# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 6.1

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

where this Annex is applied in conjunction with the procedure referred to in Annex IV, V or VI, the declaration of conformity referred to in the abovementioned Annexes forms a single declaration. As regards the declaration based on this Annex, the manufacturer must ensure and declare that the product design meets the provisions of this Directive which apply to it.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VII/division/6/division/6.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VII/division-6/division-6.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.