Application in accordance with the Medical Devices Implementation Act

Application in accordance with the Medical Devices Implementation Act (MPDG)

A clinical trial of medical devices or a performance study may only be started if the approval of the higher federal authority and the approving assessment of the responsible ethics committee have been obtained.

The application must be submitted electronically via the central registration system of the German Medical Devices Information and Database System (DMIDS).

Assistance, forms and samples can be found on the website of the Working Group of Medical Ethics Committees in the Federal Republic of Germany. We would particularly like to draw your attention to the

• Checklist for application documents for clinical trials and performance studies according to the MPDG,
• the checklist for investigator qualification/trial site suitability for clinical trials according to the MPDG
• as well as the sample information and consent forms.

Assessing the qualifications of examiners and deputies and evaluating the selection criteria of medical members of an examination group

In 2016, the German Medical Association published curricula on basic, advanced, refresher and update courses for investigators, deputies and members of review groups on the recommendation of the Working Group of Medical Ethics Committees and the Standing Conference (see here).
In addition, the Working Group of Medical Ethics Committees and the German Medical Association have drawn up recommendations for assessing the qualifications of investigators and deputies and for assessing the selection criteria for medical members of a review panel:
https://www.aerzteblatt.de/pdf.asp?id=204780

As an announcement of the German Medical Association, this document is highly binding and forms the basis for the decisions of the ethics committees in accordance with Section 40 (1) No. 5 AMG in conjunction with Section 42 (1) No. 2 AMG.
To illustrate this, we have summarized the requirements in a diagramsummarized.
It should be noted that the required medical qualification is assessed independently of this. The assessment is carried out in each individual case against the background of the specific clinical trial.

Fees

The consultation fees are based on the General Administrative Fee Schedule of the State of North Rhine-Westphalia. Section 5 fee item 2 of the Fee Schedule of the Ethics Committee of the Faculty of Medicine of the University of Cologne is thus superseded by higher-ranking law.