The implementation of European Directives on Medical Devices (MDD), Active Implantable Medical Devices (AIMDD) and In-vitro Diagnostics (IVDD) into national law was previously accomplished by the Act on Medical Devices (“Medizinproduktegesetz”, MPG) in Germany. Due to the binding legal nature of the new European regulations, the transfer into the national law of each member country is no longer necessary. However, various national regulations are required, such as the determination of authority responsibilities. These were previously addressed by the MPG and must now be adapted to the requirements of the MDR and IVDR. In addition, each EU member state is free to supplement the European regulations at the national level with additional points not included in the regulation.
The Medical Device Law Implementation Act (“Medizinprodukterecht-Durchführungsgesetz”, MPDG) fulfills this task and replaces the MPG in Germany. Since 26th May 2021, the MPDG has been mandatory for manufacturers, operators and other stakeholders in Germany.
What is the MPDG?
In Germany, the MPDG is used to implement and supplement the European regulations MDR (EU/2017/745) and IVDR (EU/2017/746). The MPDG has an additional character at the national level and is not self-explanatory. Since it refers to the MDR at numerous points, both texts should be read in parallel.
What changes with the MPDG?
- Larger scope than the MPG
- Penalties have been expanded and intensified.
- There is no longer a Safety Officer (Medical Device Advisor remains).
- The chapter on clinical trials and performance evaluation has been expanded.
- Federal authorities will be involved in the future.