# The Active Implantable Medical Devices Regulations 1992, Paragraph 4: Approval and evaluation of quality system


(1) The notified body shall effect an evaluation of the quality system to determine whether it fulfils the conditions specified in paragraph 3(2) to (4), and in doing so shall presume fulfilment of those conditions for a quality system which is in accordance with relevant harmonized Standards.
(2) The team of individuals entrusted with the evaluation shall include at least one person who has already had experience of evaluations of the technology concerned.
(3) The evaluation shall include an inspection at the manufacturer’s premises.
(4) A decision as to whether or not approval is given shall be notified to the manufacturer after the final inspection and shall contain a reasoned evaluation and the conclusions of the notified body.

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Source: https://www.legislation.gov.uk/uksi/1992/3146/schedule/5/paragraph/4 (the official version)
Page: https://openlegislation.uk/active-implantable-medical-devices-regulations-1992/schedule-5/paragraph-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.