Information on submission of a request for waiving the authorisation of a clinical trial or a performance evaluation
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.
Since coming into force of the regulation in accordance with Section 20 sub-section 1 sentence 3 in conjunction with Section 37 sub-section 2a MPG stipulating details of the procedure, the BfArM applies the following principles. This publication is supposed to enable correct submission of the request thus facilitating an effective administrative procedure.
In order to initiate the procedure for waiving the authorisation of a clinical trial a corresponding request must be submitted to the BfArM.
The application is submitted electronically via the portal of the German Institute of Medical Documentation and Information (Deutsches Institut für Medizinische Dokumentation und Information, DIMDI: http://www.dimdi.de/static/de/mpg/ismp/kplp/index.htm). This procedure has the advantage that the documentation is available electronically thus facilitating the handling of supplements and variations.
Waiving of the authorisation of a clinical trial is possible in the following cases:
1. class I medical devices,
2. non-invasive class IIa medical devices,
3. medical devices that may bear a CE marking in accordance with Sections 6 and 10 MPG and the clinical trial of which would entail additional invasive or otherwise stressful examinations, unless this trial concerns a different intended purpose of the medical device,
4. In vitro diagnostic devices for which a performance evaluation in accordance with Section 24 sentence 1 numbers 1 and 2 MPG is intended.
A request for waiving the authorisation is to be accompanied by a consolidated risk evaluation as well as proof that a medical device or an in vitro diagnostic device as mentioned above under points 1 - 4 is concerned.
Proof of validation of the manufacturer's sterilisation procedures or statements regarding the reprocessing or sterilisation procedures to be performed by the trial site are also to be included for medical devices that are to be used in sterile condition.
Bonn, May 2010