Market Access for Medical Devices in Europe: England, France, Germany, Italy, and Spain

Introduction

VIC Technology Venture Development is pleased to introduce the first installment in a new educational series on international market access for life science innovations. This white paper, developed by our strategic partner MTRC, provides a clear, practical overview of the reimbursement and regulatory environments for medical devices across five key European countries: England, France, Germany, Italy, and Spain.

For healthcare startups and their investors, the pathway to commercial success increasingly depends on access to both U.S. and international markets. Europe, in particular, presents attractive opportunities - but its complex and highly localized reimbursement systems often pose significant barriers to entry. That’s where MTRC brings unique value. As a leading European consultancy specializing in MedTech reimbursement and health technology assessment (HTA), MTRC helps companies navigate these challenges and accelerate adoption.

This partnership between VIC Tech and MTRC is designed to give VIC Tech portfolio companies a strategic edge in understanding and planning for European market expansion. By featuring MTRC's expertise in our newsletter series, we aim to provide ongoing, actionable insights that support global commercialization strategies for transformative healthcare technologies.

Market Access for Medical Devices in Europe: England, France, Germany, Italy, and Spain

MTRC Educational Series

England

Reimbursement, funding (approval by payers), and health technology assessment are three essential elements of market access for medical technologies in England.

The English health care system is financed by general taxation and is, in general, free for English citizens. The healthcare system was reformed in 2013.

The payment mechanisms for hospital, day case, and ambulatory specialist care are defined in the NHS Payment Scheme, which is approved by NHS England for one or two years (financial year starts in April).

The key payment mechanism (“aligned payment and incentive scheme”) includes fixed (global budget) and variable (activity/quality-based) components. The global budget (fixed component) is the key budget allocation mechanism for non-elective (urgent) healthcare services. The fixed budget is based on historical budgets provided and the agreed volume of activity (HRG can serve as a reference).

The role of the HRG system is limited to all elective procedures (non-urgent). HRGs are determined by a combination of a procedure (OPCS; released every three years) and diagnosis (ICD-10) codes.

Variable element of the system mostly covers elective activity and quality-based payments (using HRG tariffs).

Tariffs for day case and hospital-admitted elective procedures are the same, providing incentives for day case procedures.

Out-patient HRGs could be either procedure-driven or visit-driven (determined by the specialty).

Certain expensive medical devices are reimbursed separately from the budget system via High Cost Device List. Also, a number of diagnostic procedures are reimbursed via unbundled HRGs (which are paid/budgeted in addition to the core HRGs for care).

Innovative payment scheme

Separate funding is provided to selected NICE-approved, cost-saving technologies included in the Med Tech Funding Mandate by NHS England. Providers and commissioners have an obligation to implement technologies in the Mandate.

MedTech Funding Mandate supports devices, diagnostics, or digital products that:

Funding / commissioning

Payers are the national commissioner (NHS England, for advanced or complex procedures) or local Integrated Care Systems:

It is essential for the industry to determine the responsible commissioner, as it impacts the market access pathway and its complexity in England. Most innovative, complex procedures will fall under the category of specialized services and require approval by NHS England.

Specialized services are organized into six National Programs of Care. Each Program is supervised by the Board and has a number of supportive groups to help it develop commissioning policies. These groups are called Clinical Reference Groups (CRG). Each specialized service has a clear definition and criteria for commissioning. This is outlined in the so-called "Service Specifications." When a new procedure is suggested for national commissioning by physicians, it is first automatically granted a no-commissioning status. It is then evaluated by the relevant CRG, which develops a Clinical Commissioning Policy. This is the document that will establish the status of the technology.

Local commissioners typically maintain lists of not routinely commissioned or restricted services.

Previously, NHS England directly commissioned all specialized services. From April 2025, NHS England delegated commissioning responsibilities for 70 (out of 157) specialized services to ICBs. However, they will commission specialized services in line with national policy documents, which will be still developed by NHS England (CRGs).

Health technology assessment

Health technology assessment by NICE is very influential. NICE has several programs focused on medical devices. The most important programs are listed below.

