Common use of Medical Device Reporting Requirements Clause in Contracts

Medical Device Reporting Requirements. Subdistributor shall provide such assistance and information as Distributor and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor shall: (1) immediately transmit to Distributor all oral or written complaints regarding the Products that are received by Subdistributor; (2) keep and maintain a record of all customer complaints received by Subdistributor relating to the Products that are required to be maintained by Subdistributor pursuant to 21 C.F.R. § 803.18; (3) notify Distributor upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor and its Suppliers. It is the sole responsibility of Distributor and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territory. Notwithstanding the foregoing, in the event that Subdistributor is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor from doing so; provided, however, that Subdistributor shall immediately provide Distributor with prior notice of such reporting (to the extent legally permissible) and provide Distributor with copies of any such filings or reports (to the extent legally permissible).

Medical Device Reporting Requirements. Subdistributor Purchaser shall provide such assistance and information as Distributor Seller and/or its Suppliers reasonably request to comply with the Medical Device Reporting requirements set forth in 21 C.F.R. Part 803, as may be amended from time to time (the “MDR”), for the Products. Without limiting the generality of the foregoing, Subdistributor Purchaser shall: (1) immediately transmit to Distributor Seller all oral or written complaints regarding the Products that are received by SubdistributorPurchaser; (2) keep and maintain a record of all customer complaints received by Subdistributor Purchaser relating to the Products that are required to be maintained by Subdistributor Purchaser pursuant to 21 C.F.R. § 803.18; (3) notify Distributor Seller upon receipt of any information that indicates material safety concern with respect to the Products; and (4) otherwise cooperatively undertake investigations, provide information and analysis, and conduct such follow-up activities as reasonably requested by Distributor Seller and its Suppliers. It is the sole responsibility of Distributor Seller and/or its Suppliers to file Medical Device Reports, Vigilance Reports and other similar reports to any legal authority with respect to the Products in order to comply with the applicable laws and regulations of the Territoryregulations. Notwithstanding the foregoing, in the event that Subdistributor Purchaser is required by any applicable law or regulation to report medical device incidents, nothing in this Agreement shall prevent Subdistributor Purchaser from doing so; provided, however, that Subdistributor Purchaser shall immediately provide Distributor Seller with prior notice of such reporting (to the extent legally permissible) and provide Distributor Seller with copies of any such filings or reports (to the extent legally permissible).