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

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

The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.

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