Interventional Procedures Program

• The Interventional Procedures Program is developed for most of the novel interventional/invasive procedures entering the English market. The program focuses solely on clinical evidence. Recommendations may vary from "for research only" to "for use with standard arrangements for clinical governance, consent, and audit". Recommendations are not binding, although they are followed by providers and commissioners (especially by local commissioners).

Diagnostic Assessment Program

• A complex assessment program for diagnostic tests and technologies. The program focuses on both clinical and cost-effectiveness. Recommendations are not binding.

Medical Technologies Guidance

• The program focuses on the identification and assessment of cost-saving technologies. It considers clinical effectiveness and cost analysis. Evidence requirements are lower compared to other programs at NICE. Recommendations are not binding, but they can be a substantial asset when promoting technology in England.

In July 2025, NICE implemented significant changes in its methods and processes, including the scope of the HTA programs and approach to evaluation and recommendations. A new HealthTech program was implemented to combine the former Diagnostic Assessment and Medical Technologies guidance and the Interventional Procedures Program.

The HealthTech program will produce two types of guidance:

• HealthTech guidance for diagnostics, medical devices, and digital technologies;
• Interventional Procedures guidance (the scope and methods remain).

A life-cycle approach will be utilized for assessment and recommendations: early use, routine use, and existing use (late stage assessment).

France

Reimbursement is the key aspect of market access for medical technologies in France. HTA is not presented as a stand-alone concept and is included in the reimbursement pathway for medical devices and procedures. France also has several innovative payment schemes.

France has a mandatory health insurance system in place (Bismarck model). The payers are three statutory health insurance schemes: General statutory health insurance scheme (the most important one), Agricultural statutory health insurance scheme, and Scheme for self-employed people.

Reimbursement

Reimbursement for hospital and day case procedures are made solely via the DRG system, which is called "Groupe Homogène de Malades" (GHM). All hospitalizations, as well as day case procedures and ambulatory treatments, are mainly reimbursed via DRG; however, reimbursement of simple outpatient procedures is also possible via the fee-for-service (FFS) model and specific packages.

The DRG system has two primary components:

Diagnosis-related groups

• DRGs for hospitalizations in the French system have four severity levels, from level 1 (lowest severity) to level 4 (highest severity). The severity level is determined by the length of the stay, the presence of complications, the type of procedure performed, etc.;
• DRGs are determined by the combination of a procedure code (CCAM) and a diagnosis code (ICD-10). There is no defined schedule for the release of CCAM nomenclature. Typically, it takes 4-5 years to add a new procedure code to the system;
• DRG tariffs differ between public, private not-for-profit, and private for-profit hospitals. Private for-profit hospitals have lower tariffs, but physicians practicing there receive a fee for every procedure performed based on fees determined for each CCAM code;
• DRGs for short-stay,day case and some ambulatory procedures often have similar tariffs to DRGs for hospital-admitted procedures (thus, incentivizing day case procedures).

Add-on reimbursement (LPPR list)

• This is an add-on reimbursement mechanism for selected implantable (Title III) or invasive non-implantable (Title V) devices;
• Add-on reimbursement is available in the form of brand-specific or generic reimbursement categories;
• The LPPR list is primarily managed by the French National Authority for Health (Haute Autorité de Santé, HAS). The industry can either make a brand-specific or a generic application to request the inclusion of its products into the LPPR List. The application for a generic reimbursement is simple and does not require any clinical or economic evidence;
• The HAS performs a thorough health technology assessment of brand-specific applications. The National Committee for the Evaluation of Medical Devices and Health Technologies (CNEDiMTS) at HAS determines Actual Benefit (SA) and Added Clinical Value (ASA) for each submitted technology;
• Actual Benefit (SA) is determined on the basis of the risk/benefit ratio, the position of the device in the therapeutic strategy, and public health benefit. The device can have either sufficient or insufficient Actual Benefit. If the Actual Benefit is insufficient, evaluation is stopped, and add-on reimbursement is not granted;
• Added Clinical Value (ASA) is determined in relation to a comparable product, procedure or service, considered to be the current gold standard according to available scientific data. Added Clinical Value is classified into five categories ranging from I (major improvement) to V (no improvement). The level of Added Clinical Value will determine the price negotiated for a device. CNEDiMTS also determines specific indications for reimbursement;
• Technologies for which evidence is considered sufficient are included in the LPPR List, and their reimbursable price is determined at the national level via negotiation between a manufacturer and Economic Committee on Healthcare Products (CEPS) – a specific inter-ministerial commission.

