# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 4.4

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

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 device. The applicant shall inform the notified body which issued the EC design-examination certificate of any such changes made to the approved design. The additional approval must 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/IV/division/4/division/4.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-IV/division-4/division-4.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.