Sch 1B Pt 11 para 7
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 documentation concerning the quality system referred to in paragraph 3.1, (b) the information relating to the change referred to in paragraph 3.5, as approved; (c) the decisions and reports of the approved body referred to in paragraphs 3.5, 5.3 and 5.4.