Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC)

15. When placed on the market, each device must be accompanied by instructions for use giving the following particulars: U.K.

• the year of authorization to affix the CE mark,

• the details referred to in 14,1 and 14.2, with the exception of those referred to in the eighth and ninth indents,

• the performances referred to in section 2 and any undesirable side effects,

• information allowing the physician to select a suitable device and the corresponding software and accessories,

• information constituting the instructions for use allowing the physician and, where appropriate, the patient to use the device, its accessories and software correctly, as well as information on the nature, scope and times for operating controls and trials and, where appropriate, maintenance measures,

• information allowing, if appropriate, certain risks in connection with implantation of the device to be avoided,

• information regarding the risks of reciprocal interference(1) in connection with the presence of the device during specific investigations or treatment,

• the necessary instructions in the event of the sterile pack being damaged and, where appropriate, details of appropriate methods of resterilization,

• 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 instruction leaflet must also include details allowing the physician to brief the patient on the contra-indications and the precautions to be taken. These details should cover in particular:

• information allowing the lifetime of the energy source to be established,

• precautions to be taken should changes occur in the device's performance,

• 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, etc.,

• adequate information regarding the medicinal products which the device in question is designed to administer[F1 ,]

• [F2 date of issue or the latest revision of the instructions for use.]

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).

(1)

‘Risks of reciprocal interference’ means adverse effects on the device caused by instruments present at the time of investigations or treatment, and vice versa.