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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.
OJ No. L189, 20.7.90, p.17.