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Section 139 of Book V of the Social Code - List of medical aids; quality assurance in medical aids

(1) The National Association of Statutory Health Insurance Funds shall draw up a systematically-structured list of medical aids. The list shall stipulate the medical aids which are covered by the obligation to pay. The list of medical aids shall be announced in the Federal Gazette (Bundesanzeiger).

(2) Where this is necessary in order to guarantee adequate, expedient and economical care, the list of medical aids may stipulate indication- or deployment-related special quality requirements for medical aids. Particular quality requirements in accordance with sentence 1 may also be established in order to facilitate a sufficiently long useful life or the re-use of medical aids by other members in suitable cases. The list of medical aids may also regulate the requirements as to the benefits to be provided in addition to providing the medical aid.

(3) A medical aid shall be included in the list of medical aids at the request of the manufacturer. The National Association of Statutory Health Insurance Funds shall decide on inclusion; it may have the Medical Service examine whether the requirements in accordance with subsection (4) are met.

(4) The medical aid shall be included if the manufacturer has proven functionality and safety, compliance with the quality requirements in accordance with subsection (2) and, where necessary, the medical advantage, and it is provided with the information in German that is necessary for proper, safe handling.

(5) Proof of the functionality and safety of medical devices within the meaning of section 3 No. 1 of the Act on Medical Devices (Medizinproduktegesetz) shall as a matter of principle be deemed to have been provided by the CE label. The National Association of Statutory Health Insurance Funds shall assure itself of the formal lawfulness of the CE label using the conformity declaration and, where appropriate, of the certificates of the designated agency participating in the evaluation of conformity. For a given reason, additional examinations may be carried out and necessary documentation required therefor. Examinations in accordance with sentence 3 may also be carried out on the basis of random checks after the product has been included. If the examinations in accordance with sentences 2 to 4 reveal indications that provisions of the law on medical devices have not been complied with, the authorities accordingly competent shall be informed as appropriate, notwithstanding any further consequences.

(6) If the manufacturer submits incomplete application documents, it is to be granted a suitable period, which may not be more than six months in total, to subsequently provide any missing documents. The application shall be rejected if the necessary documents are not provided in full once the deadline for the decision on the application has passed. In other cases, the National Association of Statutory Health Insurance Funds shall decide within three months of submission of the complete documents. A notice shall be issued on the decision. Inclusion shall be revoked if the requirements in accordance with subsection (4) are no longer met.

(7) The proceedings to include medical aids in the list of medical aids shall be regulated by the National Association of Statutory Health Insurance Funds in accordance with subsections (3) to (6). In doing so, it may provide that it be presumed that specific requirements are met if certificates of suitable institutions are submitted or it is suitably proven that relevant norms or standards are complied with.

(8) The list of medical aids shall be regularly updated. The continuation shall comprise the further development and change to the system and to the requirements in accordance with subsection (2), the inclusion of new medical aids, as well as the deletion of products the inclusion of which has been withdrawn or revoked in accordance with subsection (6) sentence 5. Prior to a further development and to changes in the system and in the requirements in accordance with subsection (2), the national organisations of the manufacturers and healthcare providers concerned shall be afforded the opportunity to make a statement within a suitable period, and they shall be provided with the information necessary therefor; the statements shall be considered when making the decision.

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