The MPDG has been the applicable regulatory framework since 26 May 2021 and replaces the Medical Devices Act (MPG). It was introduced to achieve alignment with the European MDR. The MPDG is therefore not an independent set of regulations but serves as a supplement to the MDR and is to be read complementarily at national level. When comparing the MPDG with the MDR, it is noticeable that the penalties are higher and there are more reasons for punishment. Examples are the unauthorised placing on the market of medical devices or commercial violations of the regulation.
For those familiar with the MPG, it might be interesting to know that the position of the safety officer for medical devices no longer exists and instead "the manufacturer" generally has the corresponding safety obligations. The control and monitoring of product performance in the market, on the other hand, has been expanded. For example, applying for, starting, conducting, and monitoring clinical trials has become much more complex and detailed.
