# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 6.2

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

The notified body shall examine the application and, if the design conforms to the relevant provisions of this Directive shall issue the applicant 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 design-related requirements of the Directive. The certificate shall contain the conclusions of the examination, the conditions of validity, the data needed for identification of the approved design and, where appropriate, a description of the intended purpose of the product.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/III/division/6/division/6.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-III/division-6/division-6.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.