The DRG system is approved annually, while LPPR List is updated continuously.

The DRG system is administered by the Technical Agency for Hospital Information (Agence technique de l'information sur l'hospitalisation, ATIH). Neither the industry nor the providers have a direct impact on the development of the DRG system.

In ambulatory settings, specialist procedures are reimbursed using a fee-for-service mechanism via CCAM classification. Each CCAM code has a nationally defined tariff.

Innovative payment schemes

France has several innovative payment schemes for medical technologies, which give an opportunity for early access to the French market. The most commonly considered programs are listed below.

Forfait Innovation (national innovation funding)

• The objective of the program is to provide early support for breakthrough innovation and bridge serious evidence gaps simultaneously;
• The pathway includes a government-co-sponsored study. The budget comes from three sources: the Ministry of Health (experimental arm), regular statutory health insurance (control arm), and an applicant (study infrastructure). In the process, the applicant (manufacturer) develops an application submitted to the Ministry of Health and the National Authority for Health (HAS). After evaluation and negotiations, the funding can be granted.

Program for Medical Economic Research (PRME)

• The objective of the PRME program is to support the initiatives of French hospitals to validate the clinical and health-economic value of innovative medical technologies, procedures and drugs. The program includes the performance of the study, fully sponsored by the French government;
• The program only considers products for which their clinical effectiveness and safety have been demonstrated before in French or international studies. Eligible products are at the stage of initial distribution and marketing.

Germany

Reimbursement is the key aspect of market access for medical technologies in Germany. In rare situations, funding (approval for coverage within statutory health insurance by the Federal Joint Committee, G-BA) plays a role as well. Germany also has a number of innovative payment schemes for medical technologies and procedures.

Germany has a statutory health insurance system (Bismarck model). The main payers in the system are statutory and private sickness funds.

Reimbursement for hospital procedures is made solely via a German-diagnosis-related group (aG-DRG) system. All cases of hospitalization with at least one overnight stay are reimbursed via DRG. Day cases and out-patient care are completely separate from hospital care provisions and are reimbursed via the fee-for-service model (according to the EBM catalog within the statutory health insurance).

The DRG system has the following components:

Diagnosis-related groups

• DRGs are determined by the combination of a procedure code (OPS) and diagnosis code (ICD-10-GM). OPS nomenclature is maintained by the BfArM Cologne Office (ex DIMDI) and released annually;
• Most DRGs have a national tariff, which is determined by the administrator of the DRG system, the Institute for the Hospital Remuneration System (InEK);
• Since January 1, 2020, the nursing staff costs of the hospitals are excluded from the DRG case flat rates and financed in parallel to the DRG case flat rates using a hospital-specific care budget based on the principle of cost coverage. As a result, the DRG tariffs are formed of a sum made of the tariff for the case and the tariff for the nursing care, which differs depending on the DRG and the length of stay.

Add-on reimbursement (Zusatzentgelt, ZE)

• Add-on reimbursement is provided for expensive devices, procedures, and drugs;
• ZE might or might not have a national tariff.

The G-DRG system is approved annually.

Innovative payment schemes

Germany has a number of innovative payment schemes for medical devices and procedures. Two key schemes are reviewed below.

Innovation funding for new diagnostic or therapeutic methods (Neue Untersuchungs- und Behandlungsmethoden; NUB)

The scope of the program is innovative technologies causing significant extra costs that are not covered by existing DRG tariffs. The selection of technologies is made by the Institute for the Hospital Remuneration System (InEK) according to the inclusion criteria (see below). A positive decision by InEK does not indicate that reimbursement is provided. Rather, it gives applying hospitals permission to enter into negotiations with local healthcare payers (Sickness Funds). Applications must be submitted separately by every hospital, and NUB funding will only be available to hospitals that negotiated successfully. The amount of NUB funding is not decided by InEK but is determined through negotiations. Each NUB funding agreement is only valid for one year but can be renewed annually.

