ANNEX I – General safety and performance requirements

Chapter III (Part 2)

Requirements regarding the information supplied with the device

23.4. Information in the instructions for use

The instructions for use shall contain all of the following particulars:

(a)the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r)of Section 23.2;
(b)the device’s intended purpose with a clear specification of
indications, contra-indications, the patient target group or groups,
and of the intended users, as appropriate;
(c)where applicable, a specification of the clinical benefits to be
expected.
(d)where applicable, links to the summary of safety and clinical
performance referred to in Article 32;
(e)the performance characteristics of the device;
(f)where applicable, information allowing the healthcare professional
to verify if the device is suitable and select the corresponding
software and accessories;
(g)any residual risks, contra-indications and any undesirable side-
effects, including information to be conveyed to the patient in this
regard;
(h)specifications the user requires to use the device appropriately, e.g.
if the device has a measuring function, the degree of accuracy
claimed for it;
(i)details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final
assembly, calibration, etc., including the levels of disinfection
required to ensure patient safety and all available methods for
achieving those levels of disinfection;
(j)any requirements for special facilities, or special training, or
particular qualifications of the device user and/or other persons;
(k)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, and of any preparatory cleaning or disinfection,
— identification of any consumable components and how to replacethem,
— information on any necessary calibration to ensure that the
device operates properly and safely during its intended lifetime, and — methods for eliminating the risks encountered by persons
involved in installing, calibrating or servicing devices;
(l)if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use;
(m)if the device is supplied non-sterile with the intention that it is
sterilised before use, the appropriate instructions for sterilisation;
(n)if the device is reusable, information on the appropriate processes
for allowing reuse, including cleaning, disinfection, packaging and,where appropriate, the validated method of re-sterilisation
appropriate to the Member State or Member States in which the
device has been placed on the market. Information shall be
provided to identify when the device should no longer be reused,
e.g. signs of material degradation or the maximum number of
allowable reuses;
(o)an indication, if appropriate, that a device can be reused only if it is
reconditioned under the responsibility of the manufacturer to
comply with the general safety and performance requirements;
(p)if the device bears an indication that it is for single use, informationon known characteristics and technical factors known to the
manufacturer that could pose a risk if the device were to be re-used.This information shall be based on a specific section of the
manufacturer’s risk management documentation, where such
characteristics and technical factors shall be addressed in detail. If
in accordance with point (d) of Section 23.1. no instructions for use
are required, this information shall be made available to the user
upon request;
(q)for devices intended for use together with other devices and/or
general purpose equipment:
— information to identify such devices or equipment, in order to
obtain a safe combination, and/or
— information on any known restrictions to combinations of
devices and equipment;
(r)if the device emits radiation for medical purposes:
— detailed information as to the nature, type and where
appropriate, the intensity and distribution of the emitted radiation,
— the means of protecting the patient, user, or other person from
unintended radiation during use of the device;
(s)information that allows the user and/or patient to be informed of
any warnings, precautions, contra- indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any
warnings, precautions, contra-indications, measures to be taken and
limitations of use regarding the device. The information shall cover,where appropriate:
— warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may
affect safety,
— warnings, precautions and/ormeasures 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,
— 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,
or therapeutic treatment or other procedures such as
electromagnetic interference emitted by the device affecting other
equipment, — if the device is intended to administer medicinal
products, tissues or cells of human or animal origin, or their
derivatives, or biological substances, any limitations or
incompatibility in the choice of substances to be delivered,
— warnings, precautions and/or limitations related to the medicinal
substance or biological material that is incorporated into the device as an integral part of the device; and
— precautions related to materials incorporated into the device thatcontain or consist of CMR substances or endocrine-disrupting
substances, or that could result in sensitisation or an allergic
reaction by the patient or user;
(t)in the case of devices that are composed of substances or of
combinations of substances that are intended to be introduced into
the human body and that are absorbed by or locally dispersed in
the human body, warnings and precautions, where appropriate,
related to the general profile of interaction of the device and its
products of metabolism with other devices, medicinal products and
other substances as well as contra- indications, undesirable side-
effects and risks relating to overdose;
(u)in the case of implantable devices, the overall qualitative and
quantitative information on the materials and substances to which patients can be exposed;
(v)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:
— infection or microbial hazards such as explants, needles or
surgical equipment contaminated with potentially infectious
substances of human origin, and
— physical hazards such as from sharps.
If in accordance with the point (d) of Section 23.1 no instructions for use are required, this information shall be made available to the user upon request;
(w)for devices intended for use by lay persons, the circumstances in
which the user should consult a healthcare professional;
(x)for the devices covered by this Regulation pursuant to Article 1(2),
information regarding the absence of a clinical benefit and the risksrelated to use of the device;
(y)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;
(z)a notice to the user and/or patient that any serious incident that
has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the user and/or patient is established;
(aa)information to be supplied to the patient with an implanted device in accordance with Article 18;
(ab)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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