STK, MTK, inventory list: without gaps.

The safety inspection (STK) is required for the products in Annex 1 of the Medical Devices Operator Ordinance (MPBetreibV). These include non-implantable active products such as defibrillators, devices that introduce substances into the bloodstream with potential pressure build-up (for example infusion and syringe pumps), ventilators, magnetic resonance scanners, pressure chambers, hypothermia devices and infant incubators. For other products, and for objects connected to Annex 1 products, the same sentences apply accordingly.

The interval: at the latest every two years, counted to the end of the month in which the product was put into operation or last inspected. If, because of the conditions of use and the environment, defects are to be expected earlier, you must inspect earlier. The safety inspection includes the measuring functions.

Only someone who meets § 5 may carry it out: up-to-date knowledge from training and professional work, no instructions on the technical assessment, and the necessary means, such as suitable measuring and test equipment. The inspector writes a report with the date, results, measured values and measuring methods, and after a successful inspection marks the device with the year and month of the next STK. You keep the report until the next inspection. vi reads the reports and enters the next due date for each device into the calendar.

The metrological inspection (MTK) applies to products with a measuring function listed in Annex 2 of the MPBetreibV. Examples are devices for non-invasive blood pressure measurement, medical thermometers, audiometers, eye pressure tonometers, certain dosimeters and bicycle ergometers. The re-inspection intervals are stated in Annex 2 in years. As examples: two years for non-invasive blood pressure monitors and medical electronic thermometers, one year for infrared radiation thermometers and for audiometers.

The intervals begin at the end of the year in which the product was put into operation or last inspected. Outside the interval, the MTK is required without delay if there are indications that the device does not meet the error limits, or if its metrological properties may have been affected by an intervention or in some other way, for example after a repair. A product in Annex 2 may only be operated if it meets the error limits stated in the guideline of the national metrology institute, the Physikalisch-Technische Bundesanstalt.

You may commission the authorities responsible for metrology, or persons and companies that meet the requirements of § 5. As with the STK, there is a report and a marking with the year of the next inspection. If STK and MTK coincide, the appointments can be combined. vi keeps both intervals for each device in one calendar.

You keep the inventory list for all active non-implantable products at the respective site. For each product, you enter: designation, kind and type, lot code or serial number, year of purchase, name and address of the manufacturer or its authorized representative, or failing that the importer, the internal identification number where there is one, and the location and organizational assignment. Any data carrier is permitted as long as the information can be made legible within a reasonable time.

You keep the medical device log for the products in Annexes 1 and 2, that is, all devices with an STK or MTK. Excluded are electronic clinical thermometers in compact form and blood pressure monitors with a mercury or aneroid gauge. The log holds: identification, proof of the functional test and instruction, the names of the appointed and instructed persons, intervals, date and result of safety and metrological inspections and IT security reviews, date and performer of maintenance, malfunctions and repeated operating errors of the same kind, and details of incident reports. After the device is taken out of service, you keep the log for five years.

The weak point is usually the inventory list: devices are moved, replaced or retired, and the list shows the old state. vi builds the inventory from reports, delivery notes and invoices and compares it with your list.

Safety first. Before every use, the user must make sure that the product is functional and in proper condition. If that is in doubt, the device is taken out of service and marked until the matter is clarified. After any maintenance, the design and functional characteristics that are essential for safety and function must be checked, to the extent that the work may have affected them. The service report should show that check.

Second, the report. Anyone who operates or uses products professionally or commercially must report presumed serious incidents to the competent federal authority without delay. An incident already counts if it cannot be ruled out that it is due to a malfunction, a deterioration in performance or a use error, and it led or could have led to death, a serious deterioration in health or a serious threat to public health. Healthcare institutions with regularly more than 20 employees must appoint a medical device safety officer. That person is the contact for authorities and manufacturers and coordinates the internal reporting channels.

Third, the documentation. The medical device log records the date, kind and consequences of malfunctions and the details of reports. vi flags failed inspections and attaches the proof of the repair to the device.

The operator must maintain products and the objects connected to them, or have them maintained. That includes maintenance and inspections that are needed for safe operation and repairs to restore function. The manufacturer's information must be taken into account. Appropriate measures are also needed after safety-relevant incidents. For software, installing safety-relevant updates is part of maintenance.

You may only commission persons, companies or institutions that meet the requirements of § 5 for the product concerned. The installation of safety-relevant software updates is an exception. From that follow the points for the service contract: proof of the qualification of the service staff, a scope of work in line with manufacturer specifications, a functional check after every repair, a service report with date, work, parts replaced, result and software version, response times and a loaner device, and the question of who approves updates and when they are installed.

Also check whether one provider can take on maintenance and inspections together. Then the second trip and the second invoice are no longer needed. Where several providers are responsible for device groups, services often overlap. vi shows such overlaps so you can bundle contracts.

Products that are intended to be used in a low-germ or sterile condition must be reprocessed using suitable validated procedures, in such a way that the success is verifiably ensured and nobody is endangered. Single-use devices are excluded. The manufacturer's information must be taken into account. Proper reprocessing is presumed if the joint recommendation of the Commission for Hospital Hygiene and Infection Prevention at the Robert Koch Institute and the Federal Institute for Drugs and Medical Devices on the hygiene requirements for reprocessing is followed.

For products with particularly high requirements, classified in the recommendation as "critical C", certification of the quality management system by a recognized notified body is a prerequisite. You may only commission bodies that meet the requirements of § 5. The validation and performance assessment of the reprocessing process must be carried out on behalf of the operator by qualified specialists, and the competent authority may check this.

For practice, this means: treat validation reports like inspection reports. They belong in the device documentation with date, device, procedure, result and remarks, and you set the next due date according to your quality management requirements. This applies to sterilizers as well as to washer-disinfectors. vi reads validation reports and files due dates and findings for each device.

A revised MPBetreibV has applied since February 2025 (Federal Law Gazette 2025 I No. 38). The current version of Annex 2 with the re-inspection intervals is published in Federal Law Gazette 2025 I No. 263. Interval lists from before that time should therefore be checked against the new version.

Among the changes is networking. When products are connected to a network, the manufacturer's requirements for the digital infrastructure with respect to information security must be observed. Software that is a medical device of classes IIb and III may only be operated if the manufacturer or a person authorized by it has first checked the installation and instructed a person appointed by the operator. In addition come appropriate IT security reviews, at the latest every two years, with a report. They also belong in the medical device log.

For automated external defibrillators intended for laypersons, the STK can be dropped if the device is self-testing and the operator carries out regular visual checks. For newly commissioned devices, from January 1, 2027 they must also document self-tests and transmit the results automatically to the operator on a regular basis. Keep track of which devices in your inventory are affected. vi keeps software versions and inspection records together for each device.