European Medical Device Reimbursement Consulting

See all reimbursement consulting services.

Does your medical device have CE Marking but you are struggling to increase sales? Do you need to understand the reimbursement mechanism in various European countries?

Unlike medical device regulation, there is no pan-European process for medical device reimbursement. Most countries use a system of Diagnosis Related Groups (DRGs) to set a price for a particular medical procedure, including any products that will be used in that procedure.

The authorities use Health Technology Assessments (HTA) to decide which products will be formally approved for use in a procedure, ensuring that only those medical devices shown to be clinically and economically effective are reimbursed.

However, the decision concerning which medical devices will qualify for reimbursement (and often also what price will be paid) by the government or patient’s health insurance provider is driven by local government health care policy. As such, there can be considerable variation in the medical device reimbursement approval process and data requirements from country to country. Additionally, the processes can be subject to regulatory changes as countries reform their respective health-care systems and budgets in line with their current policies.

Emergo Group's EU offices have experience with medical device reimbursement systems in several European countries. Our EU reimbursement consulting services include: