# The Medical Devices Regulations 1994, Regulation 10: Procedure for affixing CE marking for Class III devices


A device falling within Class III may bear the CE marking only if its manufacturer—
(a) follows the EC declaration of conformity procedure (full quality assurance system) set out in Annex II; or
(b) follows the EC type-examination procedure set out in Annex III, together with—
(i) the EC verification procedure set out in Annex IV, or
(ii) the EC declaration of conformity procedure (production quality assurance) set out in Annex V.

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Source: https://www.legislation.gov.uk/uksi/1994/3017/regulation/10 (the official version)
Page: https://openlegislation.uk/medical-devices-regulations-1994/regulation-10
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.