8. Information supplied by the manufacturer
8.1. Each device must be accompanied by the information needed to use it safely
and properly, taking account of the training and knowledge of the potential
users, and to identify the manufacturer.
This information comprises the data on the label and in the instructions for
use.
As far as practicable and appropriate, the information needed to use the device
safely and properly must be set out on the device itself and/or, where appropriate,
on the sales packaging. If individual full labelling of each unit is not practicable,
the information must be set out on the packaging and/or in the instructions
for use supplied with one or more devices.
Instructions for use must accompany or be included in the packaging of one or
more devices.
In duly justified and exceptional cases no such instructions for use are needed
for a device if it can be used properly and safely without them.
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.
8.3. In the case of devices containing or a preparation which may be considered
as being dangerous, taking account of the nature and quantity of its constituents
and the form under which they are present, relevant danger symbols and labelling
requirements of Directive 67/548/EEC (2) and Directive 88/379/EEC (3) shall
apply. Where there is insufficient space to put all the information on the device
itself or on its label, the relevant danger symbols shall be put on the label
and the other information required by those Directives shall be given in the
instructions for use.
The provisions of the aforementioned Directives on the safety data sheet shall
apply, unless all relevant information as appropriate is already made available
by the instructions for use.
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.
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.
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.
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.
for complete copy of the Directive, click
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