# The Active Implantable Medical Devices Regulations 1992, Paragraph 1


The manufacturer shall, before the start of manufacture, prepare and submit to the notified body documentation defining the manufacturing process, in particular as regards sterilisation, and all the routine, pre-established procedures to be implemented to ensure homogeneity of production and conformity of the devices with—
(a) the type described in the EC type-examination certificate; and
(b) the relevant requirements of the Directive.

---
Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/7/paragraph/1 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-7/paragraph-1
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.