# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 6.2

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

A random sample is taken from each batch. The products which make up the sample are examined individually and the appropriate tests defined in the relevant standard(s) referred to in Article 5 or equivalent tests must be carried out to verify, where appropriate, the conformity of the products with the type described in the EC type-examination certificate and with the requirements of the Directive which apply to them in order to determine whether to accept or reject the batch.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IV/division/6/division/6.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-6/division-6.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.