Update on the Medical Devices Operator Ordinance (MPBetreibV) and Medical Devices Dispensing Ordinance (MPAV)
25 February 2025
The Medical Devices Operator Ordinance (MPBetreibV) and the Medical Devices Dispensing Ordinance (MPAV) were recently amended and came into force on 20 February 2025, replacing the previous Medical Devices Operator Ordinance published on 21 August 21 2002 and last amended on 21 April 2021.
The MPBetreibV is a national German ordinance specifying requirements for the preparation, operation and use of medical devices and in-vitro diagnostics. The MPBetreibV regulates the dispensing of these products and contains provisions regarding prescription-only medical devices, pharmacy-only medical devices and other dispensing restrictions.
The update of the MPBetreibV and MPAV includes the following major changes:
- Extension of the application area as well as review and extension of definitions
- Reduction of documentation and testing requirements for low-risk products provided by health insurance companies
- Introduction of testing requirements for software with increased risk potential
- Removal of the dispensing restrictions for in-vitro diagnostics
- Specification of the existing regulations for the reprocessing of single-use devices
These changes serve to maintain patient safety in the healthcare sector and reflect the increasing importance of digitalization in this area.
