The Medizinprodukte-Betreiberverordnung, usually shortened to MPBetreibV, is the German ordinance that governs the operation of medical devices. It does not regulate who may sell a device or how that device was approved, but what happens once the device is switched on in a real setting, which is the part a pharmacy tends not to expect. Buying an analyser is a purchase, whereas operating one is a role with duties attached.
The Betreiber is the natural or legal person who runs the device in their own organisation, which in a pharmacy means the pharmacy itself, represented by the owner. The obligation cannot be passed to the supplier who delivered the device or to the manufacturer who built it. If a Point-of-Care-Test device stands in the consultation room, the pharmacy is its Betreiber and answers for how it is run.
Three duties apply to daily practice:
- Anyone who uses the device has to be instructed on that specific device by a competent person before working with it unsupervised, and the instruction is documented with the name and the date.
- The ordinance expects a Bestandsverzeichnis of the devices the pharmacy operates and, for the devices it names, a Medizinproduktebuch, so a device can be traced from delivery through instruction, maintenance and any incident.
- Measuring devices are subject to the messtechnische Kontrolle, alongside the manufacturer maintenance intervals and the functional checks the Gebrauchsanweisung sets out.
These duties apply beside the checks a pharmacy runs on the measured values themselves rather than instead of them. The interne Qualitätskontrolle tells the pharmacy whether the device is measuring correctly today, while MPBetreibV decides whether the device may lawfully be operated at all, and by whom. Both belong in the written Qualitätssicherung rather than in one person's memory.
The ordinance also assumes the device is being used inside the intended purpose set out under the IVDR und CE-Kennzeichnung. A device operated outside that purpose is a problem no device log repairs. The workable order is to confirm first what the device is approved for, then to accept the Betreiber duties that come with running it, and only then to put it into service.
This glossary entry is general information about German pharmacy law and practice. It is not legal advice. For binding guidance on your own pharmacy, contact your Landesapothekerkammer.
