Investigational Device. The Sponsor/CRO, the Institution and the Principal Investigator agree to take all measures that might be required for lawful importation into the Czech Republic of all parts of the Device to be used in the Clinical Trials, including among other things obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan and that only the Principal Investigator or any Sub-Investigator(s) approved in writing by CRO/Sponsor shall use the Device. Institution and the Principal Investigator shall not, nor permit any third party to, attempt to alter, open, change or analyse, decompile, disassemble, reverse engineer (or the like) the Device. Institution shall keep traceability and accountability of all Devices. Institution and Principal Investigator will keep the Device in storage facilities in accordance with the CRO´s/Sponsor's instructions and with Applicable Laws, in particular Decree No. 62/2015 Coll., on Implementation of Certain Provisions of the Act on Medical Devices, as amended Should any Device be damaged for any reason, the Institution and Principal Investigator shall promptly return it to the Sponsor. Upon the earlier of, completion of all of the Clinical Trials and/or termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only. The Sponsor makes no warranties, express or implied, including and without limitation any of the implied warranties of merchantability, fitness for a particular purpose and non- infringement, regarding the Device. komisí a SÚKLem, a který obsahuje a uvádí v platnost všechny prvky uvedené v příslušném Plánu klinické zkoušky a veškeré další informace vyžadované Platnými právními předpisy.
Investigational Device. (a) Sponsor shall provide all Devices necessary for conduct of the Trial to the Clinical Team at no charge, pursuant to the terms set forth below and in the Agreement. The parties acknowledge that the Device is comprised of multiple components, including hardware, software, and disposables. The term “Device” refers to the hardware, software and/or disposables, as applicable. Hospital and Clinical Team shall not seek or retain payment from any patient, third-party health insurer or any other person or entity for the Device. (b) The volume of the Devices will be determined by mutual agreement of the parties and may be adjusted by them from time to time depending on usage patterns. Clinical Team will arrange for replacement of Devices as they are consumed by requesting replenishment materials from Sponsor as necessary. (c) The Devices shall be stored in a manner so as to afford ready inspection by Sponsor or its representative's at all reasonable times during normal business hours. The Devices shall be segregated and designated (by the posting of signs) as Sponsor's property, and as devices for use in the Trial only (d) Clinical Team shall not remove the Devices from their secured storage location, except to implant the Device during the Trial or to return the Device to Sponsor upon Sponsor's request. (e) Hospital and Clinical Team shall be 5. ZKUŠEBNÍ ZA ÍZENÍ. (a) Zadavatel poskytne Týmu klinické studie veškerá zařízení potřebná pro provedení Studie, a to bezplatně v souladu s podmínkami uvedenými níže a podmínkami uvedenými ve Smlouvě. Smluvní strany souhlasí, že Zařízení se skládá z několika součástí, včetně hardwaru, softwaru a jednorázových součástí. Pojmem „Zařízení“ se v závislosti na relevanci rozumí hardware, software a/nebo jednorázové součásti. Nemocnice a Tým klinické studie nebudou usilovat ani zadržovat úhradu za Zařízení od kteréhokoli pacienta, pojišťovny nebo jiného subjektu. (b) Množství Zařízení bude určeno vzájemnou dohodou mezi smluvními stranami a může být jimi upraveno v závislosti na vzorech používání. Tým klinické studie zajistí výměnu použitých Zařízení tak, že požádá Zadavatele v případě potřeby o doplňující materiál. (c) Zařízení musí být skladována takovým způsobem, aby byla možná jejich kontrola ze strany Zadavatele nebo jeho zástupců, a to v přiměřeném čase během běžné pracovní doby. Zařízení musí být oddělena a označena (olepena štítky) jako majetek Zadavatele a jako zařízení pro výhradní použití při Studii. (d) Tým klinické s...
Investigational Device. The Sponsor, the Institution and the Principal Investigator agree to take all measures required for lawful importation into the Czech Republic of all units of the Device to be used in the Clinical Trials, including obtaining all the necessary authorisation from the Czech customs authorities. The Institution and the Principal Investigator undertake not to use the Device other than as specifically stipulated in this Contract or the relevant Clinical Investigation Plan. Following completion of all of the Clinical Trials and termination or expiry of this Contract, or at the request of the Sponsor, all units of the Device currently held at the Institution shall be immediately returned to the Sponsor. The Principal Investigator shall notify the Sponsor immediately with regard to any defects or faults with respect to the Device. The Contracting Parties hereby note that the Device and all other materials and information provided under this Contract are of an experimental nature and are to be used for purposes of the Clinical Trials only. 1.4.
Investigational Device. The definition of an investigational device is a device that is assessed in a clinical investigation, MDR Article 2(46). An investigational device can be a non-CE marked device or a CE marked device. The definition does not differentiate between different regulatory statuses of devices. However, the reporting requirements are different depending on whether the clinical investigation is done for purposes described in Article 62, 74 or 82. The definition is understood to cover also the devices investigated in PMCF investigations, even if they are not subject to notification per Article 74.2.
Investigational Device. (LiquiBand FIX8®)
