Regulation 9 Retention of documentation relating to conformity assessments and custom-made devicesI1

retain for the required period any documentation that consists of, or reasonably could consist of, information to which section 8 of Annex IX applies, and

comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.

in the case of information relating to an implantable device, 15 years after the last device was placed on the market, and

in any other case, 10 years after the last device was placed on the market.