In Europe's medical devices industry, reimbursement means a form of payment made by an insurer (or "payer"), that may be of public or private nature. In this business relationship, the payer covers the costs that a healthcare provider reimburses for the use of a medical product in its practice. For that to happen, a few requirements are made, such as a presentation of clinical data that can prove the device's clinical and economic benefits.
Without the medical device reimbursement approved, or if the coverage isn't the right amount, the healthcare provider is unable to offer new technologies. That's why the precise navigation of the reimbursement system is utterly important for the success of a medical device's market entry in the EU.
Keep reading and understand how the medical device reimbursement works in Europe and learn about the various systems, regulatory requirements, and strategies for successful market entry.
How Medical Device Reimbursement Works
The reimbursement systems help not only the devices' manufacturers, but also the patients, because with that payment provider, they are ensured to have access to the medical care they need. Hospitals or physicians will purchase the device and bill for it under existing reimbursement mechanisms.
For the manufacturers, the challenge of the process is demonstrating the medical necessity and effectiveness of their devices. Companies are required to conduct specific clinical trials, which can be high cost and take some time. That's why it is important for them to know that, depending on which EU country, the criteria for reimbursement is different, meaning the process may also be different for each one.
Key Benefits of Reimbursement Systems
- Ensures patient access to necessary medical care and innovative technologies
- Provides financial support for healthcare providers to adopt new devices
- Validates clinical and economic value of medical devices
- Facilitates market entry and commercial success for manufacturers
- Establishes standardized payment mechanisms across healthcare systems
The Four Key Constituents of Reimbursement
Even with their particularities, each reimbursement process relies on the same 4 constituents:
Code
An alphanumeric sequence that identifies a device or product to facilitate communication between all parties involved in the reimbursement process.
Coverage
The criteria and conditions under which a medical device qualifies for reimbursement, determined by payers based on clinical evidence and medical necessity.
Payment Rate
The amount that payers will reimburse for the use of the medical device, determined based on cost-effectiveness analysis and budget impact.
Setting
The environment where the device will be used (hospital, ambulatory care, or patient's home). Coverage criteria, payment rate, and code will differ based on the setting.
Important Note: Depending on which environment (whether it is a hospital, an ambulatory setting, or even a patient's home) the device will be used, the coverage criteria, payment rate, and code will be different.
Starting a Medical Device Reimbursement Application
As you now know, the success of a medical device in the market is directly associated with the success of a reimbursement mechanism formalization. That's why it is recommended that the relationship between manufacturers and future payers start early in the process, so you can make sure the product has higher chances of approval.
First things first, the initial step in planning for it is to look for information on already applicable reimbursement mechanisms for your product. Don't forget to identify the settings in which the device will be used and include them in your research. In the case of previous existence of a mechanism, the reimbursement is theoretically immediately possible.
1Research Existing Mechanisms
Identify applicable reimbursement mechanisms for your product type and determine the settings where the device will be used.
2Engage with Payers Early
Establish relationships with potential payers early in the development process to understand requirements and increase approval chances.
3Prepare Clinical Evidence
Conduct clinical trials and gather data that demonstrates clinical effectiveness and economic benefits of your device.
4Submit Application
Prepare and submit comprehensive reimbursement application with all required documentation and clinical evidence.
Alternative Scenario: Developing a New Reimbursement Process
When there is no existing reimbursement mechanism for your medical device
When there is no reimbursement mechanism already working for your medical device, a thorough clinical report is required for the approval of one. This report must prove clinical and economic benefits your product offers the medical community, and set up an initial user base, relying on the support of local healthcare providers.
Strategies for Establishing New Reimbursement
- Develop comprehensive clinical and economic evidence demonstrating device benefits
- Build initial user base through partnerships with local healthcare providers
- Start at individual hospital level that can pay for new technologies
- Leverage payers and charity funds with budgets for medical innovation
- Adapt device features to fit established reimbursement mechanisms
Regarding the user base, many times, manufacturers have to start at the level of an individual hospital that can pay for new technologies, or even rely on payers and charities funds that have a budget for the medical benefit of their members.
Adapting to Existing Mechanisms
Another way to get your device to be on terms with a reimbursement mechanism is to adapt your project to fit an established one. That means to modify the device features, functionality, or specifications so it can be integrated in the process.
Device Adaptation Considerations
- Evaluate existing reimbursement categories that closely match your device
- Assess feasibility of modifying device features to fit established codes
- Maintain core clinical benefits while adapting specifications
- Ensure regulatory compliance throughout adaptation process
- Consider cost-benefit analysis of adaptation versus new mechanism development
Country-Specific Requirements in Europe
Pay attention to the requirements of each European country for medical device reimbursement
As we already said, each member country of Europe has their own criteria regarding reimbursement of a medical device. Some are easier, and some might be more complicated. That's why some countries are more "wanted" than others for entering the medical device market in the EU.
Key European Markets for Medical Device Reimbursement
France
France is the second biggest medical device market in the continent, with an obligatory social health insurance system that covers the whole population. However, it does not cover all healthcare costs; as a result, 90% of the population has chosen to acquire private health insurance that pays the remaining costs.
Germany
Germany is a preferred location that manufacturers choose for their first markets, offering a robust healthcare system and established reimbursement pathways for medical devices.
United Kingdom
The UK is also among the preferred locations manufacturers choose for their first markets, with well-defined reimbursement processes and strong healthcare infrastructure.
Factors Influencing Country Selection
- Size and maturity of medical device market
- Complexity and timeline of reimbursement approval process
- Healthcare system structure (public, private, or mixed)
- Level of innovation adoption and openness to new technologies
- Availability of clinical trial infrastructure and expertise
- Language and cultural considerations for market entry
Eclevar Gets Your Medical Device Reimbursement Ready to Launch in Europe
Eclevar MedTech is a global CRO with extensive experience in navigating European medical device reimbursement systems. Our management team with more than 20 years of experience will drive you to the effective solution and is ready to offer customized service, personalized to the needs of our clients.
How Eclevar Supports Your Reimbursement Strategy
- Strategic planning for reimbursement pathway selection
- Clinical trial design and execution to generate required evidence
- Health economic analysis and cost-effectiveness studies
- Regulatory guidance for country-specific requirements
- Payer engagement and relationship management
- Reimbursement dossier preparation and submission support
Ready to Navigate European Reimbursement?
Our team of experts is ready to help you develop a comprehensive reimbursement strategy for your medical device in Europe. Contact us to discuss your specific needs and how we can support your market access goals.
Contact Us NowKey Takeaways
- Medical device reimbursement in Europe involves payment from public or private payers to healthcare providers for device use
- Reimbursement approval is critical for market success and healthcare provider adoption of new technologies
- All reimbursement processes rely on four key constituents: code, coverage, payment rate, and setting
- Early engagement with payers significantly increases chances of reimbursement approval
- Research existing reimbursement mechanisms before developing new pathways
- Comprehensive clinical and economic evidence is required to demonstrate device benefits
- Building an initial user base through hospital partnerships can facilitate reimbursement approval
- Device adaptation to fit existing reimbursement mechanisms is a viable alternative strategy
- Each European country has unique reimbursement criteria and processes
- France, Germany, and UK are preferred markets for initial European market entry
- France has obligatory social health insurance with 90% private supplementary coverage
- Clinical trials are required to demonstrate medical necessity and device effectiveness
- Reimbursement criteria vary based on device usage setting (hospital, ambulatory, home)
- Starting at individual hospital level can provide initial market access while pursuing broader reimbursement
- Charity funds and specialized payers may support innovative medical technologies
- Expert CRO support can significantly streamline the reimbursement approval process