# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.1

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

In addition to the obligations imposed by Section 3, the manufacturer must lodge with the notified body an application for examination of the design dossier relating to the product which he plans to manufacture and which falls into the category referred to in Section 3.1.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/II/division/4/division/4.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-II/division-4/division-4.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.