# Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC), Division 4.2

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

The manufacturer shall authorize the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:
the quality-system documentation,
the technical documentation,
the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardizations/calibrations and the qualifications of the staff concerned, etc.

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Source: https://www.legislation.gov.uk/eudr/1990/385/annex/5/division/4/division/4.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-5/division-4/division-4.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.