Market Access

CE certified – what is next?

Anyone wishing to sell a medical device in Germany requires CE approval. This approval is centrally regulated by the European Union. In 2017, the MDR (Medical Device Regulation, MDR – EU Regulation 2017/745) was introduced (replacing the MDD (Medical Device Directive, MDD – 93/42/EEC). The new MDR has been applicable since May 26, 2021.

CE approval is valid throughout Europe, but this does not mean that the European healthcare market is uniformly regulated. When it comes to reimbursement, there are sometimes dramatic differences between the individual national markets: each country has its own, sometimes highly complex reimbursement mechanisms. If you want to be successful in Europe, you need not only a consultant for Europe, but also an expert for each individual country.

Europe's diversity: Reimbursement is regulated at national level

Germany has particularly strict and differentiated regulations. A product that is already reimbursed in France or Italy may still lack various requirements in Germany—from coding to clinical and economic evidence. CE approval is therefore only the very first step. Actual market access begins after that – and is particularly challenging in Germany. It should therefore be planned for one to two years before CE approval.

The German healthcare market: extensive, complex, highly regulated

Germany is the largest healthcare market in Europe and, with annual healthcare expenditure of over €500 billion, the third largest worldwide. At the same time, the German healthcare system, which has evolved historically since the Middle Ages, is highly regulated and extremely complex due to the numerous interdependencies between the various regulatory areas.

The German healthcare market is not a free market. This means that prices and reimbursement are not determined by supply and demand, but by a multitude of laws and regulations. These regulatory mechanisms are in turn dependent on the cost structure and market segment of the various products.

Why market access and reimbursement are indispensable

In order to reach patients with a new medical device and get reimbursed, market entry and reimbursement must be prepared carefully in advance to meet all specific regulatory requirements right from the start. This includes activities in the areas of reimbursement and market access, economics, evidence, and external affairs.

Even before CE approval, manufacturers must develop a reimbursement and market access strategy for the German market. They must understand the market access mechanisms, and the different options for reimbursement of their medical device and the therapy and obtain an overview of the necessary activities.

Strategic questions for manufacturers

Manufacturers face a multitude of strategic considerations that must be considered at an early stage:

• Is there already reimbursement for the product or the underlying therapy in place?
• Is this reimbursement economically viable for the service providers?
• Is it necessary to actively influence reimbursement—for example, by applying for OPS codes, DRG development proposals, NUB applications, benefit assessment procedures, proposals for hybrid DRGs, or service groups?

What associated measures are necessary for successful market access? A well-thought-out reimbursement and market access strategy is not a short-term undertaking but typically involves a process lasting several years—depending on the type of product, indication, degree of innovation, and the chosen reimbursement route.

Healthcare Heads: Your navigator through the system

Healthcare Heads supports and guides international MedTech companies through the complex German healthcare system; we specialize in market access in Germany. With our partners, we offer all appropriate and necessary projects for the German healthcare market.

Our medical perspective and health economics expertise, combined with our experience in self-governing bodies and industrial companies, make us ideal guides through the laws, regulations, and customs of the German healthcare market. Our projects are efficient and always tailored to our clients' needs.

"We see ourselves as a navigator with a compass of medical knowledge, economic expertise, and regulatory experience. We will not only show you the direction, but also actively accompany you every step of the way—from strategy development to successful implementation."

Our mission

We want to do our part to ensure that patients in Germany always have access to the most innovative medical technologies.

We will be more than pleased to support you in positioning your products appropriately.

E-Mail: info@healthcareheads.com

Phone: +49 431 800 147 0