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Med line International Germany GmbH Med line STR. 13 D47533 KleveChateaubriant 3rd December 2021URGENT: FIELD SAFETY NOTICE Medical Device Safety Advisory Notice ATTENTION: Pharmacist/Risk Manager
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Gather all relevant information about the safety issue that needs to be addressed in the notice.
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Urgent field safety notice is a report submitted to regulatory authorities regarding a safety concern with a medical device that requires immediate action.
Manufacturers, authorized representatives, and importers of medical devices are required to file urgent field safety notices.
Urgent field safety notices can be filled out electronically through the regulatory authority's online portal or submitted via mail.
The purpose of urgent field safety notice is to inform regulatory authorities of a safety issue with a medical device that poses a risk to patients.
Urgent field safety notices must include details of the safety issue, affected device models, actions taken to address the issue, and contact information for further inquiries.
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