# The Medical Devices Regulations 1994, Regulation 4: Classification of devices


(1) For the purposes of these Regulations, devices are classified into Classes I, IIa, IIb and III in accordance with the definitions, implementing rules and classification rules set out in Annex IX.
(2) In the event of a dispute between the manufacturer and a notified body resulting from the application of the definitions and rules referred to in paragraph (1), the matter shall be referred to the Secretary of State for decision.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/4 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-4
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.