Amendment of regulation 21 of the principal Regulations12
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.