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The Medical Devices Regulations 2002
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- UK Statutory Instruments
- 2002 No. 618
- PART III
- Regulation 25
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[F1UK marking of active implantable medical devices that come within the scope of this Part and other legislationE+W+S
25. Where a relevant device (within the meaning of this Part) comes within the scope of this Part and other product safety or health and safety legislation (“the other legislation”) a person must not affix a UK marking to the device unless the relevant requirements of the other legislation are also satisfied.]
Extent Information
E1This version of this provision extends to England and Wales and Scotland only; a separate version has been created for Northern Ireland only
Textual Amendments
F1Reg. 25 substituted (E.W.S.) (31.12.2020) by The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/791), regs. 1(1), 5(4B) (as amended by S.I. 2020/1478, regs. 1(3), Sch. 2 paras. 2, 26); 2020 c. 1, Sch. 5 para. 1(1)
CE marking of active implantable medical devices that come within the scope of more than one DirectiveN.I.
25. Where a relevant device comes within the scope of Directive 90/385 and another Directive (“the other Directive”) issued by one or more of the institutions of the Community, no person shall affix a CE marking to the device unless the relevant requirements of the other Directive are also satisfied, except where—
(a)the other Directive includes a provision allowing the manufacturer of the device to choose, during a transitional period that has not ended, which set of arrangements applies to it;
(b)the manufacturer chooses to follow the set of arrangements in Directive 90/385;
(c)the marking of the device indicates that the device only satisfies the set of arrangements chosen by the manufacturer; and
(d)the particulars of Directive 90/385, as published in the Official Journal of the [F2European Union], are given in the documents, notices or instructions accompanying the device, and in a manner in which those particulars are accessible without it being necessary to destroy the packaging which keeps the device sterile.
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E2This version of this provision extends to Northern Ireland only; a separate version has been created for England and Wales and Scotland only
Textual Amendments
F2Words in Regulations substituted (22.4.2011) by The Treaty of Lisbon (Changes in Terminology) Order 2011 (S.I. 2011/1043), arts. 2, 4 (with art. 3(3))
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