Which route gets MedTech and IVD reimbursed by German statutory health insurance when CE marking says nothing about payment?
We map the reimbursement route for MedTech and IVD: NUB payment, § 137h SGB V assessment, a § 137e trial or the medical aids directory. Payment is decided by hospitals, sickness funds and the G-BA in separate procedures, not by the notified body.
Overview
Which procedures decide whether statutory health insurance pays for a medical device?
Reimbursement routes for MedTech and IVD · § 6(2) KHEntgG, §§ 135, 137c, 137e, 137h and 139 SGB V
Last updated: October 3, 2026
CE marking under the MDR or IVDR allows a product to be placed on the market. Whether German statutory health insurance pays for its use is settled in social-law procedures, and which one applies depends on the care setting and on the product's role in the method.
- In inpatient care, diagnostic and treatment methods may be used as part of hospital treatment under the conditions of § 137c(3) SGB V, in particular where they have the potential of a necessary treatment alternative and are applied according to the rules of medical practice. This does not automatically entail separate payment.
- A new method that diagnosis-related group (DRG) rates do not yet reflect adequately is paid through a time-limited NUB payment under § 6(2) KHEntgG. The hospital requests the information from InEK by October 31 at the latest, and the payment is agreed between the hospital and the sickness funds locally.
- Under § 137h SGB V as rewritten by the GKV Contribution Rate Stabilization Act, the hospital submits the state of knowledge to the G-BA with the first NUB request for a method that does not rest solely on a medicinal product; where the method relies decisively on a medical device, in agreement with the manufacturer and with complete study data. This extension only applies once the G-BA's amended rules of procedure are in force, and the G-BA expects this not before October 31, 2026. Until the amended rules of procedure take effect, the previous scope for new diagnostic and treatment methods using high-risk-class medical devices continues to apply under the G-BA's procedural resolution of September 17, 2026.
- Office-based care follows the opposite logic: under § 135(1) SGB V, a new method may only be provided after a G-BA recommendation, and the application is filed by the impartial members, the Associations of Statutory Health Insurance Physicians or the National Association of Statutory Health Insurance Funds, not by the manufacturer.
- Medical aids enter the medical aids directory under § 139 SGB V on the manufacturer's application; the manufacturer must show functional suitability, safety, the quality requirements and, where necessary, medical benefit.
Services
How we support you
NUB Requests Prepared with Hospitals
Method description and costing basis for the NUB request to InEK under § 6(2) KHEntgG, aligned with the requesting hospitals, because the request is filed there and not by the manufacturer.
G-BA Consultation and Trial Application
Preparing the consultation under § 137h(6) or § 137e(8) SGB V and an application for a trial guideline under § 137e(7), including which independent scientific institution will accompany the trial.
How we work together
What it comes down to
There is no single reimbursement route for medical devices and diagnostics in Germany, and the care setting decides which one applies.
In hospitals, the use of new diagnostic and treatment methods is governed by § 137c SGB V. Payment is generally made through the hospital remuneration system. Where a new method cannot yet be paid appropriately through the existing DRG rates and supplementary fees, separate NUB payments may be agreed under the conditions of § 6(2) KHEntgG. In office-based care, it is the other way around: under § 135(1) SGB V, the method first needs a G-BA recommendation.
Between the two sits the method assessment under § 137h SGB V. The GKV Contribution Rate Stabilization Act rewrote its paragraph 1 as of July 30, 2026: it no longer turns on high-risk-class devices but on any new method that does not rest solely on a medicinal product; as before, the G-BA only assesses where the method has a new theoretical and scientific concept.
The broader scope only applies once the G-BA's amended rules of procedure are in force, and according to its procedural resolution of September 17, 2026 the G-BA expects this not before October 31, 2026; until the amended Rules of Procedure take effect, the old scope remains.
That is why we fix the route first and the documents second: who files the request, which data must be complete, and whether a trial under § 137e SGB V is the more realistic path. Digital applications are reimbursed through the DiGA directory, and selected high-risk devices also face the Joint Clinical Assessment.
Our approach
Our approach
Step
Result
Set care setting and procedure
Decided whether the product enters care in hospitals, office-based practice, as a medical aid or as a digital health application, and which body decides in each case.
Hold evidence against the procedure
The available clinical data compared with what the chosen procedure requires, for example the complete study data under § 137h(1) SGB V.
Consult before the procedure
A prepared consultation with the G-BA on requirements and trials or, for novel medical aids, with the National Association of Statutory Health Insurance Funds on the application documents.
