Guide & FAQ

The Safety Technical Control (STK) is a legally required inspection according to §12 MPBetreibV. It is mandatory for all operators of active, non-implantable medical devices listed in Annex 1 of the MPBetreibV. These include defibrillators, infusion pumps, ventilators, HF surgical devices, and lasers, among others.

The maximum legal interval is 24 months. However, the device manufacturer may specify shorter intervals in the instructions for use - these are then binding. We recommend always checking the manufacturer's specifications.

DIN EN 62353 covers only the electrical safety aspect of the STK. A complete STK additionally includes testing of all monitoring and alarm devices, device-specific functional tests (e.g., energy output measurement for defibrillators), mechanical safety inspection, and manufacturer-specific test checklists.

Missing the STK deadline is a violation of the MPBetreibV and can result in fines. In the event of damage, the operator faces significant liability risks. Additionally, the responsible authority may prohibit the operation of the devices.

The Metrological Control (MTK) according to §15 MPBetreibV verifies the measurement accuracy of medical devices with measurement functions (Annex 2). Affected devices include blood pressure monitors, clinical thermometers, audiometers, and ergometers, among others.

The MTK requires DAkkS-calibrated reference test equipment traceable to national standards (§15 para. 4 MPBetreibV). These must be recalibrated annually.

Yes! Devices not listed in Annex 1 of the MPBetreibV (e.g., ultrasound devices, laboratory equipment, hospital beds) must also be regularly tested according to DGUV Vorschrift 3 / DIN EN 62353.

The standard recommends test intervals of 6 to 36 months, typically 12–24 months. Manufacturer specifications take precedence. After every repair, a post-repair test is mandatory.

According to §5 MPBetreibV, three requirements must be met: 1) Current knowledge based on appropriate training and relevant professional experience, 2) Freedom from instructions in technical assessments, 3) Suitable resources (measuring instruments, test equipment). Alexander Driller meets all three requirements and is TÜV Süd certified.

IEC 62304 defines requirements for the software lifecycle of medical software. It is relevant for any manufacturer developing software as a medical device (SaMD) or as part of a medical device. Without IEC 62304 conformity, there is no CE marking.

A Digital Health Application (DiGA) is medical software that has been approved by the BfArM and included in the DiGA directory. DiGA can be prescribed by physicians and reimbursed by health insurance companies.