Technical Service: MTK, STK & Repairs

Technical Service

Overview

For almost 35 years, we have been your reliable and competent on-site service provider for medical technology and digital solutions. Many years of experience and continuous training enable us to support you comprehensively and professionally – from the medical technology concept of a practice or hospital and the selection of equipment to the mandatory regular monitoring of devices, its documentation and any repairs that may be required. Depending on your needs, we provide individual services or take complete care of your medical technology as your responsible outsourcing partner.

Many of our products are medical devices with a measuring function. With responsibility shared between manufacturer / specialist dealer and user, many of these devices are subject to mandatory metrological checks (MTK) in accordance with the German Medical Devices Operator Ordinance (MPBetreibV, Annex 2) or the German Measurement and Verification Ordinance (MessEV). We are fully qualified to carry out these checks.

We also carry out accident prevention (UVV) inspections of electrical equipment in accordance with regulations 3 and 4 of the German Social Accident Insurance (DGUV V3, DGUV V4), which cover practically ALL electrical devices in commercial use, including electrical medical devices. During this safety check (STK) we examine functionality in order to detect device defects and hazards in good time, before they pose a risk to patients, users or third parties.

We are a registered maintenance service, and our teams have the legally required qualifications to carry out MTK and STK for most product groups. Our staff are equipped with high-quality test and measuring instruments and receive regular training. In addition, we share skills and resources with other strong partners in our network, so that we can keep our promises to our customers.

We will also be happy to take care of the medical technology service and maintenance of your devices.

Use our service requirements form (German, PDF) to send us further information, on the basis of which we will prepare an individual service offer for you. Alternatively, we will be happy to advise you at an on-site meeting. We look forward to hearing from you.

MTK – metrological checks

Under the German Medical Devices Operator Ordinance (MPBetreibV), many medical devices are subject to regular metrological checks. The requirements for MTK are described in detail in Section 15 and the associated Annex 2 of the MPBetreibV. We have compiled the relevant extracts of the ordinance for you below.

Unofficial translation for information purposes only. Only the German text of the ordinance is legally binding.

Ordinance on the installation, operation and use of medical devices (Medical Devices Operator Ordinance – MPBetreibV)

Section 15 Metrological checks

(1) For the medical devices listed in Annex 2, the operator shall carry out, or have carried out, metrological checks in accordance with paragraph 4 and the generally recognised rules of technology. Proper performance of the metrological checks pursuant to sentence 1 is presumed if the guideline on metrological checks of medical devices with a measuring function issued by the Physikalisch-Technische Bundesanstalt (PTB) is observed. The current version of the guideline is published on the PTB website and archived by the PTB.

(2) The metrological checks determine whether the medical device complies with the maximum permissible measurement deviations (error limits) specified in the guideline referred to in paragraph 1 sentence 2.

(3) Unless otherwise specified in Annex 2, only measurement standards that are traceable to a national or international standard and have sufficiently small error limits and measurement uncertainties may be used for the metrological checks. The error limits and measurement uncertainties are deemed sufficiently small if they meet the requirements of the guideline referred to in paragraph 1 sentence 2 or if they do not exceed one third of the error limits and measurement uncertainties of the medical device being tested.

(4) The metrological checks shall be carried out within the intervals specified in Annex 2. The same intervals apply to repeat checks. The intervals begin at the end of the year in which the medical device was put into service or the last metrological check was carried out. A metrological check shall be carried out without delay if

there are indications that the medical device does not comply with the error limits pursuant to paragraph 2, or
the metrological properties of the medical device may have been affected by an intervention or in any other way.

(5) The operator may only commission the following to carry out metrological checks:

authorities responsible for metrology, or
persons, companies or institutions which themselves, or whose employees carrying out the metrological checks, meet the requirements of Section 5 with regard to the metrological checks of the respective medical device.

(6) Persons intending to carry out metrological checks in future shall notify the competent authority before carrying out the first metrological check and, at the request of the competent authority, prove that they meet the requirements of Section 5.

(7) Whoever carries out metrological checks shall

prepare a report on the metrological check containing the date of performance and the results of the metrological check, stating the measured values, the measurement methods and other assessment results, and
mark the medical device with a label after a successful metrological check; the label must clearly and traceably indicate the year of the next metrological check and the authority or person who carried out the metrological check.

The operator shall keep the report pursuant to sentence 1 number 1 at least until the next metrological check.

Annex 2 (to Section 12 (1) and Section 15 (1))

(Source: Federal Law Gazette BGBl. I 2002, 3404; for individual amendments see footnote)

