German Medical Devices Operator Ordinance (Medizinprodukte-Betreiberverordnung)

Under § 2(2), the operator is any natural or legal person responsible for running the health care facility in which employees operate or use the device. A health care facility is any facility in which devices are operated or used by medical staff, nursing professionals or other authorized persons, including rehabilitation and nursing facilities. The user is whoever applies a device to a patient (§ 2(3)).

The operator must perform the duties assigned by the ordinance to ensure safe and proper operation and use (§ 3(1)). The operator may assign tasks to service providers but remains responsible. Maintenance, safety checks, metrological checks and IT security checks may only go to persons, businesses or institutions that meet the requirements of § 5 (§ 7(3), § 12(4), § 15(6), § 17(4)).

An exception applies when a supplier (Versorgender) provides devices that remain the supplier's property. Then the supplier has the operator duties and can transfer individual tasks to third parties by contract but must still ensure they are performed properly (§ 3(2)). In daily terms: contracts with service companies should settle the qualification under § 5, the records and the deadline notices. They cannot replace the operator's responsibility.

Safety checks (STK) are prescribed for the products in Annex 1. These are non-implantable active products for generating and applying electrical energy to nerves, muscles or the heart, including defibrillators, for measuring in blood vessels, for coagulation or tissue destruction, for introducing substances into the bloodstream with potential pressure buildup, for mechanical ventilation, for diagnosis by nuclear magnetic resonance, for therapy with pressure chambers or hypothermia, as well as infant incubators and external active components of active implants. For other products and objects connected to Annex 1 products, the provisions apply accordingly (§ 12(1) sentence 5).

The checks must be done at least every two years, by the end of the month in which the product was put into operation or last checked. If, because of the conditions of use and the environment, defects are to be expected earlier, the check must take place before that. Measuring functions are included. For automated external defibrillators for lay users, the STK can be dropped if the device performs self-tests and the operator inspects it visually at regular intervals. For newly commissioned devices, remote monitoring of the self-tests applies in addition from 1 January 2027 (§ 12(2)).

The person doing the check writes a report and marks the product with the year and month of the next check (§ 12(3)). Missing a check is an administrative offense (§ 19 No. 7). The fine can be up to 30,000 euros (§ 94(5) MPDG).

Metrological checks (MTK) are prescribed for the products in Annex 2, meaning products with a measuring function. They determine whether the product stays within the permitted maximum measurement deviations (§ 15(2)). Proper performance is presumed if the guideline of the national metrology institute, the Physikalisch-Technische Bundesanstalt, is followed (§ 15(1)). It is published in its current version on the institute's website.

The intervals are in Annex 2, in years. Pure-tone and speech audiometers and infrared radiation thermometers: one year. Medical electrical thermometers, thermometers with interchangeable probes, devices for noninvasive blood pressure measurement, eye tonometers and pedal ergometers: two years. Diagnostic dosimeters: five years. For therapy dosimeters, two years are specified, and six years with a control device and semiannual control measurements.

The intervals start at the end of the year in which the product was put into operation or last checked (§ 15(5)). Checks must be done without delay if there are signs that the error limits are exceeded or the metrological properties may have been affected by an intervention. Only standards that are traceable to a national or international standard may be used. After the check, the product must be marked with the year of the next check and the inspecting body (§ 15(7)). Annex 2 was reissued in November 2025, retroactively from 20 February 2025.

Where the ordinance sets special requirements for an activity, it may only be carried out by someone who has current knowledge based on suitable training and relevant professional activity, is not subject to instructions regarding technical assessment and has the means required, including suitable measuring and testing equipment (§ 5). These three conditions apply equally to maintenance, reprocessing, safety and metrological checks and IT security checks. As operator, you verify this at contract signing and whenever the service provider changes staff.

Maintenance includes servicing, inspections and repairs. The manufacturer's instructions must be considered, and appropriate measures must also be taken after safety-relevant incidents (§ 7(2)). After maintenance, the structural and functional features essential for the safety and function of the products must be checked, to the extent the measures could have affected them (§ 7(4)). That applies to every maintenance task and is not limited to the STK.

Anyone who does not carry out maintenance, or does not have it carried out, properly commits an administrative offense (§ 19 No. 2a). That also applies to commissioning an unsuitable provider (§ 19 No. 3). Ask the provider for proof of training and test equipment, and record which devices were checked with which measuring instrument.

An inventory register must be kept for all active non-implantable products at each site (§ 14(1)). For each product it contains the designation, type and model, lot code or serial number, year of purchase, the name and address of the manufacturer or authorized representative or importer, the operator's identification number if there is one, and the location and organizational assignment (§ 14(2)). Any data carrier is allowed as long as the data can be made readable within a reasonable time. The register may also be kept within a register that exists under other rules.

For products in Annexes 1 and 2, the medical device logbook is added (§ 13). It contains the identification, the proof of function test and briefing, the names of the person commissioned and of those briefed, the intervals, dates and results of the prescribed safety and metrological checks and IT security checks, the dates of maintenance with the person or company performing it, malfunctions and repeated operating errors, and reports to authorities and manufacturers. The logbook must be accessible to the user during working hours and be kept for five years after the product is taken out of service.

The operator keeps the check reports until the next check. A missing or incomplete logbook is an administrative offense (§ 19 No. 9). vi maintains the inventory register and the deadlines from service reports and invoices and keeps proof ready per device.

Maintenance of software includes installing safety-relevant software updates (§ 7(2)). Persons who do not meet the special requirements of § 5 may also perform this installation (§ 7(3) sentence 2). If an update changes how the user handles the software by more than a minor amount, a new briefing is needed after each installation (§ 4(3)). For networked products, the manufacturer's requirements for the digital infrastructure must be observed when connecting to a network (§ 4(6)).

For software that is a medical device of classes IIb and III and for in vitro diagnostic software of classes C and D, § 17 also applies, since 1 August 2025. Before commissioning, the manufacturer or a person authorized by it must check the installation and brief a person commissioned by the operator. The installation check can also take place by remote access. If the software is run in a health care facility, the operator must carry out, or have carried out, appropriate IT security checks at least every two years, by the end of the month of installation or of the last check, and earlier if defects are to be expected. A report with the date and results must be written.

These checks, like all special activities, may only be performed by persons and companies with the right qualifications. If you use remote maintenance, record in the service contract who has access and who approves updates.