# The Active Implantable Medical Devices Regulations 1992, Paragraph 4


The manufacturer shall authorise the notified body to carry out all necessary inspections and shall supply it with all appropriate information, in particular:
(a) the documentation relating to the quality system documentation;
(b) the data stipulated in the part of the quality system relating to manufacture, such as reports concerning inspections, tests, standardisations, calibrations, the qualifications of the staff concerned, etc.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/8/paragraph/4 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-8/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.