Germany is the largest medical device market in Europe, and its reimbursement system is the entry exam for serious MedTech revenue on the continent. Three frameworks govern how a device gets paid for: the statutory health insurance system (GKV) that covers roughly 90 percent of the population, the DRG case-based system that pays hospitals for inpatient episodes, and the NUB procedure that creates a temporary payment channel for genuinely new examination and treatment methods. A CE mark gets the device onto the market. None of these three frameworks cares about the CE mark by itself. Reimbursement is a separate, parallel track with its own evidence requirements, its own committees, and its own multi-year timelines — and startups that do not plan for it burn their runway on regulatory work and then discover there is no revenue waiting on the other side.

By Felix Lenhard and Tibor Zechmeister. Last updated 10 April 2026.

TL;DR

  • Germany has the largest statutory health insurance market in Europe. The GKV covers the large majority of the population through a system of statutory sickness funds, and the rules about what GKV pays for are set nationally, not by individual funds.
  • Hospital inpatient care is reimbursed through the German DRG system — a case-based flat-rate system where each inpatient episode is mapped to a diagnosis-related group that carries a defined payment weight.
  • New technologies that do not yet fit an existing DRG rate can apply for an NUB status through the InEK (the German DRG institute) to receive temporary, hospital-negotiated additional payment while evidence is built.
  • Outpatient care under the GKV is paid through the EBM catalogue, where every reimbursable service has a code. If there is no code, there is no reimbursement — and getting a new code is a multi-year process through the Federal Joint Committee (G-BA).
  • The gap between CE marking and actual reimbursement in Germany is typically measured in years, not months. Planning for this gap is the difference between a device that ships and a device that sells.

Why German reimbursement is the real market access question

A CE mark is a permission slip. It says the device may be placed on the European market. It does not say anyone will pay for it. In a private-pay market that distinction can be papered over with pricing creativity. In Germany, where the statutory health insurance system sits at the centre of almost every clinical decision, the distinction is the entire business model.

Founders arrive in Germany with a CE-marked device and discover that the question hospitals actually ask is not "is this certified?" but "how does this get billed?" If the answer is "it does not yet," procurement stops. The cleanest technology demonstration in the world cannot override the hospital's need to cover its own costs. The German reimbursement system is not hostile to innovation. It is a sequencing system, and the sequence is long.

Understanding GKV, DRG, NUB, and the outpatient EBM structure is not optional background reading for a German launch. It is the framework that decides whether the device reaches paying customers in year two after CE or year six. The difference is usually whether the company survives.

The German healthcare system at a glance

Germany has a dual insurance structure. The statutory health insurance system, GKV (Gesetzliche Krankenversicherung), covers around 90 percent of the population through a network of statutory sickness funds. The remaining roughly 10 percent are covered by private health insurance, PKV (Private Krankenversicherung), which operates under different contracting and pricing rules. For a MedTech startup trying to reach scale in Germany, the GKV is the market that matters. Private insurance is an adjacent channel, not a substitute.

Within the GKV, coverage decisions are not made by individual sickness funds. They are made centrally by the Federal Joint Committee — the Gemeinsamer Bundesausschuss, G-BA — which is the self-governance body that decides what the GKV pays for and under what conditions. The G-BA issues directives that bind every statutory sickness fund. Pricing of inpatient services flows through the InEK (Institut für das Entgeltsystem im Krankenhaus), which calculates the annual DRG catalogue. Pricing of outpatient services flows through the EBM, the uniform assessment standard for outpatient care, which is negotiated between the national association of statutory health insurance physicians (KBV) and the federal association of statutory health insurance funds (GKV-Spitzenverband).

The consequence for a device company is that there is no single counterparty to negotiate with. Getting a device reimbursed in Germany means engaging a system of interlocking bodies, each with its own timelines and evidence thresholds, and understanding which track the device belongs to. The track depends on the clinical setting — inpatient, outpatient, hospital-based new method, digital health — and each track has a different gate.

GKV: the statutory health insurance system

The GKV is the payer. For a medical device to produce durable revenue in Germany, it must eventually be covered by GKV — either directly, as part of a reimbursed procedure, or indirectly, as part of a reimbursed case in a hospital. Coverage is not automatic. The G-BA decides what the GKV pays for, based on evidence of benefit, medical necessity, and cost-effectiveness relative to existing options.

