Retention of documentation relating to conformity assessments and custom-made devicesN.I.
This section has no associated Explanatory Memorandum
9.—(1) The liquidator or trustee in bankruptcy of a manufacturer, or of an authorised representative, must—
(a)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
(b)comply with any request made by the Secretary of State during the required period to provide the Secretary of State with the retained documentation.
(2) In this regulation, the required period is—
(a)in the case of information relating to an implantable device, 15 years after the last device was placed on the market, and
(b)in any other case, 10 years after the last device was placed on the market.
Commencement Information
I1Reg. 9 in force at 27.7.2021, see reg. 1(2)