# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 2.3.6

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

The investigations must be performed under the responsibility of a medical practitioner or another authorized qualified person in an appropriate environment.
The medical practitioner or other authorized person must have access to the technical and clinical data regarding the device.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/2/division/2.3/division/2.3.6 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-2/division-2.3/division-2.3.6
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.