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Regulation 12 Amendment of regulation 21 of the principal Regulations

Original text. Later amendments are not shown.

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.”.