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EU MDR Transition Recalls and market notifications Case studies and scenariosVersion 2.1, February 2024Therapeutic Goods Administration Copyright Commonwealth of Australia 2024 This work is copyright.
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What is extension of form mdr?
The extension of form MDR (Medical Device Reporting) is a mechanism that allows manufacturers and importers to report adverse events or product problems related to medical devices beyond the standard reporting period.
Who is required to file extension of form mdr?
Manufacturers, importers, and certain medical device user facilities are required to file for an extension of form MDR if they need additional time to gather information for reporting.
How to fill out extension of form mdr?
To fill out the extension of form MDR, you need to provide the reason for the extension request, your contact information, device details, and any supporting documentation that justifies the need for additional time.
What is the purpose of extension of form mdr?
The purpose of the extension of form MDR is to allow responsible parties more time to complete their investigation into the reported events, ensuring accurate and comprehensive reporting.
What information must be reported on extension of form mdr?
Information that must be reported includes the device name, the adverse event description, the reasons for requesting the extension, and expected timelines for completing the report.
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