# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1

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

The EC declaration of conformity is the procedure whereby the manufacturer or his authorised representative who fulfils the obligations imposed by Section 2 and, in the case of products placed on the market in a sterile condition and devices with a measuring function, the obligations imposed by Section 5 ensures and declares that the products concerned meet the provisions of this Directive which apply to them.

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