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MDD

Vigilance in EU MDR

Introduction The Medical Device Vigilance System’s goal is to lower the risks of using medical equipment and serious incidents while it strives to improve protection for patients, healthcare providers, and other users. A National Competent Authority Report is one way that adverse occurrences are evaluated and, where necessary, information is shared according to the Medical Devices Directives/Regulations (NCAR). The implementation of suitable field safety corrective measures aims to prevent...
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Safety Reporting on Clinical investigation

Under EU MDR 2017/245 Article 73, the sponsor shall report to all member states about the clinical investigations undertaken by the medical devices through an electronic system in case of any serious adverse events, device deficiency which leads to adverse events or any novel findings with regards to the event. The submission period may vary depending on the severity of the events. An initial incomplete report followed by the complete report shall be provided.  The reporting procedures are...
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Technical Documentation Requirements MDD Vs MDR

Check out the difference between MDD vs MDR MDD vs MDR MDD A MDD Technical documentation must include: MDR All Technical documentation requirements of MDD must be presented for the MDR alongside the below additional list: Device Description and Specifications Information to be supplied by the manufacturer Design and Manufacturing Information General Safety and Performance Requirements Benefit-Risk Analysis and Risk Management The benefit-risk analysis, the solutions adopted, and the results of t...
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