本页给出《MDR》Section 5的条文原文（摘自官方发布文本），并说明其含义与落到 PDF 文档上的处理要点。
of Annex IX shall apply with the proviso that any reference to an EU technical documentation assessment certificate shall be understood as a reference to an EU type-examination certificate. 7. Administrative provisions The manufacturer or, where the manufacturer does not have a registered place of business in a Member State, its authorised representative shall, for a period ending no sooner than 10 years, and in the case of implantable devices no sooner than 15 years, after the last device has been placed on the market, keep at the disposal of the competent authorities: — the documentation referred to in the second indent of Section 2, — information on the changes referred to in Section 5, and — copies of EU type-examination certificates, scientific opinions and reports and their additions/supplements.
本页条文为官方文本原文摘录，解释与文档建议基于该条文实际涉及的内容生成。条文引用以官方最新有效文本为准。
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