Medical Devices Act Amendment (MPG) 2009

On March 21, 2010, an amendment to the Medical Devices Act (MPG) (Federal Law Gazette I No. 143/2009 of December 30, 2009) will come into force. Changes concern the reporting procedure for clinical trials with medical devices and the reporting obligations of adverse events.

Overview of the reporting procedures according to § 40 MPG BGBl. Nr. 657/1996 idF BGBl. I Nr. 143/2009 can be found as download.

Further inquiries:

Institute Inspections, Medical Devices & Hemovigilance

Doris Schweighofer

Tel.: +43 (0) 50 555-36430E-Mail: inspektionen@ages.atFurther information:

Forms "Clinical Investigation with Medical Devices" valid as of 21.03.2010.

Further inquiry note

basg@basg.gv.at