Investigational Device Sample Clauses
The Investigational Device clause defines and governs the use of a medical device that is being tested or evaluated in a clinical study but has not yet received full regulatory approval. This clause typically outlines the device's intended use, restrictions on its distribution, and requirements for handling, monitoring, and reporting any issues or adverse events related to its use during the study. By clearly specifying these parameters, the clause ensures regulatory compliance and participant safety, while also clarifying the responsibilities of all parties involved in the research.
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. 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.
Investigational Device. 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.
Investigational Device. The definition of an investigational device is a device that is assessed in a clinical investigation, MDR Article 2
Investigational Device. (LiquiBand FIX8®)