# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Article 3: Essential requirements

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

The devices must meet the essential requirements set out in Annex I which apply to them, taking account of the intended purpose of the devices concerned.
Where a relevant hazard exists, devices which are also machinery within the meaning of Article 2(a) of Directive 2006/42/EC of the European Parliament and of the Council of 17 May 2006 on machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to this Directive.

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