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DAC6: Disclosure of crossborder arrangements HM Revenue and Customs Research Report 592 December 2019OFFICIALThe views in this report are the authors own and do not necessarily reflect those of HM
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Obtain the MDR UK disclosure of form from the relevant authority or website.
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Fill in the required information such as your name, contact details, and the details of the medical device in question.
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Manufacturers of medical devices operating in the UK are required to fill out the MDR UK disclosure of form.
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MDR UK disclosure is the reporting of medical device incidents and safety issues to the Medicines and Healthcare products Regulatory Agency.
Manufacturers, importers, and distributors of medical devices are required to file MDR UK disclosure.
MDR UK disclosure can be filled out online through the designated portal provided by the Medicines and Healthcare products Regulatory Agency.
The purpose of MDR UK disclosure is to ensure the timely reporting and investigation of safety issues related to medical devices.
Information such as the details of the incident, the medical device involved, any patient harm caused, and actions taken to address the issue must be reported on MDR UK disclosure.
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