# Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices, Division 5.1

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

In the case of devices covered by Annex II, List A, the manufacturer shall forward to the notified body without delay after the conclusion of the controls and tests the relevant reports on the tests carried out on the manufactured devices or each batch of devices. Furthermore, the manufacturer shall make the samples of manufactured devices or batches of devices available to the notified body in accordance with pre-agreed conditions and modalities.

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Source: https://www.legislation.gov.uk/eudr/1998/79/annex/VII/division/5/division/5.1 (the official version)
Page: https://openlegislation.uk/eu-directive-1998-79/annex-VII/division-5/division-5.1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.