# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.1

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

As a general rule, confirmation of conformity with the requirements concerning the characteristics and performances referred to in Sections 1 and 3 of Annex I, under the normal conditions of use of the device, and the evaluation of the side-effects and of the acceptability of the benefit/risk ratio referred to in Section 6 of Annex I, must be based on clinical data. The evaluation of this data, hereinafter referred to as ‘ clinical evaluation ’ , where appropriate taking account of any relevant harmonised standards, must follow a defined and methodologically sound procedure based on:

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