13.6.Where appropriate, the instructions for use must contain the following particulars:U.K.
the details referred to in Section 13.3, with the exception of (d) and (e);
the performances referred to in Section 3 and any undesirable side-effects;
if the device must be 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 combination;
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 devices operate properly and safely at all times;
where appropriate, information to avoid certain risks in connection with implantation of the device;
information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment;
the necessary instructions in the event of damage to the sterile packaging and, where appropriate, details of appropriate methods of resterilization;
if the device is reusable, information on the appropriate processes to allow reuse, including cleaning, disinfection, packaging and, where appropriate, the method of sterilization of the device to be resterilized, and any restriction on the number of reuses.
Where devices are supplied with the intention that they be sterilized before use, the instructions for cleaning and sterilization must be such that, if correctly followed, the device will still comply with the requirements in Section I[F1.]
[F2If the device bears an indication that the device is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. If in accordance with Section 13.1 no instructions for use are needed, the information must be made available to the user upon request;]
details of any further treatment or handling needed before the device can be used (for example, sterilization, final assembly, etc.);
in the case of devices emitting radiation for medical purposes, details of the nature, type, intensity and distribution of this radiation.
Textual Amendments
F1 Substituted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
F2 Inserted by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (Text with EEA relevance).
The instructions for use must also include details allowing the medical staff to brief the patient on any contra-indications and any precautions to be taken. These details should cover in particular:
precautions to be taken in the event of changes in the performance of the device;
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.;
adequate information regarding the medicinal product or products which the device in question is designed to administer, including any limitations in the choice of substances to be delivered;
precautions to be taken against any special, unusual risks related to the disposal of the device;
[F1medicinal substances, or human blood derivatives incorporated into the device as an integral part in accordance with Section 7.4;]
degree of accuracy claimed for devices with a measuring function[F1;]
[F2date of issue or the latest revision of the instructions for use.]