Device inventory under § 14 MPBetreibV
The device inventory (Bestandsverzeichnis) is the foundation of all medical device documentation: if you do not know which devices are in use where, you can neither monitor deadlines nor prove that inspections took place. § 14 of the German Medical Devices Operator Ordinance (MPBetreibV) sets out what belongs in it.
Which devices does it cover?
The operator must keep an inventory of all active non-implantable devices at each site. This includes many medical devices powered electrically or by other forms of energy, for example infusion pumps, patient monitors, defibrillators or ultrasound systems. Non-active devices and implantable devices are not covered by the inventory duty under § 14. Special duties apply instead to certain implants under § 16 MPBetreibV.
What information is required?
For each device, the following must be entered, among other things:
- designation, kind and type of the device,
- 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,
- the internal identification number, where one exists,
- location and organisational assignment.
In what form?
Any data medium may be used for the inventory, as long as the required information can be made readable within a reasonable period.
What matters in practice
The required fields are quickly captured. The difficulty lies in daily operation. In our experience, these points most often lead to gaps:
- Newly purchased devices are entered late or not at all.
- Location and assignment are wrong after a move or a change of ward.
- Serial numbers are missing or copied incorrectly.
- Decommissioned devices stay on the list.
- Several sites keep their own spreadsheets with different layouts.
The inventory is also the starting point for further evidence. For devices in Annexes 1 and 2, the device logbook (Medizinproduktebuch) is added, subject to statutory exceptions, recording instruction, inspections and maintenance.
How Aurel helps
Aurel builds your device inventory from your existing list and keeps location and assignment for each device. Aurel assigns deadlines, completed measures and related evidence to the respective device. This lets you manage key evidence in a structured way, without maintaining parallel spreadsheets.
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