# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 1.1c

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

The clinical evaluation and its documentation must be actively updated with data obtained from the post-market surveillance. Where post-market clinical follow-up as part of the post-market surveillance plan for the device is not deemed necessary, this must be duly justified and documented.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/X/division/1/division/1.1c (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-X/division-1/division-1.1c
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.