# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 12.1a

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

For devices which incorporate software or which are medical software in themselves, the software must be validated according to the state of the art taking into account the principles of development lifecycle, risk management, validation and verification.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/I/division/II/division/12/division/12.1a (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-I/division-II/division-12/division-12.1a
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.