# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.2: Ethical considerations

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

Clinical investigations must be carried out in accordance with the Helsinki Declaration adopted by the 18th World Medical Assembly in Helsinki, Finland, in 1964, as last amended by the World Medical Assembly. It is mandatory that all measures relating to the protection of human subjects are carried out in the spirit of the Helsinki Declaration. This includes every step in the clinical investigation from first consideration of the need and justification of the study to publication of the results.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/2/division/2.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-2/division-2.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.