Sch 1B Pt 10 para 6
The manufacturer shall, for a period ending 10 years after the instrument has been placed on the market, keep at the disposal of the market surveillance authorities: (a) the technical documentation referred to in paragraph 3.1, (b) the documentation concerning the quality system referred to in paragraph 3.1, (c) the information relating to the change referred to in paragraph 3.5, as approved; (d) the decisions and reports of the approved body referred to in paragraphs 3.5, 4.3 and 4.4.