Regulation (EU) 2017/745 of the European Parliament and of the CouncilShow full title

19. Particular requirements for active implantable devices

19.1. Active implantable devices shall be designed and manufactured in such a way as to remove or minimize as far as possible:

(a)

risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,

(b)

risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and

(c)

risks which may arise where maintenance and calibration are impossible, including:

• excessive increase of leakage currents,

• ageing of the materials used,

• excess heat generated by the device,

• decreased accuracy of any measuring or control mechanism.

19.2. Active implantable devices shall be designed and manufactured in such a way as to ensure

• if applicable, the compatibility of the devices with the substances they are intended to administer, and

• the reliability of the source of energy.

19.3. Active implantable devices and, if appropriate, their component parts shall be identifiable to allow any necessary measure to be taken following the discovery of a potential risk in connection with the devices or their component parts.

19.4. Active implantable devices shall bear a code by which they and their manufacturer can be unequivocally identified (particularly with regard to the type of device and its year of manufacture); it shall be possible to read this code, if necessary, without the need for a surgical operation.