The new Medical Devices Operator Regulation (MPBetreibV 2025) has been in force since 20 February 2025. It brings with it far-reaching changes for operators of medical devices, which must be implemented by 31 July 2025 at the latest.

This article provides a practical overview of the changes and explains exactly what operators need to do now. We are also making two free documents available for download:

1. A checklist containing all the measures that must be implemented by July 2025.

2. A Word template for a maintenance plan – exclusively for users of our e-learning course.

Why an amendment to the MPBetreibV was necessary

Since the last amendment in 2017, the regulatory framework in the healthcare sector has changed significantly.

• Stricter regulatory requirements have been introduced through the EU MDR and IVDR.

• The increasing digitalisation and connectivity of medical devices heighten the risks of cyberattacks.

• Operators of medical devices need clear and practical rules to ensure patient safety.

The new Medical Device Operator Regulation therefore places greater emphasis on a holistic life-cycle management approach that takes into account the entire life cycle of a medical device – from procurement through to operation and decommissioning.

The key changes to the MPBetreibV 2025

1. Extended scope

The Regulation no longer applies solely to traditional medical devices, but to all products covered by the MPDG, including devices listed in Annex XVI of the MDR (e.g. cosmetic devices or EMS training equipment). A transition period until 31 July 2025 applies to these products.

Practical tip: Operators should now review their inventory list and also include devices that were not previously covered by the Operator Regulation.

2. New roles and responsibilities

The term ‘operator’ has been replaced by ‘user’. In addition, the role of the supplier has been introduced. This includes, for example, health insurance funds or medical supply shops, which, under certain conditions, assume the operator’s obligations.

Practical tip: Make it absolutely clear in contracts and agreements who bears the operator’s obligations.

3. Maintenance obligation – the cornerstone of the amendment

A central element of the new MPBetreibV is the maintenance obligation. Operators must demonstrate that they have an active maintenance plan. This includes:

• Visual inspections and cleaning by users

• regular maintenance in accordance with the manufacturer’s instructions

• safety inspections (STK)

• metrological checks (MTK)

• software updates and IT security measures

Failure to comply will result in fines in future.

Practical tip: Use digital maintenance software or an electronic equipment logbook to manage deadlines, test reports and maintenance records.

4. IT and cyber security

From 1 August 2025, operators must carry out an IT security audit for standalone software. This means that protection against tampering, data loss and cyber-attacks will be a legal requirement.

Practical tip: Carry out an IT risk assessment and document responsibilities for updates and patches.

5. Patient-owned devices

The amendment clarifies the handling of devices brought in by patients. Operators must ensure that these devices can be operated safely.

Practical tip: Develop a checklist for patient-owned devices (visual inspection, functional testing, documentation) and train your staff.

6. Life-cycle management rather than a focus on devices

The MPBetreibV will in future require proactive risk management: risks should be identified and controlled in advance, rather than only when damage has already occurred.

Practical tip: Carry out regular risk management reviews and integrate the results into your quality management system.

Our free resources for operators

To support medical device operators in implementing the new MPBetreibV, we have produced two practical documents:

✅ 1. MPBetreibV 2025 checklist

A concise overview of all measures that must be implemented by 31 July 2025.
👉 [Jetzt kostenlos herunterladen]

✅ 2. Maintenance Plan Template (exclusive to eLearning users)

A template setting out a complete maintenance plan for an active medical device in risk class IIa.
👉 [Exklusiv im eLearning verfügbar]

Conclusion

For medical device operators, the new MPBetreibV 2025 means:

• greater responsibility,

• more documentation requirements,

• but also greater clarity.

Anyone who introduces a systematic maintenance plan now, integrates IT security and defines clear responsibilities will be well-positioned for the future.

👉 Download our free checklist now and get a head start on implementation!