# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 3.1

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

For custom-made devices, documentation, indicating manufacturing site(s) and allowing an understanding of the design, manufacture and performances of the product, including the expected performances, so as to allow assessment of conformity with the requirements of this Directive.
The manufacturer must take all the measures necessary to ensure that the manufacturing process produces products which are manufactured in accordance with the documentation mentioned in the first paragraph;

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VIII/division/3/division/3.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VIII/division-3/division-3.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.