According to BIV-OT, the reform significantly reduces the bureaucratic burden for service providers and involves insured persons in the responsibility. (Photo: © Aktion Modernes Handwerk)
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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.
A new version of the Medical Device Operator Ordinance (MPBetreibV) came into force on 19 February 2025. It specified the Concept of "Operator" and arranges his obligations new. Also for maintenance of medical devices there is now a clear and practical regulation.
The MPBetreibV provides Requirements to operating a Medical device. The medical devices may only be used by persons operated or used by persons who have not received the necessary training or knowledge and have experience.
The new § 2 MPBetreibV Are defined the term "Operator" as follows: "The 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. By way of derogation from sentence 1, the operator of a product owned by a member of the healthcare profession or health trade and brought by that member into a healthcare facility for use is the respective member of the healthcare profession or health trade. Anyone who makes products available for use outside of healthcare facilities is also considered an operator.
The Operators must, among other things, carry out the following: maintenance and processing, user training, safety checks, keeping a medical device log and inventory, metrological checks and IT security checks.
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The Federal Guild Association for Orthopaedic Technology (BIV-OT) describes the reform as a "decisive progress". you shadows the bureaucratic effort for service providers and includes the insured This means greater security, flexibility, and efficiency for everyone involved.
The changes are based on a common Initiative Federal Guild Association for Orthopaedic Technology (BIV-OT), the GKV-Spitzenverband, the AOK Bundesverband, the AOK Bayern and the AOK PLUS. She was able to Federal Ministry of Health (BMG) the comprehensive revision of the MPBetreibV. To further facilitate implementation, the associations are developing job aids for sample forms to ensure consistent and understandable communication with the insured.
The complete Text of the regulation can be found in Federal Law Gazette by 19.02.2025 I No. 38 and No. 39.
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