Europe is not a unified healthcare market. Reimbursement and market access pathways, responsibilities, and decision-making processes are shaped by national regulations. For international Medtech manufacturers, Germany is often the key reference market. It is the largest market in Europe, where market success is closely tied to the primary healthcare market and reimbursement.
It is important to make a clear distinction: CE certification is the prerequisite for being allowed to offer a product. Reimbursement and market access, on the other hand, determine whether and how the medical services will be financed. Obtaining reimbursement for a technology in the German healthcare market is a highly structured, rule-based process characterized by fixed timeframes. This process involves annual deadlines and procedures related to OPS codes (BfArM), DRG development applications and supplemental fees, as well as NUB applications (InEK).
In practice, these processes often span several years and have multiple phases, so missing a deadline results in an unnecessary loss of time. Planning reimbursement and market access activities approximately two years before the expected CE approval is a sound strategy.
Healthcare Heads GmbH supports international manufacturers in developing a robust market access and reimbursement strategy for the German healthcare market—from system logic to the operational preparation of the relevant procedures.
For an initial assessment of your situation and product, please contact us for a complimentary consultation.
Author: Healthcare Heads GmbH
Phone: +49 431 800 1470
E-Mail: info@healthcareheads.com