Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
Post Market Surveillance & Adverse Event Reporting What is an
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<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> <strong>an</strong>d <strong>Adverse</strong> <strong>Event</strong> reporting<strong>Post</strong> <strong>Market</strong> <strong>Surveill<strong>an</strong>ce</strong> – Activities of Competent Authoritiesof member states of the EU• Example : Germ<strong>an</strong>y BfArM – Bundesinstitut für Arzneimittelund Medzinprodukte- Overall responsible for the evaluation regarding the technical<strong>an</strong>d medical requirements <strong>an</strong>d the safety of medical devices- Shall adv<strong>is</strong>e the competent authorities within the federalstructure of Germ<strong>an</strong>y <strong>an</strong>d Germ<strong>an</strong> Notified Bodies.
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