# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 5

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

With products placed on the market in sterile condition and Class I devices with a measuring function, the manufacturer must observe not only the provisions laid down in this Annex but also one of the procedures referred to in Annex II, IV, V or VI. Application of the abovementioned Annexes and the intervention by the notified body is limited to:
in the case of products placed on the market in sterile condition, only the aspects of manufacture concerned with securing and maintaining sterile conditions,
in the case of devices with a measuring function, only the aspects of manufacture concerned with the conformity of the products with the metrological requirements.
Section 6.1. of this Annex is applicable.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/VII/division/5 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-VII/division-5
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.