# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.1.1

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

Either a critical evaluation of the relevant scientific literature currently available relating to the safety, performance, design characteristics and intended purpose of the device, where:
there is demonstration of equivalence of the device to the device to which the data relates, and
the data adequately demonstrate compliance with the relevant essential requirements.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/1/division/1.1/division/1.1.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-1/division-1.1/division-1.1.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.