# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.4

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

In addition, the notified body may pay unannounced visits to the manufacturer. At the time of such visits, the notified body may, where necessary, carry out or ask for tests in order to check that the quality system is working properly and that the production conforms to the requirements of the Directive which apply to it. To this end, an adequate sample of the final products, taken on site by the notified body, must be examined and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out. Where one or more of the samples fails to conform, the notified body must take the appropriate measures.
It must provide the manufacturer with an inspection report and, if a test has been carried out, with a test report.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VI/division/4/division/4.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VI/division-4/division-4.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.