# The Medical Devices (Amendment) Regulations 2008, Regulation 12: Amendment of regulation 21 of the principal Regulations


In regulation 21 of the principal Regulations (scope of Part III)—
(a) the existing paragraph shall be numbered (1); and
(b) after paragraph 1 add—
“(2) Where a hazard exists, devices which are also machinery shall also meet the essential health and safety requirements set out in Annex I to that Directive to the extent to which those essential health and safety requirements are more specific than the essential requirements set out in Annex I to Directive 90/385.
(3) Where an active implantable medical device is intended to administer a medicinal product, that device shall be governed by Directive 90/385 without prejudice to the provisions of Directive 2001/83/EC.”.

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Source: https://www.legislation.gov.uk/uksi/2008/2936/regulation/12 (the official version)
Page: https://openlegislation.uk/medical-devices-amendment-regulations-2008/regulation-12
Contains public sector information licensed under the Open Government Licence v3.0. Source: legislation.gov.uk, The National Archives.