Hospitals can apply for NUB innovation funding via a standardized form on InEK’s website by October 31^st of each year. InEK releases its decision about the NUB status on January 31^st. Negotiations between hospitals and sickness funds take place between April and June. The whole process, from application to reimbursement, requires around eight months.

InEK publishes the results of the NUB assessment as one of 4 possible statuses (the most common are status 1 – criteria are fulfilled and status 2 – criteria are not fulfilled).

An additional procedural rule exists for procedures including the use of so-called “high-risk medical products” (i.e., class IIb or III, active implantable and especially invasive products). Since 2016, these procedures must undergo an early benefit assessment by the Federal Joint Committee (G-BA) to obtain innovation funding (regulated in §137h of the Social Code Book V; SGB V). The hospital making the first application for such a procedure must send additional information to the G-BA, which assesses it with support from the Institute for Quality and Efficiency in Healthcare (IQWiG). If existing scientific evidence is not sufficient, the G-BA might induce a clinical study that it co-sponsors together with the manufacturer.

According to §137h (6) SGB V, manufacturers can request a judgment by the G-BA on whether their product classifies as a high-risk or especially invasive product. This possibility has been used ten times up to the present, and in six cases, the procedure in question was not eligible for the §137h SGB V framework; in three cases, it was eligible, and in one case, the consultation was not completed.

The InEK considers the following criteria when evaluating the eligibility of a method for NUB funding:

Government-co-sponsored studies according to the §137e of the German Social Code Book V (Erprobungsstudie)

Co-funded studies in Germany are regulated in §137e of the Social Code Book V (SGB V). The framework applies to diagnostic or therapeutic methods that show a potential medical benefit but for which available evidence is not sufficient to decide on inclusion as a benefit within statutory health insurance. Specific criteria described below define which methods are eligible for co-funded studies.

Co-funded studies can be induced through direct applications by manufacturers (§137e (7) SGB V) or in the process of a method evaluation by the Federal Joint Committee (G-BA). The latter can be early benefit assessments for innovation funding of high-risk devices (§ 137h SGB V) and method evaluations of outpatient procedures (§ 135 SGB V) or inpatient procedures (§ 137c SGB V).

To directly apply for a co-funded study, manufacturers file an application form including a systematic literature review, an outline of a suggested study, and a letter of intent of cost contribution. The G-BA then tests if the method in question is eligible for a co-funded study and develops a study directive specifying the key characteristics of the study, including indication, intervention and comparison intervention, endpoints, study type, observation period as well as material, personnel, and other requirements. The G-BA collaborates with the Institute for Quality and Efficiency in Healthcare (IQWiG). Before releasing the study directive, the G-BA calls hospitals that are using the method to provide additional information and then invites interested parties to make comments or suggestions.

In the next step, an independent research institute is contracted via public tender. The institute is responsible for developing the study protocol, scientific supervision of study conduction, and analysis of the data. Based on the results of the co-funded study, the G-BA, with the support of IQWiG, decides upon the inclusion or exclusion of the method as a benefit in statutory health insurance. Evaluation results only apply to the sector defined in the scope of the evidence creation.

While the evidence is collected, a note is made by the G-BA in the Directive for methods in inpatient settings or outpatient settings specifying the terms of use of the method until a final assessment is made.

Funding

Apart from the “benefit assessment” framework in connection with the NUB submission (as described above), G-BA can perform the assessment of different treatment methods (for example, based on the request from the sickness funds). This typically involves health technology assessment by the Institute for Quality and Efficiency in Health Care (Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen, IQWiG). The results of assessments are summarized in the form of Directives by G-BA.

Italy

Reimbursement is the key aspect of market access for medical technologies in Italy. Health technology assessment plays a certain role in the adoption of medical technologies at the regional level.

Italy has a National Healthcare System, which is based on general taxation.

Unlike many other countries in Europe, the Italian healthcare system is highly decentralized. The National Ministry of Health has a general policy-making role. It also supervises the development of the DRG system and tariffs. At the regional level, the Regional Health Authorities are responsible for the organization and management of the healthcare system. Actual payers in the system are Local Health Firms (ASLs). Regional Health Authorities determine the tariffs for health care services at the regional level.

