Medical Device Reporting Clause Samples

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), FMT is required to report to the applicable agency 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. Each of FMT and SST agree to supply to the other any such information promptly after becoming aware of it so that each of FMT and SST can comply with governmental reporting requirements. It is understood and agreed that reporting to FMT shall be within twenty-four (24) hours to enable FMT to comply with FDA reporting requirements. In the event that FMT is required by any regulatory agency to recall a Product, or if FMT or a regulatory authority initiates a Product recall, SST shall cooperate with and assist FMT in locating, and retrieving if necessary, recalled Product from SST's customers. Recalls initiated by FMT or by the FDA shall be at FMT's cost and expense. Except as described in the preceding sentence, SST and FMT shall share equally the costs and expenses of recalls initiated by a regulatory authority. SST shall maintain records of sales of Products by lot number and by end user to whom such Product was sold or otherwise transferred. Upon FMT's request, SST shall provide FMT with access to such records in the event of a Product recall or other quality related issue. SST shall be responsible for [*] - Certain information on this page has been omitted and filed separately with the Commission. Confidential treatment has been requested with respect to the omitted portion. obtaining all records of its sales to end users in the event of a Product recall or other quality related issue. During the time that the Products are commercially marketed, distributed, or sold by SST, SST also shall promptly forward all Product complaints which it received to FMT. SST shall make available to FMT for inspection SST's process and records for adverse event and other regulatory reporting purposes at mutually agreed upon times and further shall ensure that SST's processes comply with all applicable laws and regulations in the Territory.

Medical Device Reporting. Customer shall be solely responsible for reporting all medical device and malfunction reports as defined in 21 C.F.R. § 820, relating to the Product. To the extent ▇▇▇▇▇▇ Group has or receives any information regarding any medical device and malfunction report that may be related to the use of the Product, ▇▇▇▇▇▇ Group shall immediately, and in no event later than two (2) business days of receipt by ▇▇▇▇▇▇ Group, provide Customer with all such information. [*] = Portions of this exhibit have been omitted pursuant to a confidential treatment request. An unredacted version of this exhibit has been filed separately with the Commission.

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. 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. 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. M▇▇▇▇ is responsible for complying with all applicable FDA and foreign regulatory requirements pertaining to the reporting of adverse device events, including FDA’s Medical Device Reporting requirements, codified at 21 C.F.R Part 803. If D.7.1. Medtronic Obligations. Without limiting the generality of the foregoing, Medtronic shall: D.7.1.1. Maintain a Record of all customer and third-party complaints and reports of adverse events related to the Product(s), whether received orally or in writing. D.7.1.2. Medtronic will report to M▇▇▇▇ within two (2) business days when it suspects that one of M▇▇▇▇’▇ devices may have caused or contributed to a death or serious injury. M▇▇▇▇ will assess the event and provide Medtronic with its conclusions and justifications within the required regulatory timeframes. If M▇▇▇▇ and Medtronic agree that an adverse device event is reportable, then each company shall follow its own notification requirements as a manufacturer and distributor/importer, respectively, as required by law or regulation. If Medtronic disagrees with M▇▇▇▇, and believes that an adverse device event is reportable, then Medtronic will inform M▇▇▇▇ of its opinion in advance and follow Medtronic’s notification requirements as a distributor/importer as required by law or regulation. D.7.1.3. Establish a tracking system for all Product(s) so as to permit successful tracking in the event of a Recall; and D.7.1.4. Maintain Records and files of the complaints and reported adverse events.

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 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. ▇▇▇▇▇ is responsible for complying with all applicable FDA and foreign regulatory requirements pertaining to the reporting of adverse device events, including FDA’s Medical Device Reporting requirements, codified at 21 C.F.R Part 803. If Medtronic becomes aware of a potential MDR reportable event, notice of such event shall be given to ▇▇▇▇▇ within two (2) Business Days.