Device file, inventory, briefings

In detail

Who it applies to

The Medical Device Operators Regulation (MPBV) covers setting up, operating, using and maintaining medical devices in health facilities and other facilities § 1(1) MPBV. The operator is whoever is responsible for running the facility § 2 no. 2 MPBV, in a single practice the owner, in a group practice the company. It was amended by Federal Law Gazette II No. 259/2026; the changes have applied since 1 September 2026 § 13(2) MPBV.

Briefing

• Everyone who handles a medical device must be briefed for that device type, by medical device advisers or suitable people, including from the practice itself. That isn't needed for people who, given their training, knowledge or experience, can be assumed to know the content already § 4(1) MPBV.
• The briefing covers handling, use according to the instructions, reprocessing, checks before use, and maintenance done by the user § 4(3) MPBV.
• For the devices in Annex 1 it is documented: device, manufacturer, type; name and date of birth or staff number of the person briefed; name of the person briefing and the date; the signature of the person briefed § 4(2), (4) MPBV. In a dental practice, Annex 1 covers, for example, defibrillators, devices that coagulate or remove tissue with energy, and devices monitoring vital signs Annex 1 MPBV.
• Repeat training must be provided where needed, for instance after repeated operating errors or software updates that change how a device works § 4(6) MPBV.

The device file

For medical devices that need regular safety checks or metrological checks, the operator names a person responsible for the device file. Any medium is allowed, paper included § 8(1) MPBV. It contains § 8(2) MPBV:

1. the name and item-level identification,
2. the purchase date,
3. the incoming inspection,
4. briefings, unless kept separately,
5. intervals, date, result and inspector of the safety checks,
6. the same for metrological checks,
7. repairs and the checks after them,
8. name and address of contractors for checks and maintenance,
9. safety-relevant incidents,
10. reports under § 40 of the Medical Devices Act 2021,
11. the date of final decommissioning.

It must be kept current, accessible during operating hours, and kept for five more years after final decommissioning § 8(3) MPBV.

The inventory

For all active medical devices ready for use, the operator keeps an inventory with: the UDI where there is one, otherwise name, kind, type, lot or serial number and year of manufacture; manufacturer; distributor; the notified body's number; location. It can be kept together with the device file § 9 MPBV.