Clinical trials or performance evaluations
Information on submission of a request for authorisation of a clinical trial or a performance evaluation to the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with Section 22a of the German Act on Medical Devices
In accordance with Section 20 sub-section 1 of the German Act on Medical Devices ("Medizinproduktegesetz", MPG) as amended on 21 March 2010 (cf. Article 6 of the Law of 29 July 2009 (Bundesgesetzblatt [Federal Law Gazette] BGBl. I page 2326)), conducting clinical trials of medical devices and performance evaluations of In-vitro Diagnostic Devices (IVDD) requires authorisation by the competent federal higher authority ("Bundesoberbehörde"). ... further information
Information on submission of a request for waiving the authorisation of a clinical trial or a performance evaluation to the Federal Institute for Drugs and Medical Devices (Bundestinstitut für Arzneimittel und Medizinprodukte, BfArM) in accordance with Section 20 sub-section 1 sentence 2 of the German Act on Medical Devices
In accordance with Section 20 sub-section 1 sentence 2 of the German Act on Medical Devices ("Medizinproduktegesetz", MPG) the competent federal higher authority can waive the authorisation in case of clinical trials of medical devices with a low safety risk. In accordance with Section 24 MPG, the same applies to performance evaluations of low-risk in vitro diagnostic devices. ...further information
Scientific and Regulatory Advice through the BfArM
The objective of advice procedures is to discuss with the BfArM scientific and regulatory matters regarding the development and licensing of medicinal products and medical devices. In this context applicants have the opportunity to obtain input with regard to questions related to administrative procedures which are in the remit of the BfArM as competent authority. ...further information
Report form for reporting of serious adverse events (SAE) in clinical trials or performance evaluations for use by sponsors and investigators according to § 3 (5) of the Ordinance on Medical Devices Vigilance
Form (file size: 741 KB)
For further information (in German) please click here.