# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.3.5

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

All serious adverse events must be fully recorded and immediately notified to all competent authorities of the Member States in which the clinical investigation is being performed.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/2/division/2.3/division/2.3.5 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-2/division-2.3/division-2.3.5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.