# 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 5.2

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 data stipulated in the part of the quality system relating to design, such as the results of analyses, calculations, tests, pre-clinical and clinical evaluation, post-market clinical follow-up plan and the results of the post-market clinical follow-up, if applicable, etc.,
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/2/division/5/division/5.2 (the official version)
Page: https://openlegislation.uk/eu-directive-1990-385/annex-2/division-5/division-5.2
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.