Medical Device Reporting. Pursuant to governmental medical device ------------------------ reporting regulations (e.g. the FDA's Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), TheraSense is required to report to the applicable agency information that reasonably suggests that a FreeStyle Product may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. Each of TheraSense and Disetronic agree to supply to the other any such information promptly after becoming aware of it so that each of TheraSense and Disetronic can comply with governmental reporting requirements. It is understood and agreed that reporting to TheraSense shall be within twenty-four (24) hours to enable TheraSense to comply with FDA reporting requirements. Disetronic agrees to use its best efforts to promptly retrieve and return to TheraSense any individual FreeStyle Product which Disetronic has reported to TheraSense or a governmental agency. In the event that TheraSense is required by any regulatory agency to recall a FreeStyle Product, or if TheraSense or a regulatory authority initiates a FreeStyle Product recall, Disetronic shall cooperate with and assist TheraSense and its Authorized Representative in locating, and retrieving if necessary, recalled FreeStyle Products from Customers. Recalls shall be at Disetronic's cost and expense in the European Territory and at TheraSense's cost and expense in the U.S. Territory. Notwithstanding the foregoing, in the event that a recall is primarily due to a FreeStyle Product manufacturing defect then TheraSense shall provide to Disetronic replacement FreeStyle Product at no charge. Disetronic shall maintain records of sales of -18- Initials ____ ____ *** CONFIDENTIAL TREATMENT REQUESTED FreeStyle Products by lot number and by end user to whom such product was sold or otherwise transferred. Upon TheraSense's request, Disetronic shall provide TheraSense with access to such records in the event of a FreeStyle Product recall or other quality related issue. Disetronic shall be responsible for obtaining all records of its sales to end users in the event of a FreeStyle Product recall or other quality related issue. Disetronic shall make available to TheraSense for inspection Disetronic's process and records for adverse event and ...
Medical Device Reporting. Should Stellartech become aware of any information relating to product function and/or safety that may be reportable to US FDA under 21 CFR Part 803 (Medical Device Reporting) or to a member of the EEA under MDD Vigilance such information shall be reported to Thermage immediately. In Section 7 of the Development and Supply Agreement, Section 7.4 is added to read in its entirety as follows:
Medical Device Reporting. Purchaser shall be responsible to report events in compliance with FDA Medical Device Reporting Regulation set forth in 21 CFR Part 803 and any applicable international regulations. Purchaser agrees to make Medical Device Reports available to Supplier within three (3) days of the initial receipt of any report that reasonably suggests that one of the Products (i) may have caused or contributed to a death or serious injury or (ii) has malfunctioned.
Medical Device Reporting. The Party that is considered the legal manufacturer shall be responsible for reporting to the relevant Regulatory Agency and/or FDA all Complaints and Adverse Events relating to the Product that are required to be reported under FDA medical device reporting regulations, 21 CFR Part 803, as amended.
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Product, and VTAL shall be primarily responsible for evaluation of any reportable incidents that relate to the VTAL Workstation. Each of R2 and VTAL agree to supply to the other any information relating to such reportable incident promptly after becoming aware of it so that each of R2 and VTAL can comply with governmental reporting requirements.
Medical Device Reporting. Pursuant to governmental medical device reporting regulations (e.g. the FDA’s Medical Device Reporting (MDR) Regulations, the European Medical Device Vigilance Guidelines, and any other applicable medical device reporting regulations), the parties may be required to report to the applicable agency information that reasonably suggests that the products contemplated hereunder may have caused or contributed to the death or serious injury or have malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. R2 shall be primarily responsible for evaluating any such reportable incidents that relate to the R2 Lung CAD Product. Each of R2 and Vital agree to supply to the other any information relating to such reportable incidents promptly after becoming aware of them so that each of R2 and Vital can comply with governmental reporting requirements.
Medical Device Reporting. The Parties agree to comply with and be responsible for reporting all MDR Reportable Events to each other within [***] business days of becoming aware of same and agree to comply with all procedures established by Distributor, in accordance with all Applicable Laws in connection with the tracking and reporting of MDR Reportable Events. Distributor alone is responsible for investigating and reporting to the FDA all MDR Reportable Events.
Medical Device Reporting. Pursuant to the FDA’s and other European and foreign applicable Medical Device Reporting regulations, if either Party is required to report to the FDA or European notified bodies information that reasonably suggests that a Product may have caused or contributed to the death or serious injury or has malfunctioned and that the device would be likely to cause or contribute to a death or serious injury if the malfunction were to recur then each of VC and GEHC agree to supply to the other any such information promptly after becoming aware of it so that each of VC and GEHC can comply with governmental reporting requirements. Each Party will use commercially reasonable efforts to comply with all applicable 26/39 governmental reporting. Subject to Section 4.1, in the event that VC is required by any regulatory agency to recall a Product, or if VC or a regulatory authority initiates a Product recall, GEHC will cooperate with and assist VC in locating, and retrieving if necessary, the recalled Products from GEHC’ End Users. All recalls of the Products arising from manufacture defects will be at VC’s cost and expense.
Medical Device Reporting. For the purposes of medical device reporting per Title 21 part 803 of the Code of Federal Regulations, Suneva shall be considered a distributor (per 21 CFR § 803.3(g)) of the Products. As such, Suneva acknowledges the requirements set forth for a distributor under 21 CFR part 803, including requirements regarding complaint records.
Medical Device Reporting. The Reseller shall provide Todos with reports of any adverse events and product problems in accordance with the Mandatory Medical Device Reporting regulations of 21 CFR 803.
