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Operator duties for medical devices under the MPBetreibV

Overview for hospitals, practices and care facilities · As of October 2026

Anyone who uses medical devices in a healthcare facility is responsible, as the operator, for operating them safely. The basis is the German Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung, MPBetreibV). It was fundamentally revised in 2025 and the new version came into force on 20 February 2025. This overview reflects the legal position as of October 2026 and shows which duties follow from it in everyday work.

In this guide, “operator” refers to the person or organisation legally responsible for operating the healthcare facility or device under the MPBetreibV. It does not mean the individual user of the device.

Who is the operator?

Who the operator is follows from §§ 2 and 3 MPBetreibV. In healthcare facilities this is, in principle, the natural or legal person responsible for running the facility. Special rules apply to devices that are made available or brought in by others.

The main duties at a glance

• Instruction (Einweisung): Users must in principle be instructed in the proper handling of the device. For active non-implantable devices the instruction must be documented in a suitable form (§ 4 MPBetreibV). For devices listed in Annex 1, stricter requirements for the functional test and instruction apply (§ 11 MPBetreibV).
• Maintenance: This covers in particular necessary servicing and inspections as well as repairs to restore functionality. The manufacturer's information must be taken into account. For software, safety-relevant software updates are included (§ 7 MPBetreibV).
• Reprocessing: Devices that are intended to be used with a reduced microbial load or in a sterile condition must be reprocessed in line with the manufacturer's information using suitable validated procedures whose success is demonstrably ensured. Special requirements apply to the reprocessing and reuse of single-use devices (§§ 8 and 9 MPBetreibV).
• Safety inspections (STK, sicherheitstechnische Kontrollen): For devices listed in Annex 1, safety inspections must in principle be carried out no later than every two years, in accordance with the generally recognised rules of technology (allgemein anerkannte Regeln der Technik). If defects are to be expected sooner because of the actual conditions of use and environment, the inspections must take place correspondingly earlier. These requirements apply accordingly to other devices and to items connected to Annex 1 devices (§ 12 MPBetreibV).
• Metrological controls (MTK, messtechnische Kontrollen): For devices listed in Annex 2, metrological controls must be carried out within the deadlines set there. The deadlines differ by type of device (§ 15 MPBetreibV).
• Implantable devices: Additional information, documentation and retention duties apply to certain implants (§ 16 MPBetreibV).
• Medical device safety officer: Healthcare facilities that regularly have more than 20 employees must appoint a competent and reliable person with a medical, scientific, nursing, pharmaceutical or technical education (§ 6 MPBetreibV).

Device inventory and device logbook

Device inventory (Bestandsverzeichnis, § 14 MPBetreibV): An inventory must be kept for all active non-implantable devices at each site. It contains, among other things, the device designation, kind and type, lot code or serial number, year of purchase, name or company and address of the manufacturer or the authorised representative or, where applicable, the importer, an existing internal identification number, and the location and organisational assignment.

Device logbook (Medizinproduktebuch, § 13 MPBetreibV): It must be kept for the devices listed in Annexes 1 and 2, subject to statutory exceptions for certain types of device. It records, among other things:

• the unique device identification,
• where applicable, evidence and details of the functional test and instruction,
• deadlines, date and result of mandatory safety and metrological controls and IT security reviews, the date of maintenance and the person or company that carried it out,
• malfunctions and repeated similar user errors,
• incident reports.

The device logbook must be kept for five years after the device is taken out of service.

Software and IT security

Special requirements apply under § 17 to medical device software of classes IIb and III and in-vitro diagnostic software of classes C and D. Before the software is operated, it must first be verified, among other things, that it has been properly installed, and a person appointed by the operator must have received the required instruction. If such software is operated and used in a healthcare facility, appropriate IT security reviews must also be carried out in accordance with the generally recognised rules of technology (allgemein anerkannte Regeln der Technik). They are required no later than every two years; earlier review may be necessary depending on the conditions of use and environment. A record with the date and results must be made of each IT security review, and the prescribed details must also be documented in the device logbook.

Keeping deadlines in view

The difficulty is rarely a single duty but the sheer volume: hundreds of devices, each with its own deadlines for inspections and maintenance, spread across several sites. Which duties apply to a device depends on its type, its use and its regulatory characteristics. Important factors include whether it is covered by Annex 1 or Annex 2, whether it is an active non-implantable device, and whether special requirements apply, for example to certain software. What matters is an up-to-date inventory and deadlines that become visible for each device before they expire.

This text is general guidance, not legal advice. German law applies, and the German-language text of the ordinance is authoritative: MPBetreibV on gesetze-im-internet.de.