# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 6.3

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

Statistical control of products will be based on attributes and/or variables, entailing sampling schemes with operational characteristics which ensure a high level of safety and performance according to the state of the art. The sampling schemes will be established by the harmonised standards referred to in Article 5, taking account of the specific nature of the product categories in question.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IV/division/6/division/6.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-6/division-6.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.