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

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

For custom-made devices or for devices intended for clinical investigations the manufacturer or his authorized representative established in the Community must draw up the statement containing the information stipulated in Section 2.

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