Investigational Medical Device definition

Investigational Medical Device means the CE marked or non-CE marked study device(s) or control material(s) identified in the Clinical Investigation Plan.

Investigational Medical Device means the CE marked or non-CE marked study device(s) or control material(s) identified in the Clinical Investigation Plan; Investigator Site means the activities conducted under this Agreement and overseen by one Principal Investigator; Investigator Site File means the file maintained by the Principal Investigator containing the documentation specified in EN ISO 14155:2020; Investigator Site Investigation Completion means the conclusion of all Clinical Investigation Plan required activities for all enrolled Clinical Investigation Participants at the Investigator Site; Know-How means all technical and other information that is not in the public domain (other than as a breach of confidence) including, but not limited to, information comprising or relating to concepts, discoveries, data, designs, formulae, ideas, inventions, the IMD, methods, models, procedures, designs for experiments and tests and results of experimentation and testing, processes, specifications and techniques, laboratory records, clinical data, manufacturing data and information contained in submissions to Regulatory Authorities, whether or not protected by Intellectual Property Rights or any applications for such rights; Where the Principal Investigator has oversight of Study activities at the Trial Site and at an Other Trial Site(s), the Trial Site is the Lead Trial Site, being the ‘hub’ in a ‘hub and spoke’ trial site delivery model; Material [Delete if 4.16.10, 4.16.11 and Appendix 6 are not required] means any clinical biological sample, or portion thereof, derived from Clinical Investigation Subjects, including information related to such material, analysed by the Trial Site or Other Trial Site in accordance with the Clinical Investigation Plan, or otherwise supplied under Appendix 6 to the Sponsor or its nominee; MHRA means the Medicines and Healthcare products Regulatory Agency; MIA means the Master Indemnity Agreement that may be applicable in the part of the United Kingdom where the Trial Site is constituted;

Investigational Medical Device means a device, which is an object of a clinical investigation or research or development involving one or more subjects to determine the safety or effectiveness of a device;

Examples of Investigational Medical Device in a sentence

• Following analysis of data from the Clinical Investigation, in the event that the Sponsor decides not to CE Xxxx the Investigational Medical Device for the intended purpose being investigated, the Sponsor shall publish the analysis of the results within twenty four (24) months of the Clinical Investigation Completion Date.

• In the event that the Sponsor decides not to CE Xxxx the Investigational Medical Device for the intended purpose being investigated, the Sponsor may defer registration for up to twenty four (24) months after the Completion Date.

• Following analysis of data from the Clinical Investigation, in the event that the Sponsor decides not to CE Xxxx the Investigational Medical Device for the intended purpose being investigated, the Sponsor shall publish the analysis of the results within 24 months of the Clinical Investigation Completion Date.

• The Trust will not, and will ensure that the Investigator and Investigation Site Team Members do not, use the name of the Sponsor or Affiliate or of any of its employees, nor the name of the Clinical Investigation, nor the name of the Investigational Medical Device, in any publicity, advertising or news release without the prior written approval of the Sponsor, such approval not to be unreasonably withheld.

• The Board will not, and will ensure that the Investigator and Investigation Site Team Members do not, use the name of the Sponsor or Affiliate or of any of its employees, nor the name of the Clinical Investigation, nor the name of the Investigational Medical Device, in any publicity, advertising or news release without the prior written approval of the Sponsor, such approval not to be unreasonably withheld.

• If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in clause 4.3 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration.

• If, having considered all the circumstances, the Sponsor is of the view that the public interest benefits of registering the Clinical Investigation on the timescale specified in clause 4.2 are outweighed by the harm that registration at that time might do to the commercial value of the Investigational Medical Device or the commercial interests of the Sponsor, they may request the Health Research Authority (HRA) to authorise deferral of registration.

• The CRO expressly disclaims any liability in connection with the Investigational Medical Device caused by or allegedly caused by the use or misuse of the Investigational Medical Device other than liability for death, personal injury or loss of or damage to property which liability is the result of negligence on the part of the CRO.

• The Board will not, and will ensure that the Investigator and Investigation Site Team Members do not, use the name of the Sponsor or CRO or their Affiliates nor of any of their employees, nor the name of the Clinical Investigation, nor the name of the Investigational Medical Device, in any publicity, advertising or news release without the prior written approval of the Sponsor or CRO as appropriate, such approval not to be unreasonably withheld.

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More Definitions of Investigational Medical Device

Investigational Medical Device or “Test Medical Device” means medical device being assessed for safety or performance in a clinical investigation. ​

Investigational Medical Device means medical device being assessed for clinical performance, effectiveness, or safety in a clinical investigation.

Investigational Medical Device means a device, which is an object 15