# The Medical Devices Regulations 1994, Regulation 23: Notification of decisions etc.


(1) Where a decision is taken by the Secretary of State or a notified body under these Regulations which results in the refusal of, or restrictions on, the placing on the market by, or the putting into service by, or the carrying out of clinical investigations by a person of a device, the Secretary of State who, or the notified body which, took the decision shall forthwith give to that person notice of the decision which shall include—
(a) a statement of the grounds on which it is based; and
(b) a statement of any legal remedies available to that person and of any time limits which apply to their exercise.
(2) The provisions of paragraph (1) are in addition to any more specific obligation placed upon the Secretary of State or the notified body elsewhere in these Regulations.
(3) Except in cases of emergency, the Secretary of State or a notified body which is considering making a decision referred to in paragraph (1), shall give the manufacturer or his authorised representative an opportunity to make representations to her or it (as the case may be) before the decision is taken.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/23 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-23
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.