# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 6.3

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

The applicant shall inform the notified body which issued the EC design-examination certificate of any significant change made to the approved design. Changes to the approved design must receive further approval from the notified body which issued the EC design-examination certificate wherever the changes could affect conformity with the essential requirements of the Directive or with the conditions prescribed for use of the product. This additional approval shall take the form of a supplement to the EC design-examination certificate.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/III/division/6/division/6.3 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-III/division-6/division-6.3
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.