of infection to the user or
other persons. The design must allow easy handling
and, where necessary, reduce as far as possible
contamination of, and leakage from, the device
during use and, in the case of specimen receptacles,
the risk of contamination of the specimen. The
manufacturing processes must be appropriate for
these purposes. |
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No. |
Essential Requirement |
Applies?
(yes/no/na) |
Evidence of Compliance and Location;
Other
Remarks |
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2.2 |
Where a
device incorporates biological substances, the risks
of infection must be reduced as far as possible by
selecting appropriate donors and appropriate
substances and by using appropriate validated
inactivation, conservation, test and control
procedures.
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2.3 |
Devices
labelled either as ‘STERILE’ or as having a special
microbiological state must be designed, manufactured
and packed in an appropriate pack, according to
procedures suitable for ensuring that they remain in
the appropriate microbiological state indicated on
the label when placed on the market, under the
storage and transport conditions specified by the
manufacturer, until the protective packaging is
damaged or opened.
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2.4 |
Devices
labelled either as ‘STERILE’ or as having a special
microbiological state must have been processed by an
appropriate, validated method.
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2.5 |
Packaging
systems for devices other than those referred to in
section 2.3 must keep the product without
deterioration at the level of cleanliness indicated
by the manufacturer and, if the devices are to be
sterilised prior to use, reduce as far as possible
the risk of microbial contamination.
Steps
must be taken to reduce as far as possible microbial
contamination during selection and handling of raw
materials, manufacture, storage and distribution
where the performance of the device can be adversely
affected by such contamination.
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2.6 |
Devices
intended to be sterilized, must be manufactured in
appropriately controlled (e.g. environmental)
conditions.
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2.7 |
Packaging systems for non-sterile devices must keep
the product without deterioration in 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
sterilization indicated by the manufacturer.
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No. |
Essential Requirement |
Applies?
(yes/no/na) |
Evidence of Compliance and Location;
Other
Remarks |
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3
3.1 |
Manufacturing
and environmental properties
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 the use must be
indicated on the label or in the instructions for
use.
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3.2 |
Devices must be designed and
manufactured in such a way as to reduce as far as
possible the risks linked to their use in
conjunction with materials, substances and gases
with which they may come into contact during normal
conditions of use
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3.3 |
Devices
must be designed and manufactured in such a way as
to remove or reduce as far as possible:
— the risk of injury linked to their physical
features (in particular aspects of volume x
pressure, dimension and, where appropriate,
ergonomic features),
— risks linked to reasonably foreseeable external
influences, such as magnetic fields, external
electrical effects, electrostatic discharge,
pressure, humidity, temperature or variations in
pressure or acceleration or accidental penetration
of substances into the device.
Devices must be designed and
manufactured in such a way as to provide an adequate
level of intrinsic immunity of electromagnetic
disturbance to enable them to operate as intended.
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3.4 |
Devices must be designed and
manufactured in such a way as to reduce as far as
possible 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 or use in association with
flammable substances or substances which could cause
combustion.
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3.5 |
Devices must be designed and
manufactured in such a way as to facilitate the
management of safe waste disposal.
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3.6 |
The measuring, monitoring or display
scale (including colour change and other visual
indicators) must be designed and manufactured in
line with ergonomic principles, taking account of
the intended purpose of the device.
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No. |
Essential Requirement |
Applies?(yes/no/na) |
Evidence of Compliance and Location;
Other Remarks |
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4
4.1 |
Devices which
are instruments or apparatus with measuring function
Devices
which are instruments or apparatus having a primary
analytical measuring function must be designed and
manufactured in such a way as to provide adequate
stability and accuracy of measurement within
appropriate accuracy limits, taking into account the
intended purpose of the device and of available and
appropriate reference measurement procedures and
materials. The accuracy limits have to be specified
by the manufacturer. |
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4.2 |
When
values are expressed numerically, they must be given
in legal units conforming to the provisions of
Council Directive 80/181/EEC of 20 December 1979 on
the approximation of the laws of the Member States
relating to units of measurement.
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5
5.1 |
Protection
against radiation
Devices
shall be designed, manufactured and packaged in such
a way that exposure of users and other persons to
the emitted radiation is minimised.
