Paragraph 15 Requirements as to design and construction
When placed on the market, each device must be accompanied by instructions for use giving the following particulars—
the year of authorisation to affix the EC mark;
the particulars specified in paragraph 14(1)(a) to (g) and (2)(c), (d) and (j);
the performances referred to in paragraph 2 and any undesirable side effects;
information allowing the registered medical practitioner to select a suitable device and the corresponding software and accessories;
information constituting the instructions for use allowing the registered medical practitioner and, where appropriate, the patient to use the device, its accessories and software correctly;
information on the nature of, and scope and times for, operating controls and trials;
where appropriate, information on maintenance measures;
information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided;
information regarding the risk of adverse effects on the device caused by instruments present at the time of specific investigations or treatment, and of adverse effects on instruments present at the time of those investigations or treatment caused by the device;
the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilisation; and
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 essential requirements.
The instructions shall also include details allowing the registered medical practitioner to brief the patient on the contra—indications and the precautions to be taken, including, in particular—
information allowing the lifetime of the energy source to be established;
precautions to be taken should changes occur in the device’s performances;
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, and similar influences; and
information identifying any medicinal products which the device in question is designed to administer.