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IFU General Requirements
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20.1 IFUs shall be
provided through manufacturer website.
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20.1.(a) The medium,
format, content, legibility, and location of the label and instructions for
use shall be appropriate to the particular device, its intended purpose and
the technical knowledge, experience, education or training of the intended
user(s). In particular, instructions for use shall be written in terms
readily understood by the intended user and, where appropriate, supplemented
with drawings and diagrams.
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20.1.(e) Where multiple
devices, with the exception of devices intended for self-testing or
near-patient testing, are supplied to a single user and/or location, a single
copy of the instructions for use may be provided if so agreed by the
purchaser who in any case may request further copies to be provided free of
charge.
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20.1.(f) When the device
is intended for professional use only,instructions for use may be provided to
the user in non-paper format (e.g. electronic), except when the device is
intended for near-patient testing.
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20.1(g) Residual risks
which are required to be communicated to the user and/or other person shall
be included as limitations, contra-indications, precautions or warnings in
the information supplied by the manufacturer.
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20.1(i) Apply hazard
pictograms and labelling requirements of Regulation (EC) No 1272/2008.These
information shall be given in IFU when there is insufficient space to put all
the information on the device itself or on its label.
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23.1.(j) The provisions
of Regulation (EC) No 1907/2006 on the safety data sheet shall apply, unless
all relevant information, as appropriate, is already made available in the
instructions for use.
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IFU Content Requirements
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20.4.1(c)(i) What is
detected and/or measured
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20.4.1(c)(ii) function
(e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic)
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20.4.1(c)(iii) The
specific information that is intended to be provided in the context of:
—a physiological or
pathological state; —congenital physical or
mental impairments; —the predisposition to a
medical condition or a disease; —the determination of the
safety and compatibility with potential recipients; —the prediction of
treatment response or reactions; —the definition or
monitoring of therapeutic measures;
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20.4.1(c)(iv) automated
or not
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20.4.1(c)(v) qualitative,
semi-quantitative or quantitative
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20.4.1(c)(vii) testing
population
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20.4.1(c)(viii) For companion
diagnostics, the International Nonproprietary Name (INN) of the associated
medicinal product for which it is a companion test
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20.4.1(e) The intended user, as appropriate (e.g.
self-testing,near patient and laboratory professional use,healthcare
professionals)
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20.4.1(g) Description of
the calibrators and controls and any limitation upon their use (e.g. suitable
for a dedicated instrument only)
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20.4.1(h) Description of
the reagents and any limitation upon their use
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20.4.1(i) List of
materials provided and a list of special materials required but not provided
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20.4.1(j) combinations of
devices and equipment
· validated and safe combination, including key performance
characteristics, and/or
· known restrictions to combinations of devices and equipment
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20.4.1(m) Sterile devices
·
an indication of its sterile state ·
sterilisation method ·
instructions in the event of the sterile packaging being damaged before
use
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20.4.1(n)(i) Warnings,
precautions and/or measures to be taken in the event of malfunction of the
device or its degradation as suggested by changes in its appearance that may
affect performance,
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20.4.1(n)(ii) Warnings, precautions and/or measures to be taken as
regards the exposure to reasonably foreseeable external influences or
environmental conditions,such as magnetic fields, external electrical and electromagnetic
effects, electrostatic discharge, radiation associated with diagnostic
or therapeutic procedures, pressure, humidity, or temperature.(IVDD 8.7(r) ,Highligted
text added in IVDR)
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20.4.1(n)(iii) Warnings,
precautions and/or measures to be taken as regards the risks of
interference posed by the reasonably foreseeable presence of the device during
specific diagnostic investigations, evaluations, therapeutic treatment or
other procedures such as electromagnetic interference emitted by the device affecting
other equipment
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20.4.1(n)(iv) Precautions
related to materials incorporated into the device that contain or consist of
CMR substances, or endocrine disrupting substances or that could result in sensitisation
or an allergic reaction by the patient or user
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20.4.1(n)(v) Single use
devices
If the device is intended
for single use, an indication of that fact. A manufacturer’s indication of
single use shall be consistent across the Union
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20.4.1(n)(vi) Reusable
devices
·
If the device is reusable, information on the appropriate processes to
allow reuse, including cleaning, disinfection, decontamination, packaging
and, where appropriate, the validated method of resterilisation ·
Information shall be provided to identify when the device should no
longer be reused, such as signs of material degradation or the maximum number
of allowable reuses
(IVDD 8.7(q) ,Highligted
text added in IVDR)
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20.4.1(o) warnings and/or
precautions related to potentially infectious material that is included in
the device
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20.4.1(p) Requirements
for special facilities, such as a clean room environment.
special training, such as
on radiation safety, or particular qualifications of the intended user
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20.4.1(r) Details of any preparatory treatment or
handling of the device before it is ready for use, such as
sterilisation,final assembly, calibration, etc., for the device to
be used as intended by the manufacturer;(IVDD 8.7(o) ,Highligted
text added in IVDR)
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20.4.1(s) The information needed to verify whether the
device is properly installed and is ready to perform safely and as intended
by the manufacturer, together with, where relevant:/
—details of the nature,
and frequency, of preventive and regular maintenance, including cleaning and disinfection; —identification of any
consumable components and how to replace them; —information on any
necessary calibration to ensure that the device operates properly and safely during
its intended lifetime; —methods for mitigating
the risks encountered by persons involved in installing, calibrating or
servicing devices.