Request and documents
The hospitals' NUB request by October 31, the information package for the G-BA or the application to the medical aids directory, depending on the route.
Payment and follow-on procedures
Support for hospitals in the payment negotiation and trial planning when the G-BA finds potential but does not yet consider the benefit proven.
Common pitfalls
Where projects commonly fail
CE marking is equated with eligibility for reimbursement.
It is a prerequisite for placing the product on the market lawfully, but it does not establish any entitlement to payment by statutory health insurance. Whether and by which route reimbursement follows depends on the relevant provisions of social insurance law.
The manufacturer plans the NUB request as if filing it itself.
Under § 6(2) KHEntgG, the hospital obtains the InEK information by October 31 at the latest; without requesting hospitals, there is no payment.
§ 137h SGB V is read in its old version, or as if the new one already applied in full.
Since July 30, 2026, the wording of paragraph 1 no longer turns on the high risk class but on any method that does not rest solely on a medicinal product; as before, an assessment only follows where the concept is new. Under paragraph 1 sentence 8, however, the new first sentence only applies once the amended rules of procedure are in force, and according to its procedural resolution of September 17, 2026 the G-BA expects this not before October 31, 2026; until the amended Rules of Procedure take effect, the previous scope for new diagnostic and treatment methods using high-risk-class medical devices continues to apply.
Study data are submitted selectively.
Where the method relies decisively on a medical device, the information under § 137h(1) SGB V includes complete data on the clinical studies performed, and the G-BA assesses on that basis within three months.
Outpatient use is planned without a G-BA recommendation.
Under § 135(1) SGB V, a new method may only be charged to the sickness funds in office-based care after that recommendation, and the assessment can run for up to two years.
Market Access, RWE & Reimbursement
Do any of these pitfalls apply to you?
In a first call we assess your situation and say what needs clarifying first in your case. Without obligation, reply usually within one working day.
FAQ
Frequently asked questions
Sources
- Krankenhausentgeltgesetz (KHEntgG), § 6(2): primary text, gesetze-im-internet.de
- German Social Code Book V (SGB V), §§ 135, 137c, 137e, 137h and 139: primary text, gesetze-im-internet.de
- GKV Contribution Rate Stabilization Act of July 24, 2026, BGBl. 2026 I No. 228, Article 1 Nos. 56b and 56c, Article 6a and Article 8
- Regulation (EU) 2021/2282 on health technology assessment, Art. 7: primary text via the EU Cellar
- Commission Implementing Regulation (EU) 2025/2086 of 17 October 2025 (joint clinical assessment of medical devices and IVDs): primary text via the EU Cellar (CELEX 32025R2086)
- Federal Joint Committee (G-BA), procedural resolution of September 17, 2026 on the amendment of § 137h SGB V by the BStabG, resolution text and rationale: g-ba.de/beschluesse/8019
Image notice: The images on this page were generated using artificial intelligence. They do not depict real people, places, or events.
Life Science Journal
Regulatory updates, straight to your inbox.
New requirements, authority decisions and practice notes. Once a month, unsubscribe any time.
Projects from this industry
What we have worked on in this industry
Latest insights
All insights →Regulations & standards considered
- Krankenhausentgeltgesetz (KHEntgG, Hospital Remuneration Act), § 6(2) (payment for new diagnostic and treatment methods)
- § 137h SGB V (assessment of new diagnostic and treatment methods involving high-risk-class medical devices; official heading, paragraph 1 rewritten by the GKV Contribution Rate Stabilization Act)
- § 137e SGB V (trials of diagnostic and treatment methods)
- § 137c SGB V (assessment of diagnostic and treatment methods in hospitals)
- § 135 SGB V (assessment of diagnostic and treatment methods in office-based care)
- § 139 SGB V (medical aids directory)
- Regulation (EU) 2021/2282 (EU HTA Regulation), Art. 7(1)(c) and (d)
- Implementing Regulation (EU) 2025/2086 (procedural rules of the joint clinical assessment for medical devices and IVDs)
Related topics
Pricing & Reimbursement →
Price and reimbursement across medicinal products and devices
HTA Dossier →
Assessment documents for G-BA, IQWiG and European procedures
DiGA Approval →
The separate reimbursement route for digital health applications
Joint Clinical Assessment →
The joint clinical assessment for selected high-risk devices
Have a concrete project?
Briefly outline your situation. We'll respond with an initial assessment, usually within one business day.
Prefer direct? +39 02 8904 1000
info@theentourage.it
- Reply usually within one working day
- 4 offices: DE · CH · IT · US
- 100% life sciences