# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.1: Objectives

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

The objectives of clinical investigation are:
to verify that, under normal conditions of use, the performance of the devices conform to those referred to in Section 3 of Annex I, and
to determine any undesirable side-effects, under normal conditions of use, and assess whether they constitute risks when weighed against the intended performance of the device.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/2/division/2.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-2/division-2.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.