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PART IIAPPLICATION

Apparatus covered by other Directives

Active implantable medical devices

20.—(1) These Regulations do not apply to active implantable medical devices.

(2) In this regulation “active implantable medical device” has the meaning given by Article 1.2(c) of Council Directive 90/385/EEC (1) on the approximation of laws of the member States relating to active implantable medical devices.

(1)

OJ No. L189, 20.7.90, p.17.