For devices that fit into existing reimbursed procedures, GKV coverage is inherited. A surgical instrument that replaces another surgical instrument in an already-reimbursed procedure typically does not need its own coverage decision — it is paid for as part of the procedure. This is the easiest path, and most Class I and many Class IIa devices live here. Market entry is a question of hospital procurement and clinical adoption, not reimbursement policy.

For devices that introduce a new procedure, a new treatment method, or a new diagnostic workflow, GKV coverage is not inherited. A new coverage decision is required. In the inpatient setting, that decision runs through the DRG system and potentially NUB. In the outpatient setting, it runs through the G-BA's evaluation process for new examination and treatment methods — known as NUB in the outpatient context as well, and regulated through G-BA procedures for Neue Untersuchungs- und Behandlungsmethoden. The thresholds are strict, the timelines are long, and the evidence package typically includes clinical trial data that goes well beyond what the MDR required for CE marking under Regulation (EU) 2017/745, Article 2(1) and the clinical evaluation provisions.

The practical lesson is that MDR compliance produces a certified device. It does not produce a reimbursed device. These are two separate evidence packages built for two different audiences, and underestimating the second one is the single most common German market entry failure among MedTech startups.

DRG: how inpatient care is paid for in Germany

German hospitals are reimbursed for inpatient episodes through the German DRG system — a case-based flat-rate system where every inpatient stay is coded, classified into a diagnosis-related group, and paid at a nationally defined weight multiplied by a base rate. The system is managed by the InEK, which publishes an updated DRG catalogue each year and adjusts weights based on the previous year's cost and case data submitted by German hospitals.

For a device company, the DRG system creates two different situations. The first is that the device fits inside an existing DRG. The hospital buys the device, uses it, bills the DRG, and absorbs the device cost inside the flat rate. Whether the hospital makes or loses money on that case depends on whether the device cost fits under the DRG weight. If the device is cheap relative to the DRG, hospitals adopt it readily. If the device is expensive relative to the DRG, hospitals cannot afford to adopt it without additional payment — and this is where the NUB procedure becomes relevant.

The second situation is that the device enables a procedure that does not fit any existing DRG. In that case, the hospital cannot bill for the case at all, or can only bill a DRG that does not reflect the true cost of the new procedure. Without a pathway to either a revised DRG weight or a separate additional payment, adoption will not happen regardless of clinical value. This is where the NUB status created by § 6 Absatz 2 KHEntgG — the hospital financing law — becomes the bridge.

NUB: the bridge for new examination and treatment methods

The NUB procedure — Neue Untersuchungs- und Behandlungsmethoden — is the German mechanism for creating a temporary, hospital-negotiated additional payment for genuinely new methods that are not yet adequately represented in the DRG catalogue. The legal basis is in the hospital remuneration framework (KHEntgG), and the operational gate is the InEK.

The mechanics, at general framing: a hospital that wants to use a new method applies to the InEK by the statutory deadline each year, requesting NUB status for a specific method. The InEK reviews the applications and assigns a status — broadly, either "Status 1" meaning the method is new, the NUB criteria are met, and the hospital may negotiate an additional payment with the sickness funds for that method; or a status indicating that the method is not eligible, because it is already covered elsewhere or does not meet the newness criteria. The NUB status is granted per hospital, per year, and is always temporary. It is not a price. It is a permission to negotiate a local price, one hospital at a time, for one year at a time.

NUB is the single most important mechanism for new hospital-based MedTech in Germany because it is the only way to generate real German revenue before a permanent DRG adjustment exists. The permanent DRG adjustment, when it happens, takes years — the DRG catalogue is recalibrated annually based on cost data that the hospitals only start generating once they are using the device, which means the earliest a DRG catch-up for a new method can reach the annual catalogue is the budget year that follows the first full year of broad adoption. NUB fills the gap.

For a startup, the NUB strategy is not optional for inpatient devices that do not fit existing DRGs. Without it, there is no path to revenue that is not personal persuasion of a hospital CEO. With it, there is at least a procedural route. Specific code numbers, payment amounts, and InEK decision windows vary year to year and are outside the scope of this post — these are tracked in the InEK annual publications and should always be checked against the current version before planning is finalised.

Outpatient reimbursement through the EBM

Outpatient care under the GKV — everything that happens in a physician's office or an authorised outpatient clinic — is paid through the EBM, the uniform assessment standard. The EBM is a catalogue of services, each with a code and a point value. Every reimbursable outpatient service has an EBM code. If there is no EBM code, there is no GKV reimbursement for that service.

