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

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

The manufacturer must allow the notified body access for inspection purposes to the inspection, testing and storage locations and supply it with all relevant information, in particular:
the documentation on the quality system,
the technical documentation,
the quality records, such as inspection reports, test data, calibration data, qualification reports of the staff concerned, etc.

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