# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 11.2.1

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

Where devices are designed to emit hazardous levels of radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks inherent in the emission, it must be possible for the user to control the emissions. Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/11/division/11.2/division/11.2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-11/division-11.2/division-11.2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.