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5.2 |
When
devices are intended to emit potentially hazardous,
visible and/or invisible radiation, they must as far
as possible be:
— 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,
— fitted with visual displays and/or audible
warnings of such emissions.
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5.3 |
The
operating instructions for devices emitting
radiation must give detailed information as to the
nature of the emitted radiation, means of protecting
the user, and on ways of avoiding misuse and of
eliminating the risks inherent in installation.
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6
6.1 |
Requirements
for medical devices connected to or equipped with an
energy source
Devices
incorporating electronic programmable systems,
including software, must be designed to ensure the
repeatability, reliability and performance of these
systems according to the intended use.
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6.2 |
Devices
must be designed and manufactured in such a way as
to minimise the risks of creating electromagnetic
perturbation which could impair the operation of
other devices or equipment in the usual environment.
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No. |
Essential Requirement |
Applies?(yes/no/na) |
Evidence of Compliance and Location;
Other Remarks |
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6.3 |
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
and maintained correctly. |
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6.4
6.4.1 |
Protection against mechanical and thermal risks
Devices
must be designed and manufactured in such a way as
to protect the user against mechanical risks.
Devices must be sufficiently stable under the
foreseen operating conditions. They must be suitable
to withstand stresses inherent in the foreseen
working environment, and to retain this resistance
during the expected life of the devices, subject to
any inspection and maintenance requirements as
indicated by the manufacturer.
Where there are risks due to the presence of moving
parts, risks due to break-up or detachment, or
leakage of substances, then appropriate protection
means must be incorporated.
Any guards or other means included with the device
to provide protection, in particular against moving
parts, must be secure and must not interfere with
access for the normal operation of the device, or
restrict routine maintenance of the device as
intended by the manufacturer.
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6.4.2 |
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.
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6.4.3 |
Devices
must be designed and manufactured in such a way as
to reduce as far as possible 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.
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6.4.4 |
Terminals
and connectors to electricity, gas or hydraulic and
pneumatic energy supplies which the user has to
handle must be designed and manufactured in such a
way as to minimise all possible risks.
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No. |
Essential Requirement |
Applies?(yes/no/na) |
Evidence of Compliance and Location;
Other Remarks |
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6.4.5 |
Accessible
parts of the devices (excluding the parts of areas
intended to supply heat or reach given temperatures)
and their surroundings must not attain potentially
dangerous temperatures under normal use.
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7 |
Requirements for devices for self-testing
appropriately for their intended purpose taking into
account the skills and the means available to users
and the influence resulting from variation that can
reasonably be anticipated in users’ technique and
environment. The information and instructions
provided by the manufacturer should be easily
understood and applied by the user. |
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7.1 |
Devices
for self-testing must be designed and manufactured
in such a way as to:
— ensure that the device is easy to use by the
intended lay user at all stages of the procedure,
and
— reduce as far as practicable the risk of user
error in the handling of the device and in the
interpretation of the results.
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7.2 |
Devices
for self-testing must, where reasonably possible,
include user control, i.e. a procedure by which the
user can verify that, at the time of use, the
product will perform as intended. |
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8
8.1 |
Information supplied by the manufacturer
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No. |
Essential Requirement |
Applies
(yes/no/na) |
Evidence of Compliance and Location;
Other Remarks |
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8.2 |
Where
appropriate, the information to be supplied should
take the form of symbols. Any symbol and
identification colour used must conform to the
harmonised standards. In areas for which no
standards exist, the symbols and colour used must be
described in the documentation supplied with the
device.
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8.4 |
The label
must bear the following particulars which may take
the form of symbols as appropriate:
a)
the name or trade name and address of
the manufacturer. For devices imported into the
Community with a view to their distribution in the
Community, the label, the outer packaging, or the
instructions for use shall contain in addition the
name and address of the authorised representative of
the manufacturer;
b)
the details strictly necessary for the
user to uniquely identify the device and the
contents of the packaging;
c)
where appropriate, the word ‘STERILE’
or a statement indicating any special
microbiological state or state of cleanliness;
d)
the batch code, preceded by the word
‘LOT’, or the serial number;
e)
if necessary, an indication of the
date by which the device or part of it should be
used, in safety, without degradation of performance,
expressed as the year, the month and, where
relevant, the day, in that order;
f)
in case of devices for performance
evaluation, the words ‘for performance evaluation
only’;
g)
where appropriate, a statement
indicating the in vitro use of the device;
h)
any particular storage and/or handling
conditions;
i)
where applicable, any particular
operating instructions;
j)
appropriate warnings and/or
precautions to take;
k)
if the device is intended for
self-testing, that fact must be clearly stated.
