At the same time, the MPBetreibV in the version published on 21.08.2002 (BGBl. I p. 3396), which was last amended by Art. 7 of the regulation of 21.04.2021 (BGBl. I p. 833), will expire. Simultaneously, the First Amendment Regulation of the MPBetreibV was promulgated, which also comes into force on 20.02.2025.
A. Background
The first draft bill to revise the MPBetreibV was submitted to the Federal Council in May 2024 and adopted in July 2024 with additional amendments. The Federal Council’s decision completely changed the new regulation on the reprocessing and reuse of single-use devices that the BMG was aiming for. The BMG originally wanted to include two reprocessing procedures intented by the EU and subject to approval at national level in the regulation. However, the Federal Council’s decision only included one of these procedures.
As a result, the BMG decided not to promulgate the regulation for the time being and prepared a new draft bill to amend the (yet to be promulgated) new version of 07.10.2024. This draft bill included a revision of Sec. 9 on the reprocessing of single-use devices and was again submitted to the federal states and interest groups for comment.
The new version and the amending regulation were finally submitted to the Federal Council for a vote on 14.02.2025.
The new version of the MPBetreibV meets the increased requirements for digital medical devices and now also takes into account risky software products. At the same time, the documentation and testing requirements for low-risk products are reduced.
When reading the new version, it should be noted that the First Amendment of the MPBetreibV, which was announced at the same time, repeals the ban on the use of single-use devices reprocessed in accordance with Art. 17 para. 2 MDR on humans in the same legal second and regulates the reprocessing and reuse of single-use devices by healthcare facilities in accordance with the legal situation that already applied.
B. Innovations
The changes affect key areas of the MPBetreibV in different ways.
I. Definitions (Sec. 2)
In the new version of the MPBetreibV, the terms “user” and “provider” are defined for the first time:
- “User” is anyone who uses a device on a patient.
- “Provider” is anyone who has to provide products to the patient on the basis of a legal or contractual obligation.
II. General requirements (Sec. 4)
Sec. 4 para. 3 has been supplemented by a special obligation to provide instruction on software. Now there is an obligation to provide instruction not only when using software for the first time, but also after each installation or update of software, provided that this changes the handling by the user not only slightly.
III. Reprocessing and reuse of single-use devices (Sec. 9)
While in the old version of the MPBetreibV, reprocessing was generally regulated in Sec. 8, there is now a differentiation between general medical devices and single-use devices in Sec. 8 and 9. While the new version provided for a ban on the use of single-use devices reprocessed in accordance with Art. 17 para. 2 MDR on humans, the First Amendment immediately returns to the old legal framework of Sec. 8 para. 4 to para. 7 MPBetreibV and incorporates this into the new Sec. 9 MPBetreibV. According to Sec. 9 MPBetreibV in the version of the First Amendment, the reprocessing and reuse of single-use devices by healthcare facilities remains permissible in accordance with the requirements of Art. 17 para. 3 MDR and the common specifications issued in accordance with Art. 17 para. 5 MDR.
IV. Safety checks (Sec. 12)
One of the key changes concerns the safety checks (STK) for automatic external defibrillators (AED). These are no longer required if the AED has a self-test function, and a regular visual inspection is carried out by the operator.
V. Special obligations for certain software (Sec. 17)
Sec. 17 was newly introduced, which regulates special obligations for the operation of software as a class IIb and III medical device. Operators must ensure that the software is properly installed and that users are instructed in the proper handling and operation of the software. However, this regulation does not come into force until August 1, 2025 in accordance with Sec. 20 para. 3 of the new version of the MPBetreibV.
Do you have any questions about this news or would you like to discuss it with the author? Please contact: Dr. Boris Handorn and Anna Christ
