Medical Device & Drug Reimbursement FAQs

How long does it take to obtain reimbursement?

The first step is to determine whether your medical device fits within an existing reimbursement mechanism (coding, coverage and payment rate), or in the case of a drug, whether it fits within a group of comparable pharmaceutical products for which reimbursement prices have already been set. This assessment is typically performed as part of our Step 1: Reimbursement Landscape report.

If your product fits within an existing reimbursement mechanism or product group, reimbursement can often be obtained almost immediately.

If no existing reimbursement mechanism or product group applies, developing a new reimbursement pathway may take several years. The timeline depends on factors such as the product’s clinical benefits, the political and economic environment, and country-specific reimbursement policies. However, even in these cases, interim or short-term reimbursement mechanisms are often available, allowing some level of reimbursement to be achieved within months.

For practical examples, please refer to our Resources page. You may also find our Synchronizing Reimbursement and Regulatory Activities presentation helpful for a visual explanation of this process.

How much does it cost?

The cost of a reimbursement project varies depending on several factors, including the type of product, the target country or countries, and the specific reimbursement environment involved.

To receive a tailored business proposal that reflects your company’s needs and objectives, please request a free quote. A Mediclever representative will contact you shortly to discuss your project in more detail.

Where should we start? In which country should we launch our first reimbursement project?

Most of our clients typically begin their reimbursement efforts in the United States, Germany, and the United Kingdom, followed by France, Italy, and Spain as second-tier markets.

Key criteria for selecting an initial market include overall market size, reimbursement complexity, expected timelines, and the strategic importance of the country for future expansion.

When should we start looking into reimbursement issues?

Reimbursement planning should begin as early as possible and ideally be integrated throughout the product development lifecycle:

Activity 1 – Reimbursement Landscape: This step should be conducted as early as possible, as it may influence the overall reimbursement strategy, product features, intended indications, target markets, and the overall regulatory strategy.

Activity 2 – Evidence Planning: This activity should be completed prior to initiating Phase III clinical studies, as reimbursement requirements may impact clinical trial design and evidence generation.

Activity 3 – Implementation: Implementation activities typically begin a few months before the planned product launch.

For further reading, we recommend the following articles: Reimbursement Strategy DO’s and DON’Ts and Synchronizing Reimbursement and Regulatory Activities .

Our product is already reimbursed in the USA. Will it help us obtain reimbursement in Europe?

In general, there is no formal link between reimbursement systems in the United States and European countries. Reimbursement decisions are made independently at the national level.

That said, European decision makers are increasingly receptive to high-quality reimbursement and health economic data generated in other countries, particularly when it is relevant to local clinical practice and payer priorities.

Is reimbursement in Europe similar for all EU countries?

No. While regulatory approval in Europe is harmonized through the CE marking process, reimbursement remains a national responsibility.

Each European country maintains its own reimbursement mechanisms, assessment criteria, and decision-making bodies. As a result, reimbursement obtained in one European country does not imply reimbursement in another.

We have an excellent distributor that we count on. Should we let them handle our reimbursement needs?

A distributor with reimbursement experience may be helpful in identifying existing reimbursement mechanisms. However, distributors should not define a company’s overall reimbursement strategy or submit reimbursement applications independently.

What makes Mediclever’s reimbursement consulting services better?

• Two decades of drug and medical device reimbursement consulting

  Our extensive experience consistently translates into measurable results for our clients.

• Deep reimbursement consulting expertise

  We bring together a network of trusted reimbursement experts across the U.S. and Europe, including former payer medical directors, public policy specialists, health economists, and life science executives.

• Proven track record

  We have successfully guided hundreds of life science clients, helping them secure new reimbursement codes, expand coverage policies, and achieve sustainable market access.

• Broad scope of services

  We assume full responsibility for the entire reimbursement process, from strategy development through implementation. This includes:

  • Development of a preliminary reimbursement strategy
  • Guidance for the development of a reimbursable product
  • Synchronization of regulatory and reimbursement strategies
  • Adjustment of clinical development plans to support reimbursement
  • Early validation with payer representatives
  • Applications for new codes, appropriate payment rates, and favorable coverage policies
• Flat fees and concrete timelines

  Before we begin working together, you will know exactly what the reimbursement process will entail, how long it will take, and how much you will spend in consulting fees.

Which countries do you cover?

We have experience and local experts to address reimbursement in each of the following countries: