Division 5.1
United Kingdom
F1The manufacturer or his authorised representative must, for a period ending at least five years, and in the case of implantable devices at least 15 years, after the last product has been manufactured, make available to the national authorities:
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the declaration of conformity,
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the documentation referred to in the fourth indent of Section 3.1,
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the changes referred to in Section 3.4,
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the documentation referred to in the seventh indent of Section 3.1,
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the decisions and reports from the notified body as referred to in Sections 4.3 and 4.4,
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where appropriate, the type-examination certificate referred to in Annex III.