# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.4: Active medical device

Extent: E+W+S+N.I.

Any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy. Medical devices intended to transmit energy, substances or other elements between an active medical device and the patient, without any significant change, are not considered to be active medical devices. Stand alone software is considered to be an active medical device.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IX/division/I/division/1/division/1.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IX/division-I/division-1/division-1.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.