# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Article 3

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

The active implantable medical devices referred to in Article 1(2)(c), (d) and (e), hereinafter referred to as ‘ devices ’ , shall satisfy the essential requirements set out in Annex 1 which apply to them, account being taken 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 1 to this Directive.

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Source: https://www.legislation.gov.uk/eudr/1990/385/article/3 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/article-3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.