Regulation 17F Retention of documentation relating to performance studiesF1

(1)

The liquidator or trustee in bankruptcy of a sponsor of a performance study, or of a sponsor’s legal representative or contact person under Article 58(4), must—

(a)

retain for the required period any documentation that consists of, or reasonably could consist of, any of the documentation referred to in Annex XIV, 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 documentation relating to the performance study of a device that was subsequently placed on the market, 10 years after the last device was placed on the market;

(b)

in any other case, 10 years after the performance study ended.

Annotations

Textual amendments

F1: Pt. 3A inserted (21.3.2024) by The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 (S.I. 2024/221), regs. 1(2), 36