1	Medical devices subject to metrological checks pursuant to Section 15 (1) sentence 1
			Check intervals in years
1.1	Medical devices for determining hearing ability (tone and speech audiometers)		1
1.2	Medical devices for determining body temperature (with the exception of mercury-in-glass maximum thermometers)
1.2.1	-	medical electrical thermometers	2
1.2.2	-	with interchangeable temperature sensors	2
1.2.3	-	infrared radiation thermometers	1
1.3	Instruments for non-invasive blood pressure measurement		2
1.4	Medical devices for determining intraocular pressure (tonometers)		2
1.4.1	-	(repealed)
1.4.2	-	(repealed)
1.5	Therapy dosimeters for external treatment of patients
1.5.1	with photon radiation in the energy range up to 1.33 MeV
	-	general	2
	-	with a suitable control device, if the operator carries out control measurements at least every six months in each measuring range of the dosimeter, records the results and the existing requirements are met	6
1.5.2	with photon radiation in the energy range from 1.33 MeV and with electron radiation from accelerators, with metrological checks in the form of comparative measurements		2
1.5.3	with photon radiation from Co-60 irradiation units, optionally in accordance with 1.5.1 or 1.5.2
1.6	Diagnostic dosimeters for carrying out measurement and testing tasks, unless they are subject to the Measurement and Verification Act pursuant to Section 90 of the Radiation Protection Ordinance		5
1.7	Crank ergometers for the defined physical and reproducible exercise loading of patients		2
2	Exemptions from metrological checks
	Exemptions from metrological checks By way of derogation from number 1.5.1, therapy dosimeters are not subject to metrological checks if they are calibrated in the measuring ranges used after every influence that may affect the accuracy of the measurement, and at least every two years, and the results are recorded. Calibration must be carried out by competent persons designated by the operator, using a therapy dosimeter whose accuracy has been ensured in accordance with Section 15 (2) and which is permanently available at the facility performing the therapy.
3	Metrological checks in the form of comparative measurements
3.1	Air-puff tonometers (1.4) are not traced back to a national standard, but to a clinically tested reference device of the same design. Only procedures and transfer standards tested by a national metrology institute may be used for this comparison.
3.2	Comparative measurements pursuant to 1.5.2 are carried out by a measuring body commissioned by the competent authority.

Source: German Federal Ministry of Justice and Federal Office of Justice.

STK & DGUV V3, DGUV V4 – safety checks

To ensure workplace safety, employers must have electrical devices, systems and machines inspected regularly in accordance with the accident prevention regulations for electrical equipment (UVV). This safety check (STK for medical devices) is intended to detect device defects and hazards in good time, before they pose a risk to patients, users or third parties.

The accident prevention regulations (UVV) set out the rules and procedures for the inspection of electrical equipment, which are specified in more detail in DGUV regulations 3 and 4 (DGUV V3, DGUV V4).

For medical devices, Section 12 of the German Medical Devices Operator Ordinance (MPBetreibV) is also binding for the periodic safety inspection of the products listed in Annex 1 of the MPBetreibV. We have compiled the relevant extracts of the ordinance for you below.

Unofficial translation for information purposes only. Only the German text of the ordinance is legally binding.

Ordinance on the installation, operation and use of medical devices (Medical Devices Operator Ordinance – MPBetreibV)

Section 12 Safety checks

(1) For the medical devices listed in Annex 1, the operator shall carry out, or have carried out, safety checks in accordance with the generally recognised rules of technology and with sentence 2 or sentence 3. The operator shall set intervals for the safety checks such that defects which, based on experience, must be expected can be detected in good time. However, the safety checks shall be carried out at least every two years, at the end of the month in which the medical device was put into service or the last safety check was carried out. The safety checks include the measuring functions. Sentences 1 to 3 apply accordingly to other medical devices and accessories, including software or other items that the operator uses in connection with medical devices pursuant to sentence 1.

(2) By way of derogation from paragraph 1, a safety check may be omitted for automated external defibrillators in public spaces intended for use by lay persons if the automated external defibrillator is self-testing and the operator carries out regular visual inspections.

(3) A report shall be prepared on the safety check, containing the date of performance and the results of the safety check, stating the measured values, the measurement methods and other assessment results. The operator shall keep the report pursuant to sentence 1 at least until the next safety check.

(4) The operator may only commission persons, companies or institutions to carry out the safety checks which themselves, or whose employees carrying out the safety checks, meet the requirements of Section 5 with regard to the safety checks of the respective medical device.

Annex 1 (to Section 11 (1) and (2), Section 12 (1) and Section 13 (1))

(Source: Federal Law Gazette BGBl. 2025 I No. 38, p. 12)

1	Non-implantable active devices for
1.1	generating and applying electrical energy to directly influence the function of nerves and/or muscles or cardiac activity, including defibrillators,
1.2	intracardiac measurement of electrical variables or measurement of other variables using electrically operated measuring probes in blood vessels or on exposed blood vessels,
1.3	generating and applying any energy for direct coagulation, tissue destruction or fragmentation of deposits in organs,
1.4	direct introduction of substances and fluids into the bloodstream under potential pressure build-up, whereby the substances and fluids may also be processed or specially treated endogenous ones whose introduction is directly coupled with a withdrawal function,
1.5	mechanical ventilation with or without anaesthesia, with the exception of sleep apnoea therapy devices,
1.6	diagnosis using imaging procedures based on the principle of nuclear magnetic resonance,
1.7	therapy with pressure chambers,
1.8	therapy by means of hypothermia and
2	infant incubators, and
3	external active components of active implants.

Source: German Federal Ministry of Justice and Federal Office of Justice.

Repairs

Each of our workshops has its own stock of important spare parts and a pool of loan devices, so that we can offer quick solutions if devices fail in critical infrastructure.
We also use our workshops to train apprentices and new employees intensively in the correct working techniques.
Customer service working across all our locations ensures that you always have a competent contact person.