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 in line with the principles of BS EN ISO 14155:2020; Investigator Site Investigation Completion means the conclusion of all Clinical Investigation Plan required activities for all enrolled 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; Lead Trial Site 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 4.17.10, 4.17.11 and Appendix 6 are not required] means any clinical biological sample, or portion thereof, derived from Participants, 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

• The Parties may only disclose Confidential Information to their own officers, Agents and employees (and in the case of the Sponsor, those of its Affiliates and, if applicable, other parties who may have contractual rights in the Results or to develop the Investigational Medical Device (for example, through a license, collaborative agreement, Co-Promotion Agreement, Co-Development Agreement, etc.

• 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 4.5 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.

• Until the Sponsor has obtained a letter of no objection from the MHRA (where the Clinical Investigation is a Regulated Clinical Investigation), a favourable opinion from the research ethics committee and any other necessary approvals, it shall not supply the Investigational Medical Device to the Trial Site.

• The Sponsor shall ensure that the Results of the Clinical Investigation are published on a free, publicly accessible clinical study results database within one (1) year after the Investigational Medical Device is first approved and made commercially available in any country or, if the Clinical Investigation is a Non-Regulated Clinical Investigation, within one (1) year of Clinical Investigation Completion.

• The provisions of this Clause 9.2 shall also apply to the Trial Site’s use of the name, trademark, service mark, and / or logo of any third parties collaborating with the Sponsor on the Clinical Investigation and / or the Investigational Medical Device (“Sponsor Collaborators”) provided that the Trial Site has been notified of the identity of the Sponsor Collaborators.

• The Trial Site shall ensure that neither administration of the Investigational Medical Device to any Clinical Investigation Participant nor any other clinical intervention arising from the Clinical Investigation Plan takes place in relation to any Clinical Investigation Participant until it is satisfied that all relevant approvals have been obtained.

More Definitions of Investigational Medical Device

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