Germany expands the scope of early benefit assessments and strengthens requirements for co-funded studies

On 15 October 2026, the German Federal Joint Committee (G-BA) adopted amendments to its Rules of Procedure governing early benefit assessments of new examination and treatment methods under §137h SGB V and co-funded studies under §137e SGB V. The amendments will enter into force on the day following their publication in the Federal Gazette, but no earlier than 3 November 2026.

The amendments introduce two main changes: a broader scope for early benefit assessments and more extensive obligations for applicants involved in studies intended to generate additional clinical evidence.

Changes to Early Benefit Assessments under §137h SGB V

The amendments expand the scope of early benefit assessments and clarify the assessment criteria and procedural timelines.

Key changes include:

• Broader scope: The procedure will cover all new examination and treatment methods that are not predominantly based on the administration of medicinal products, provided the remaining statutory eligibility criteria are met.
• Recognition of potential: Methods may be recognized as having the potential to serve as necessary treatment alternatives if they could replace more invasive, resource-intensive, or insufficiently effective approaches, reduce adverse effects, or improve treatment outcomes.
• Defined timelines: For methods with insufficient evidence of benefit but recognized potential, the G-BA must establish quality requirements within three months and decide on a study Directive under §137e SGB V within six months.
• Revised reference date: The historical cut-off date of 1 January 2016 for identifying first-time NUB inquiries will be replaced by the day preceding the entry into force of the amended Rules of Procedure.
• Manufacturer agreement: For methods substantially based on medical devices, hospitals submitting information must obtain the agreement of the relevant device manufacturer.

Changes to Co-Funded Studies under §137e SGB V

The amendments also strengthen the financial, contractual and procedural requirements for applicants participating in co-funded studies.

Key changes include:

• Financial commitments: Applicants must formally acknowledge their statutory cost-bearing obligations and commit to financing independent scientific oversight, study evaluation and appropriate compensation for participating healthcare providers. Failure to confirm these obligations within two months may result in termination of the procedure.
• Study documentation: Applicants must submit a study concept demonstrating compliance with the study Directive and confirm that their agreement with the independent scientific institution meets regulatory requirements.
• Progress reporting: Participating manufacturers and companies must inform the G-BA about study initiation and patient recruitment progress.
• Withdrawal and termination: Applicants may withdraw before study commencement. The G-BA may terminate manufacturer-financed studies that have not begun within 18 months of the study Directive's adoption.
• G-BA funding: The G-BA may independently decide to conduct and finance a study, although applicants have no legal entitlement to such funding.

What does it mean for the industry?

The amendments have important implications for manufacturers of medical devices used in new examination and treatment methods in Germany. The broader scope of §137h may bring additional technologies into early benefit assessment, while the revised criteria clarify how methods with insufficient evidence of benefit may qualify for further evidence generation. At the same time, the changes to §137e introduce more explicit financial, contractual and reporting obligations for manufacturers involved in co-funded studies.

Manufacturers should assess whether their technologies fall within the revised scope of §137h and review the potential implications for their evidence-generation and market-access strategies. Companies considering participation in §137e studies should also evaluate the financial commitments, study preparation requirements, and implementation timelines before initiating the relevant procedures.

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