Regulation 15 Retention of documentation relating to clinical investigations

(1)

The liquidator or trustee in bankruptcy of a sponsor of a clinical investigation or of a sponsor’s legal representative or contact person under Article 62(2), 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 XV, 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 clinical investigation of a device that was subsequently placed on the market—

(i)

if the device was an implantable device, 15 years after the last device was placed on the market, and

(ii)

if the device was not an implantable device, 10 years after the last device was placed on the market;

(b)

in any other case, 10 years after the clinical investigation ended.