Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

National and International Information Exchange through Vigilance Reports

Bettina Missner (Abschlußjahr: 2004)

This essay deals with international and national information exchange through Vigilance Reports; its main focus is on European information exchange.

For that purpose, communication between the National Competent Authorities (NCAs) via Vigilance Reports in 2003 have been registered and evaluated.

The Federal Institute for Drugs and Medical Devices (BfArM) has granted access to the 230 Vigilance Reports that were issued in 2003 by the NCAs of the European Economic Area (EEA) and the NCAs participating in the Global Harmonization Task Force (GHTF) National Competent Authority Exchange Program.

For the evaluation the European legal requirements coming from the Medical Device Directive (MDD), the In Vitro Diagnostic Device Directive (IVDD) and the Active Implantable Medical Device Directive (AIMD) as well as the national legal requirements coming from the Medizinprodukte-Sicherheitsplan-Verordnung have been reviewed.

The requirements that follow from the Guidelines on a Medical Device Vigilance System (MEDDEV 2.12-1 rev 4) and the Guidance documents from the GHTF have also been taken into account.

Within the framework of the evaluation of the Vigilance Reports the various reporting practices in the different countries, the involvement of product categories and product classes in Vigilance Reports and special root causes for Vigilance Reports have been identified and discussed.

In summary, changes to the Vigilance System are necessary in order to guarantee the uniform application and interpretation of the Vigilance System. Even if differences in the different countries exist the system in place works appropriately and is useful to guarantee the efficiency and safety of devices.

Pages: 43