# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 6.4

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

If the batch is accepted, the notified body affixes or has affixed its identification number to each product and draws up a written certificate of conformity relating to the tests carried out. All products in the batch may be put on the market except any in the sample which failed to conform.
If a batch is rejected, the competent notified body must take appropriate measures to prevent the batch from being placed on the market. In the event of frequent rejection of batches, the notified body may suspend the statistical verification.
The manufacturer may, on the responsibility of the notified body, affix the notified body's identification number during the manufacturing process.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/IV/division/6/division/6.4 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-IV/division-6/division-6.4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.