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URGENT FIELD SAFETY NOTICE
Field Safety Corrective Action:
Commercial Name:Rocket FBS AmnioscopesAffected Product Codes:See tablet:Type of action:Advocate of Notice:29th July, 2019Reference:CUSTOCC144Use
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What is mdr - article 89?
Article 89 of the Medical Device Regulation (MDR) establishes requirements for reporting serious incidents and field safety corrective actions by manufacturers and other economic operators.
Who is required to file mdr - article 89?
Manufacturers, authorized representatives, importers, and distributors of medical devices are required to file MDR - Article 89 reports.
How to fill out mdr - article 89?
MDR - Article 89 reports should be filled out online through the relevant national competent authority's designated electronic system according to the specific reporting requirements set out in the regulation.
What is the purpose of mdr - article 89?
The purpose of MDR - Article 89 is to ensure the timely reporting of serious incidents and field safety corrective actions related to medical devices to protect public health and safety.
What information must be reported on mdr - article 89?
Information such as details of the incident, affected devices, affected patients, actions taken, and any updates must be reported on MDR - Article 89.
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