Operator obligations under the Medical Devices Act (MPG) and the Medical Devices Operator Ordinance (MPBetreibV)

Medical devices are used for prevention, diagnosis, therapy or rehabilitation. Their main effect is physical rather than pharmacological, immunological or metabolic. Medicines and personal protective equipment are not medical devices.

The Medical Devices Act (MPG) and the Medical Devices Operator Ordinance (MPBetreibV) set out numerous requirements that must be observed in everyday working life. These range from creating inventories and medical device logs to testing and maintaining medical devices and reporting obligations.

Getting an overview of the numerous requirements poses a considerable challenge for most operators. To provide an overview, the obligations of operators are briefly outlined below.

Maintenance:

All active medical devices must be guaranteed to function properly, which is achieved through maintenance, servicing and hygienic reprocessing. This work may only be carried out by qualified companies. To ensure that this is done properly and correctly, every operator should create an inventory of their medical devices and keep it up to date. It should be noted that radiation protection tests for X-ray equipment must be carried out at least every five years.

Furthermore, requirements for active medical devices continue to apply in accordance with MPBetreibV Annexes 1 & 2:

The devices listed in Appendix 1 include, for example, laser devices, TENS devices, nerve function devices and anaesthesia devices. The devices listed in Appendix 2, on the other hand, include blood pressure monitors.

For this type of equipment, it is mandatory to keep medical device logs and carry out safety inspections (STK).

The medical device logs (MP log) must contain MP identification data, evidence of functional testing and initial training, names of trained persons, results of inspections, maintenance/testing contracts, malfunctions and incident reports. To ensure that the records are kept up to date, they must be accessible to the user during working hours. Non-electrical blood pressure monitors are exempt from the MP record.

Safety checks (STK) must be carried out primarily for products listed in Annex 1, but also for other products if required by the manufacturer. The maximum interval for this is two years, unless the manufacturer specifies otherwise. Authorised inspectors must be demonstrably sufficiently qualified, independent and have the appropriate measuring and testing equipment at their disposal. It is important to draw up a test report; without a test report, the STK is considered non-existent.

For active and non-active medical devices in accordance with MPBetreibV Annex 2, however, regular and recurring metrological checks (MTK) must be carried out. This serves to determine the extent to which the maximum permissible error tolerances are being complied with. The inspection intervals can be found in Annex 2 of the MPBetreibV. For example, they are one year for audiometers, two years for manual and electric blood pressure monitors and ergometers, and five years for tonometers.

Furthermore, all active medical devices that are powered by electricity must be tested in accordance with DGUV Regulation 3. The operator determines the test intervals on the basis of their risk assessment. This also includes laboratory equipment such as centrifuges, microscopes and sterilisers.

Medical device representatives (MPB):

Medical device representatives (MPB) are also required for products in accordance with MPBetreibV Annex 1. The task of MPBs is to accept devices from the manufacturing or supplying company and to receive instruction on their use. MPBs are not responsible for testing, maintenance, reporting obligations or documentation of the devices. These tasks must be delegated separately to competent persons.

Requirements for persons who operate medical devices:

Persons who operate, own or use a medical device (MD), such as medical assistants, assistant doctors and patients, must be instructed in the use of devices listed in Annex 1 of the MPBetreibV by the manufacturing or supplying companies or the medical device representative. It is important that you have relevant knowledge and experience. A further requirement is to check the functionality and proper condition of the active MP before each use. If an error occurs during this process or during handling, there is an immediate obligation to report it. The forms for reporting can be downloaded at www.dimdi.de. The competent authority is the Federal Institute for Drugs and Medical Devices (BfArM).

Instruction manual:

Every medical device must come with an instruction manual for use. The manual supplied must be available for employees to consult at all times. The only exception to this rule is for simple devices such as clinical thermometers.

Training:

To ensure that the numerous requirements are always kept in mind, users of medical devices must receive regular training. The training must be documented and retained.

HSE-Ingenieure GmbH is happy to assist you in implementing the operational requirements of the Medical Devices Act (MPG) and the Medical Devices Operator Ordinance (MPBetreibV).

Please feel free to contact us by telephone or email to arrange a preliminary consultation.