(IVDD 8.7(n) ,Highligted
text added in IVDR)
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20.4.1(u) The metrological traceability of values assigned to
calibrators and control materials, including identification of
applied reference materials and/or reference measurement procedures of higher
order and information regarding maximum (self-allowed) batch to batch
variation provided with relevant figures and units of measure;(IVDD 8.7(k)Point 2
,Highligted text added in IVDR)
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20.4.1(v) Assay procedure including calculations and
interpretation of results and where relevant if any confirmatory testing
shall be considered;where applicable, the instructions for use shall be accompanied
by information regarding batch to batch variation provided with relevant
figures and units of measure;(IVDD 8.7(g) ,Highligted
text added in IVDR)
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20.4.1(w) Analytical performance characteristics, such as analytical
sensitivity, analytical specificity, trueness (bias), precision
(repeatability and reproducibility),accuracy (resulting from trueness and
precision),limits of detection and measurement range,(information needed for
the control of known relevant interferences, cross-reactions and
limitations of the method), measuring range, linearity and information
about the use of available reference measurement procedures and materials by
the user;(IVDD 8.7(h)Point 2
,Highligted text added in IVDR)
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20.4.1(x) Clinical performance characteristics as defined in Section
9.1 of this Annex(IVDD 8.7(d),Highligted
text added in IVDR)
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20.4.1(z) Where relevant, clinical performance
characteristics, such as threshold value, diagnostic sensitivity and diagnostic
specificity, positive and negative predictive value
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20.4.1(ab) Information on
interfering substances or limitations (e.g. visual evidence of
hyperlipidaemia or haemolysis,age of specimen) that may affect the
performance of the device
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20.4.1(ac) Warnings or
precautions to be taken in order to facilitate the safe disposal of the
device, its accessories,and the consumables used with it, if any. This
information shall cover, where appropriate:(IVDD 8.7(s),Highligted
text added in IVDR)
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20.4.1(ac)(i) Infection
or microbial hazards, such as consumables contaminated with potentially
infectious substances of human origin
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20.4.1(ac)(ii) Environmental
hazards such as batteries or materials that emit potentially hazardous levels
of radiation)
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20.4.1(ac)(iii) Physical
hazards such as explosion
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20.4.1(ad) The name,
registered trade name or registered trade mark of the manufacturer and the
address of its registered place of business at which he can be contacted and
its location be established, together with a telephone number and/or fax
number and/or website address to obtain technical assistance(Detailed in IVDR)
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20.4.1(ae) Date of issue
of the instructions for use or, if they have been revised, date of issue
and identifier of the latest revision of the instructions for use, with a
clear indication of the introduced modifications(IVDD 8.7(u),Highligted
text added in IVDR)
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20.4.1(af) A notice to
the user that any serious incident that has occurred in relation to the
device shall be reported to the manufacturer and the competent authority of
the Member State in which the user and/or the patient is established
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20.4.1(ag) Where device
kits include individual reagents and articles that may be made available as
separate devices, each of these devices shall comply with the instructions
for use requirements contained in this Section and with the requirements of
this Regulation
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20.4.1(ah) For devices
that incorporate electronic programmable systems, including software, or
software that are devices in themselves, minimum requirements concerning hardware,
IT networks characteristics and IT security measures, including protection
against unauthorised access, necessary to run the software as intended.
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20.4.1(ah) Self-testing
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20.4.2(a) Details of the
test procedure shall be given, including any reagent preparation, specimen
collection and/or preparation and information on how to run the test and
interpret the results
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20.4.2(c) The device’s intended purpose shall provide sufficient information
to enable the user to understand the medical
context and to allow the intended user to make a correct interpretation of
the results;
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20.4.2(e) Information shall be provided with advice to the user on
action to be taken (in case of positive, negative or indeterminate result), on
the test limitations and on the possibility of false positive or false
negative result.
Information shall also be provided as to any factors that can affect
the test result such as age, gender,menstruation, infection, exercise,
fasting, diet or medication(IVDD 8.7(t) Point 1,Highligted text added in IVDR)
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20.4.2(f) The information provided shall include a statement clearly directing
that the user should not take any decision of medical relevance without first
consulting the appropriate healthcare professional, information on disease
effects and prevalence, and, where available, information specific to the
Member State(s) where the device is placed on the market on where a user can
obtain further advice such as national helplines, websites(IVDD 8.7(t) Point 3,Highligted text added in IVDR)
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