Tools: Less bureaucracy for the healthcare trades

An amended regulation brings more clarity and fewer bureaucratic hurdles to the provision of medical aids. The Federal Guild Association for Orthopaedic Technology advocated for the reform.

This article is part of the special feature on bureaucratic madness in the skilled trades.

A new version of the Medical Device Operator Ordinance (MPBetreibV) came into force on February 19, 2025. It clarifies the term "operator" and redefines their responsibilities . There is also now a clear and practical regulation for the maintenance of medical devices.

What does the Medical Device Operator Ordinance regulate?

The Medical Device Operator Ordinance (MPBetreibV) sets requirements for the operation of a medical device . Medical devices may only be operated or used by persons who possess the necessary training, knowledge , and experience.

The new Section 2 of the Medical Device Operator Ordinance (MPBetreibV) defines the term "operator" as follows: "An operator of a product is any natural or legal person responsible for the operation of the healthcare facility in which the product is operated or used by its employees. Notwithstanding sentence 1, the operator of a product owned by a healthcare professional or tradesperson and brought by that professional into a healthcare facility for use is that healthcare professional or tradesperson. Anyone who makes products available for use outside of healthcare facilities is also considered an operator."

The operator must, among other things, perform the following: maintenance and reprocessing, user training, safety checks, maintaining a medical device log and inventory, metrological checks and IT security audits.

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Associations: "Decisive progress"

The German Federal Association of Orthopedic Technology (BIV-OT) describes the reform as a "decisive step forward." It significantly reduces the bureaucratic burden for service providers and involves insured individuals in the decision-making process. This means greater security, flexibility, and efficiency for everyone involved.

The changes stem from a joint initiative of the German Federal Association of Orthopedic Technology (BIV-OT) , the National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), the Federal Association of AOK Health Insurance Funds (AOK Bundesverband), AOK Bayern, and AOK PLUS. This initiative successfully lobbied the Federal Ministry of Health (BMG) for a comprehensive revision of the Medical Device Operator Ordinance (MPBetreibV). To further facilitate implementation, the associations will next develop practical guides for sample forms to ensure consistent and easily understandable communication with insured individuals.

The full text of the regulation can be found in the Federal Law Gazette of 19 February 2025, Part I, Nos. 38 and 39.

The advisors at the Chambers of Crafts will be happy to help you with any legal questions!

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