# Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, Division 4.2

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

The manufacturer authorizes the notified body to carry out all the necessary inspections and must supply it with all relevant information, in particular:
the documentation on the quality system,
the technical documentation,
the data stipulated in the part of the quality system relating to manufacture, such as inspection reports and test data, calibration data, qualification reports of the personnel concerned, etc.

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Source: https://www.legislation.gov.uk/eudr/1993/42/annex/V/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1993-42/annex-V/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.