Instruction and device logbook under the MPBetreibV
Supervisory authorities and auditors like to check two records in particular: who was instructed in which device and when, and what is recorded in the device logbook (Medizinproduktebuch)? This overview explains both topics under the German Medical Devices Operator Ordinance (MPBetreibV).
Instruction (Einweisung, § 4 MPBetreibV)
Devices may only be operated or used by persons who have the necessary training or knowledge and experience. In addition, instruction in the proper handling of the device is required. Exceptions apply where instructions for use are not required or the person has already received instruction for a device of the same design. For software, renewed instruction is also required after software updates if they change handling during operation and use by more than a minor degree.
For active non-implantable devices, the instruction must be documented in a suitable form. This is not a recommendation but an obligation.
Stricter rules for Annex 1 devices (§ 11 MPBetreibV)
Devices listed in Annex 1, such as defibrillators, certain ventilators or infant incubators, may in principle only be operated after the manufacturer, or an authorised person acting with the manufacturer's agreement, has carried out a functional test of the device at the place of operation and has instructed a person appointed by the operator accordingly. Evidence of both the functional test and the instruction must be retained. Afterwards, only persons instructed accordingly may operate these devices.
The device logbook (§ 13 MPBetreibV)
A device logbook 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 of the functional test and instruction, the person appointed by the operator, the time of the instruction and the names of the persons instructed,
- 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 so that users can access the information during working hours. After the device is taken out of service, it must be kept for five years.
What works well in practice
The law only requires that instruction be documented “in a suitable form”. For a traceable record of instruction, it has proved useful in practice to note in particular the device or device type, the serial number where appropriate, the date, the person instructed and the person or body that gave the instruction.
With staff changes, shift work and several sites, documentation quickly becomes demanding: new users must receive the instruction that is required, and the records must still be findable months later. Slips of paper and scattered spreadsheets are error-prone in the long run.
How Aurel helps
Aurel supports the documentation of instruction and assigns evidence, deadlines and completed measures to the respective device. This lets you manage the information for the device logbook in a structured way, without maintaining parallel spreadsheets.
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