Safety and metrological controls under the MPBetreibV
Two kinds of control make sure that certain medical devices work safely and accurately: the safety inspection (sicherheitstechnische Kontrolle, STK) and the metrological control (messtechnische Kontrolle, MTK). Both are set out in the German Medical Devices Operator Ordinance (MPBetreibV) and are subject to statutory inspection deadlines. This overview explains which devices they apply to and what they involve. In this guide, “operator” means the person or organisation legally responsible under the MPBetreibV, not the individual user of the device.
The difference in one sentence
The STK (§ 12 MPBetreibV) checks the technical safety of a device. The MTK (§ 15 MPBetreibV) checks whether a device with a measuring function stays within the permitted maximum measurement errors (error limits).
For an STK, the two-year period is calculated from the end of the month in which the device was commissioned or the previous STK was performed. For an MTK, the periods specified in Annex 2 begin at the end of the year in which the device was commissioned or the previous MTK was performed.
Safety inspections (§ 12 MPBetreibV)
Which devices: For devices listed in Annex 1, the operator must carry out safety inspections, or have them carried out, in accordance with the generally recognised rules of technology (allgemein anerkannte Regeln der Technik). Annex 1 includes, among others:
- non-implantable active devices that generate and apply electrical energy to directly influence nerves, muscles or heart activity, including defibrillators,
- active devices for mechanical ventilation, except sleep apnoea therapy devices,
- devices for diagnostic imaging based on nuclear magnetic resonance,
- devices for hyperbaric chamber therapy or hypothermia therapy,
- infant incubators,
- external active components of active implants.
Annex 1 contains further groups. The complete list in the ordinance is authoritative.
Deadline: The inspection must in principle be carried out no later than every two years, counted from the end of the month of commissioning or of the last inspection. If defects are to be expected sooner because of the actual conditions of use and environment, the inspection must take place earlier. These requirements apply accordingly to other devices and to items connected to Annex 1 devices. Special rules for defibrillators intended for use by laypersons are set out in § 12 paragraph 2.
Evidence: The person carrying out the inspection prepares a record with the date, the results including measured values, and the procedures used. After a successful inspection, the device is marked so that the date of the next inspection and the person, company or body that carried it out are clearly and traceably identifiable. The operator keeps the record until the next inspection.
Who may inspect: The operator may only commission persons, companies or bodies that meet the qualification requirements of § 5 MPBetreibV for the device concerned.
Metrological controls (§ 15 MPBetreibV)
Which devices: For devices listed in Annex 2, the operator must carry out metrological controls, or have them carried out, in accordance with the generally recognised rules of technology. In general, the control uses measurement standards that are traceable to national or international standards and meet the prescribed requirements for error limits and measurement uncertainty. Proper performance is presumed if the guideline of the Physikalisch-Technische Bundesanstalt (PTB, Germany's national metrology institute) on metrological controls of devices with a measuring function is followed.
Deadlines: They differ by type of device and begin at the end of the year in which the device was commissioned or the last MTK was carried out. Annex 2 lists, among others:
- pure-tone and speech audiometers: 1 year,
- infrared radiation thermometers: 1 year,
- medical electrical thermometers: 2 years,
- non-invasive blood pressure monitors: 2 years,
- eye tonometers: 2 years,
- pedal ergometers: 2 years,
- diagnostic dosimeters: 5 years.
For therapy dosimeters and further device groups, Annex 2 sets its own deadlines and exceptions. The complete list in Annex 2 is authoritative. If there are indications that a device does not stay within its error limits, or its metrological properties may have been affected by an intervention or in some other way, an MTK must be carried out without undue delay, regardless of the regular deadline.
Evidence and who may carry it out: Here too, a record is prepared with the date, the results including measured values, and the procedures used, and the device is marked so that the year of the next control and the authority or person that carried it out are clearly and traceably identifiable. The control may be carried out by the authorities responsible for legal metrology and by persons, companies or bodies that meet the requirements of § 5 MPBetreibV.
Documentation in the device logbook
A device logbook (Medizinproduktebuch) must be kept for devices in Annexes 1 and 2, subject to statutory exceptions. It records, among other things, the deadlines, date and result of mandatory safety and metrological controls and IT security reviews, as well as the date of maintenance and the person or company that carried it out.
What matters in practice
The individual control is rarely the problem, but its date is. In our experience, these points most often lead to gaps:
- STK and MTK deadlines are calculated under different rules (month versus year) and are therefore scheduled wrongly.
- A device has different deadlines for STK and MTK that are not considered together.
- Records from the service provider are scattered and cannot be matched to the device.
- After a move, repair or change of ward, it is unclear when the device was last checked.
How Aurel helps
Aurel assigns deadlines, completed measures and related evidence to the respective device and highlights upcoming deadlines in advance. This lets you manage inspection dates and records in a structured way, without maintaining parallel spreadsheets.
Book a call