Regulation 10B Retention of documentation relating to conformity assessmentsF1
(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 7 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 10 years after the last device was placed on the market.
Annotations
Textual amendments
- F1
Pt. 2A inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 33