EU Reimbursement for Medical Devices CE Mark approval is only the first step to market entry, reimbursement is key and most time consuming part in some cases. Approval is important within the EU, however, reimbursement of each member state is generally the most critical factor in product success (Gomez 2003). While approval of medical device products has become standardized within the EU, reimbursement is still determined by each country separately (Lewington 2003). While the CE Mark is recognized throughout the union, procedures for filing for reimbursement and reimbursement levels vary widely across the EU member countries (Marchant 2003). A further complication for manufacturers is that reimbursement decision making in many EU markets is not national, it is regional or local (Kinsbergen 2000). In addition all countries in Europe have restrictive reimbursement lists, referred to as positive lists and negative lists. The positive lists are for products that have reimbursement and the negative are for products that do not have reimbursement (Lewington 2003). As reimbursement is becoming a popular target for cost containment measures there is increasing pressure to remove products from positive reimbursement lists as well as pressure to reduce existing reimbursements. Copyright © 2004 Kirk Zeller, All rights reserved