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Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (Text with EEA relevance)
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risks connected with the use of energy sources with particular reference, where electricity is used, to insulation, leakage currents and overheating of the devices,
risks connected with medical treatment, in particular those resulting from the use of defibrillators or high-frequency surgical equipment, and
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.
if applicable, the compatibility of the devices with the substances they are intended to administer, and
the reliability of the source of energy.
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