The instructions for use of the medical device and its marking shall consist of a set of information necessary for the safe and proper use of the device. It therefore applies accordingly to the General Directives relating to the type, form or presentation of the information on the device which is appropriate for its marking. In particular, this also applies to the prohibition of such a manual from misleading by including certain information in it. If it is not possible to pack each medical device separately, the information must appear in the leaflet accompanying one or more devices.
The packaging must contain instructions for use for each medical device. By way of exception, instructions for use may not be included in class I and IIa medical devices if they can be used safely without such instructions.
Instructions for use should include all the above-above information that also appears as part of the packaging marking (except for the code or batch or batch number and the date by which the medical device can be used safely). In addition, instructions for use must also include:
(1) performance parameters and any adverse reactions;
(2) where a medical device is to be installed or combined with other medical devices or equipment in order to operate in accordance with the intended use, particulars of its characteristics sufficient to correctly identify the medical devices or equipment in order to obtain a safe connection;
(3) necessary to verify that the medical device is properly installed and that it is functioning correctly and safely, and details of the type and frequency of maintenance and calibration necessary to ensure that the medical device always operates correctly and safely;
(4) to avoid the risks associated with implantation of a medical device, if applicable;
(5) information on the risk of interference with each other caused by the presence of the medical device in question during specific tests or treatments;
(6) the instructions necessary in the event of damage to the sterile packaging and details of the methods of re-sterilisation, if applicable;
(7) in the case of medical devices:
(a) for reusable use, information on the appropriate processes for re-use including cleaning, disinfection, packaging and the method of re-sterilisation of the medical device, if applicable, and restrictions on repeated use,
(b) instructions for sterilisation prior to use indicating the methods of operation after which the medical device will continue to comply with the requirements referred to in paragraph 1. 1-6 of the Regulation on essential requirements,
(c) labelled as single-use devices, information on known characteristics and technical reasons for the manufacturer making re-use risky; if, in accordance with point 2 above (Class I or IIa devices) instructions for use are not included in these devices, this information must be made available at the user's request;
(8) details of the procedures or proceedings necessary for the use of the medical device, in particular sterilisation or final assembly;
(9) in the case of medical devices emitting radiation for medical purposes, details of the type, type, intensity and distribution of radiation;
(10) any contraindications and precautions enabling healthcare professionals to take them and indunce them, in particular those referred to in paragraphs 11 to 17 below;
(11) precautions to be taken in the event of changes in the performance of the medical device;
(12) precautions to be taken to avoid exposure to magnetic fields, external electrical influence, electrostatic discharge, pressure or changes, acceleration, thermal ignition sources and other possible factors under foreseeable environmental conditions;
(13) the medicinal products or products for which the medical device is intended to be administered, including any restrictions on the choice of substances which may be administered;
(14) precautions to be taken in the event of unusual risks associated with getting rid of a medical device;
(15) medicinal substances or blood products forming an integral part of a medical device;
(16) the degree of accuracy declared for devices with a measuring function;
(17) the date of issue or the last update of the instructions for use.
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