As of 26.5.2021, new regulations apply to research on and with medical devices. These result from Article 62 and Article 82 of the Medical Device Regulation (Regulation (EU) 2017/745). The regulations for Germany can be found in §§ 3, 32-37 of the MPDG (Medical Devices Implementation Act).
Until then, the regulations of §§ 19 to 24 of the MPG apply: depending on the approval status, §§ 19 to 24 MPG apply to clinical trials of a medical device. The application to the Ethics Committee must be submitted electronically to the BfArM.
On this page you will find texts and templates for the information and consent of study participants, as well as further information. Please note that not all texts have yet been adapted to the GDPR.
Exceptions to the clinical trial according to § 23 MPG: In the clinical trial, a medical device bearing a CE marking is examined. In this context, the device must be used within the scope of its intended purpose, and no additional invasive or other stressful examinations may be carried out as a result of the study. These studies do not have to be submitted via the BfArM and are advised by the ethics committees according to § 15 of the professional regulations (“Other studies”).
Our texts and templates are until now only available in german. We are working hard to provide english translations as soon as possible.