# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 4.3

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

The notified body must examine the application and, if the device conforms to the relevant provisions of the Directive, issue the application with an EC design-examination certificate. The notified body may require the application to be completed by further tests or proof to allow assessment of conformity with the requirements of the Directive. The certificate must contain the conclusions of the examination, the conditions of validity, the data needed for the identification of the approved design and, where appropriate, a description of the intended purpose of the device.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/IV/division/4/division/4.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-4/division-4.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.