BMG is planning to allow off-label use (use outside the intended purpose) for medical devices
The Federal Ministry of Health (BMG) is planning to amend the Medical Devices Operator Ordinance (MPBetreibV) to allow off-label use (use outside the intended purpose) for medical devices.
Previously, Section 4 (1) of the MPBetreibV stipulated that medical devices may only be operated and used in accordance with their intended purpose. Use outside the intended purpose, i.e. off-label use, was therefore prohibited for medical devices.
At the beginning of November, the Federal Ministry of Health (BMG) published the draft bill for a third ordinance amending medical device regulations.
Among other things, Section 4 (1) MPBetreibV is to be deleted.
This will make off-label use of medical devices permissible in future.
The justification states:
"The operation and use [should] no longer be restricted by the specified purpose by statutory order. This serves to eliminate gaps in care in areas where, due to economic considerations on the part of manufacturers, little or no effort is made to develop and manufacture products (especially in the treatment of rare diseases and of newborns and children). The deletion of paragraph 1 is therefore urgently required in order to improve patient care while maintaining a high level of patient safety. On the one hand, this is ensured by the fact that, in accordance with paragraph 6, the user must ensure that a device is in good working order and in proper condition before using it and must observe the instructions for use and other accompanying safety-related information and maintenance instructions. On the other hand, due to the requirements in Regulation (EU) 2017/745 and Regulation (EU) 2017/746, it remains the case that changing the intended purpose of a product regularly requires compliance with manufacturer obligations, such as carrying out a conformity assessment procedure. At the same time, the deletion of paragraph 1 enables the "own manufacture" already provided for under European law in healthcare facilities in accordance with Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746."
The last sentence is not convincing. In-house manufacturing in accordance with Art. 5 (5) MDR is also possible without the deletion, as MDR provisions take precedence over a German ordinance. In addition, in-house manufacturing already existed under the MPG and MPV.
Off-label use has always been permitted for medicinal products. However, there are increased duties of care and information. In future, this will also apply to the off-label use of medical devices.