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Search results with tag "National competent authority"
Practical Guide - Europa
www.esma.europa.euThe Practical Guide has been compiled on the basis of information provided by National Competent Authorities under the Transparency Directive. Any queries regarding Member State specific content should be addressed directly to the relevant National Competent Authority in that Member State.
Vigilance Reporting - BSI Group
www.bsigroup.comMust Report - Trends . If a significant increase or trend of events or incidents that are usually excluded from individual reporting . The manufacturer should have suitable systems in place for proactive scrutiny of trends in complaints and incidents occurring with their devices - MedDev 2.12.1 . Report to National Competent Authority