In addition to Colette's points you also need to be aware of specific national regulations. For example you have the "Ordincance on clinical trials on medical devices" (translation by me, not official) where section 2 has some requirements on labelling. >> Have an eye on the provisions in the contract too: you should only be responsible for transportation/shipment of the devices and not for any approval (e.g. release approval). Responsibilities should be clearly stated in the contract between you and the sponsor. >> ISO 14155 states in section 9.2.2. c) that investigational devices shall not be made available to the sites until all requirements to start the clinical investigation are met. Provisions for device accountability are set out in section 7.9 in the ISO 14155.