# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 6.1

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

The application shall enable the design of the device to be understood and shall enable conformity with the design-related requirements of the directive to be assessed.
It shall include:
test reports including, where appropriate, results of studies carried out with lay persons,
data showing the handling suitability of the device in view of its intended purpose for self-testing,
the information to be provided with the device on its label and its instructions for use.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/III/division/6/division/6.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-III/division-6/division-6.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.