For a medical device used in outpatient care, the question is whether using the device produces an EBM-billable service. If the device is used within an existing EBM code — a new blood pressure monitor used as part of an already-coded examination — the reimbursement pathway is inherited, just as with DRGs in the inpatient setting. If the device introduces a new diagnostic or treatment service that no existing EBM code covers, the company needs a new code, and getting one is a G-BA procedure that runs on a multi-year timeline and requires clinical benefit evidence that goes well beyond the MDR clinical evaluation.

The EBM pathway is the gate that digital health, outpatient diagnostics, and device-enabled therapies pass through for sustained GKV revenue. It is also the gate that most startups underestimate by the largest margin. The assumption is often that "once we have CE, German doctors will use it." The reality is that German doctors cannot bill for unpaid services, and unpaid services are not sustainable practice patterns.

The multi-year timelines

The timeline from CE mark to meaningful German reimbursement for a genuinely new technology is typically measured in years. This is not a bureaucratic failure. It is the structural consequence of a system that requires clinical benefit evidence before committing public funds to a new intervention.

At general framing: NUB status can be achieved in the first year after CE mark if the application is prepared in advance and meets the InEK newness criteria, but NUB is a bridge, not a destination — it creates local, negotiable, temporary payment. Permanent inclusion in the DRG catalogue at a weight that reflects the true cost of a new method typically takes multiple cycles of cost data collection and recalibration, because InEK updates the catalogue based on actual hospital cost data. New EBM codes for outpatient services follow G-BA procedures that run on similar multi-year horizons. Digital health applications have a faster track through the DiGA system (covered separately in post 750), but DiGA is a distinct framework with its own rules, not a general reimbursement shortcut.

The planning consequence is straightforward. A MedTech startup that raises money based on "CE mark plus twelve months" as the path to German revenue has not planned for German reimbursement. The realistic plan is CE plus an NUB-bridged revenue phase plus a multi-year path to permanent DRG or EBM inclusion. Compressing this timeline is rarely possible. Ignoring it is always expensive.

What startups underestimate

The first thing startups underestimate is that reimbursement is a separate evidence package from regulatory. CE marking evidence under MDR is built to answer one question: is the device safe and does it perform as intended? Reimbursement evidence answers a different question: does this device produce a benefit that justifies public payment relative to the existing standard of care? These questions overlap but are not the same. The clinical evidence plan has to serve both from day one, or the reimbursement package has to be built from scratch after certification — at double the cost and triple the time.

The second thing startups underestimate is that NUB status is not a business model. It is a bridge. Companies that treat the first year of NUB-negotiated revenue as "working" and do not simultaneously prepare the permanent DRG or EBM pathway find themselves with no path forward when the bridge ends. NUB buys time; it does not buy durability.

The third thing startups underestimate is that German reimbursement is not transferable to other EU markets. France, the Netherlands, Italy, and Spain each have their own frameworks and their own evidence thresholds. German reimbursement unlocks Germany. It does not unlock Europe. (See post 747 on the European reimbursement landscape and post 748 on country-by-country sequencing.)

Common mistakes

  • Assuming GKV coverage is granted by the G-BA once CE marking is in place. It is not. Coverage decisions are a separate evidence process.
  • Treating NUB status as permanent reimbursement. It is a temporary, hospital-by-hospital, year-by-year bridge.
  • Building the clinical evaluation for MDR only and discovering after certification that the reimbursement package requires a different comparator, a different endpoint, or a different patient population.
  • Ignoring the EBM question for outpatient devices because "the hospital will just use it." Hospitals do not bill EBM. Outpatient physicians do.
  • Planning the German launch around a single expensive clinical champion at one academic hospital, without a plan for how the rest of the German hospital landscape will ever bill for the device.
  • Underestimating the depth of the InEK's review of NUB applications. The criteria are specific, the evidence expected is real, and a sloppy application burns a full year.

The Subtract to Ship angle

Subtract to Ship applied to reimbursement means refusing to build evidence packages that do not serve a specific, named gate. Every clinical endpoint, every cost dataset, every health economic analysis must trace to a gate: MDR clinical evaluation, NUB application, G-BA benefit assessment, DRG recalibration, EBM code request. If a piece of evidence does not serve one of these, it does not belong in the plan.