Reimbursement

The reimbursement model for Italian hospital and day case activities includes a combination of DRG and a global budget.

Reimbursement of hospital care in Italy depends on the “ownership” status of hospitals:

• AO hospitals (Aziende Ospedaliere) are quasi-independent “hospital companies” which use DRGs to invoice ASLs (Local Health Companies);
• ASL-run hospitals are directly managed by the ASLs and are allocated a global budget from the ASL to pay for services provided.

Italy does not have its own DRG system and adopted the CMS DRG version 27. The system is very rigid at the national level, with no updates made since the adoption of the DRG system. DRGs are determined by the combination of a procedure code (ICD-9-CM from the 2007 year) and a diagnosis code (ICD-9). Procedure codes have not been updated since 2007, and many innovative technologies cannot be appropriately coded in the Italian system.

There are three different types of DRG tariffs in Italy:

Regions can adjust reimbursement tariffs and can innovate on the structure of the DRG system. This includes the creation of DRG sub-categories (DRG split mechanism) or add-on reimbursement for expensive procedures or devices. DRG split mechanism is introduced in two regions, and add-on reimbursement mechanism is introduced in 13 regions.

Regions differ in terms of their activity with the establishment of local payment mechanisms. Northern regions are much wealthier and typically are more active in the creation of additional payment mechanisms.

Outpatient services are reimbursed via regional reimbursement catalogs of reimbursable services, which are based on the ICD-9-CM classification. Each procedure code is associated with a tariff.

Health technology assessment

A broad network of regional, university- and hospital-based health technology assessment bodies exists in addition to the national HTA agency AGENAS. However, in a given year, only one or two regional agencies produce HTAs for medical technologies in addition to national assessments. Recommendations of HTA can have some impact on the adoption of technologies at the regional level and procurement decisions.

Spain

Spain does not have a functioning reimbursement model as hospitals mostly receive a global budget to provide services within the agreed scope. Certain medical technologies can benefit from inclusion in the Common Package of Benefits provided within the NHS. Health technology assessment plays a certain role in the adoption of medical technologies at the regional level.

Spain has a regionalized healthcare system under the umbrella of the National Health System (NHS). In total, 17 Autonomous Communities have autonomy in the organization and financing of health care services.

Payment model

There is no functioning reimbursement system for public healthcare providers. Hospitals receive funding through a global budget from regional authorities.

There are several categories of covered population in Spain, for which reimbursement models slightly differ:

• General public – covered by the NHS. Services are funded using a global budget principle;
• Specific groups of citizens – this includes public servants, military and judicial branch workers. These groups of people are covered by specific Mutual Funds (MUFACE, MUGEJU, and ISFAS respectively). Mutual Funds maintain price lists, which are used for reimbursement of services, provided to their covered population outside Spain (when they travel);
• Foreigners and citizens with private insurance – in this case, individual insurance companies have confidential agreements with providers of care.

DRG-based reimbursement is limited only to inter-regional payments (Cohesion Fund scheme) or payments by not insured population (e.g., foreigners).

Funding

One relevant aspect of market access in Spain is the inclusion of a procedure or implant into the Common Package of Benefits of the NHS.

The decision to include new technologies in the package of benefits is made by the Interterritorial Council of the NHS upon the proposals submitted by the Commission on Benefits, Insurance and Financing and the (mandatory) technical advice of the Spanish Network of Agencies for the Evaluation of Health Technologies and Benefits.

Only a limited number of technologies are admitted annually to the Package (less than ten), therefore this pathway is of limited relevance for most of novel medical technologies.

Health technology assessment

Health technology assessment is implemented at national (Instituto de Salud Carlos III, ISCIII), regional (in Andalusia, Aragon, Basque Country, Canary Islands, Catalonia, Galicia, and Madrid), and hospital levels in Spain.

Recommendations of HTA can have some impact on the adoption of technologies at the regional level and procurement decisions. Also, HTA is a mandatory part of the introduction of a technology or procedure to the Common Package of Benefits of the NHS at the national level.