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8.5 |
If the
intended purpose of the device is not obvious to the
user, the manufacturer must clearly state the
intended purpose in the instructions for use and, if
appropriate, on the label.
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8.6 |
Wherever
reasonable and practicable, the devices and separate
components must be identified, where appropriate in
terms of batches, to allow all appropriate action to
detect any potential risk posed by the devices and
detachable components.
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8.7 |
Where
appropriate, the instructions for use must contain
the following particulars:
a)
the details referred to in section 8.4 with
the exception of points d) and e);
b)
composition of the reagent product by nature
and amount or concentration of the active
ingredient(s) of the reagent(s) or kit as well as a
statement, where appropriate, that the device
contains other ingredients which might influence the
measurement;
c)
the storage conditions and shelf life
following the first opening of the primary
container, together with the storage conditions and
stability of working reagents;
d)
the performances referred to in section 3 of
part A;
e)
an indication of any special equipment
required including information necessary for the
identification of that special equipment for proper
use;
f)
the type of specimen to be used, any special
conditions of collection, pre-treatment and, if
necessary, storage conditions and instructions for
the preparation of the patient;
g)
a detailed description of the procedure to be
followed in using the device;
h)
the measurement procedure to be followed with
the device including as appropriate:
— the principle of the method,
— the specific analytical performance
characteristics (e.g. sensitivity, specificity,
accuracy, repeatability, reproducibility, limits of
detection and measurement range, including
information needed for the control of known relevant
interferences), limitations of the method and
information about the use of available reference
measurement procedures and materials by the user,
— the details of any further procedure or handling
needed before the device can be used (for example,
reconstitution, incubation, dilution, instrument
checks, etc.),
— the indication whether any particular training is
required;
i)
the mathematical approach upon which the
calculation of the analytical result is made;
j)
measures to be taken in the event of changes
in the analytical performance of the device;
k)
information appropriate to users on:
— internal quality control including specific
validation procedures,
— the traceability of the calibration of the device;
l)
the reference intervals for the quantities
being determined, including a description of the
appropriate reference population;
m)
if the device must be used in combination
with or 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 and
proper combination;
n)
all the information needed to verify whether
the device is properly installed and can operate
correctly and safely, plus details of the nature and
frequency of the maintenance and calibration needed
to ensure that the device operates properly and
safely; information about safe waste disposal;
o)
details of any further treatment or handling
needed before the device can be used (for example,
sterilisation, final assembly, etc.);
p)
the necessary instructions in the event of
damage to the protective packaging and details of
appropriate methods of resterilisation or
decontamination;
q)
if the device is reusable, information on the
appropriate processes to allow reuse, including
cleaning, disinfection, packaging and
resterilisation or decontamination, and any
restriction on the number of reuses;
r)
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.;
s)
precautions to be taken against any special,
unusual risks related to the use or disposal of the
device including special protective measures; where
the device includes substances of human or animal
origin, attention must be drawn to their potential
infectious nature;
t)
specifications for devices for self-testing:
— the results need to be expressed and presented in
a way that is readily understood by a lay person;
information needs to be provided with advice to the
user on action to be taken (in case of positive,
negative or indeterminate result) and on the
possibility of false positive or false negative
result,
— specific particulars may be omitted provided that
the other information supplied by the manufacturer
is sufficient to enable the user to use the device
and to understand the result(s) produced by the
device,
— the information provided must include a statement
clearly directing that the user should not take any
decision of medical relevance without first
consulting his or her medical practitioner,
— the information must also specify that when the
device for self-testing is used for the monitoring
of an existing disease, the patient should only
adapt the treatment if he has received the
appropriate training to do so;
u)
date of issue or latest revision of the instructions
for use. |
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