The framework also means refusing to build for every reimbursement system in parallel. Pick one gate per phase. Get through it. Then build the next one. Companies that try to build for MDR, NUB, DRG recalibration, EBM coding, and DiGA all at once end with four incomplete packages and no reimbursement anywhere. Companies that sequence — MDR first, then NUB bridge, then permanent inclusion — actually get through the gates, one at a time. This is the same discipline the Subtract to Ship framework applies to regulatory work (see post 065), applied one layer deeper into market access.

Reality Check — Where do you stand?

  1. Do you know which of the three tracks (inpatient DRG, outpatient EBM, or digital health DiGA) your device belongs to in Germany?
  2. Have you confirmed whether the device inherits reimbursement from an existing procedure code, or whether it requires a new payment pathway?
  3. If you are in the inpatient track, do you know whether your device fits an existing DRG or needs NUB status — and have you built the NUB application timeline into your launch plan?
  4. Is your clinical evaluation plan designed to serve both the MDR technical file and the German reimbursement evidence package, or only the first one?
  5. Do you have a realistic multi-year roadmap from CE marking to permanent DRG or EBM inclusion, or is your plan implicitly "CE plus twelve months"?
  6. Have you identified a German reference hospital that is both clinically willing and administratively capable of running the NUB procedure for your device?
  7. Is your runway sufficient to cover the gap between CE marking and first meaningful German revenue, without a forced gap round?

Frequently Asked Questions

Does a CE mark guarantee German reimbursement? No. The CE mark is a regulatory permission to place the device on the European market. Reimbursement is a separate decision made through the GKV framework — the G-BA for coverage, the InEK for DRG and NUB, the KBV and GKV-Spitzenverband for the EBM. Each of these has its own evidence thresholds that go beyond MDR clinical evaluation.

What is the fastest reimbursement pathway for a new inpatient device in Germany? For genuinely new inpatient methods, the NUB procedure is usually the fastest bridge. NUB status, if granted by the InEK, allows the hospital to negotiate additional payment with the sickness funds for that specific method. It is temporary, hospital-specific, and year-by-year, but it is the earliest mechanism for meaningful German revenue while permanent DRG inclusion is pursued over multiple years.

Can a startup use NUB as its long-term reimbursement strategy? No. NUB is a bridge, not a destination. It is designed to allow temporary payment while evidence is collected for permanent integration into the DRG catalogue or other reimbursement structures. A startup that relies on NUB alone, without pursuing permanent inclusion, will eventually lose the bridge and find itself without a payment pathway.

How long does it take to get a new EBM code for an outpatient service in Germany? There is no single answer, but the process runs through the G-BA and typically takes multiple years. It requires a benefit assessment, including clinical trial evidence comparing the new service to the relevant standard of care. Startups planning a German outpatient launch need to plan for this timeline explicitly rather than assuming it will happen passively after CE.

Does German reimbursement transfer to other European countries? Generally no. Each country has its own reimbursement framework, its own payer structure, and its own evidence thresholds. Germany is the largest single market in Europe but is not a gateway to automatic coverage elsewhere. A European reimbursement plan is built country by country, not through a single master approval.

Sources

  1. Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, Article 2(1). Official Journal L 117, 5.5.2017.
  2. Sozialgesetzbuch (SGB) V — the German Social Code Book Five, the statutory basis for the GKV, the G-BA, and the coverage decision framework.
  3. Krankenhausentgeltgesetz (KHEntgG) — the German hospital remuneration law, including the statutory basis for NUB applications under § 6.
  4. InEK — Institut für das Entgeltsystem im Krankenhaus — annual DRG catalogue and NUB status publications. Always check the current year's publication for up-to-date procedure codes and application deadlines.
  5. G-BA — Gemeinsamer Bundesausschuss — directives and procedural rules for coverage decisions, benefit assessments, and new examination and treatment method evaluations.
  6. EBM — Einheitlicher Bewertungsmaßstab — the uniform assessment standard for outpatient services under the GKV, maintained by the KBV and the GKV-Spitzenverband.

Current-status verification note: specific NUB codes, DRG weights, InEK application deadlines, and EBM code numbers change annually. Any operational plan built on this post must verify the current year's values directly against the InEK, G-BA, and KBV publications before commitments are made. This post intentionally frames the system at the structural level and does not cite specific code numbers or payment amounts, which would be out of date within a single budget cycle.

This post is part of the Funding, Business Models & Reimbursement series in the Subtract to Ship: MDR blog. Authored by Felix Lenhard and Tibor Zechmeister. German reimbursement is the gate that decides whether a certified device becomes a real European business, and the sequencing discipline it demands is the same discipline that gets startups through MDR in the first place.