Flyer Medical Devices

3 Market access for medical devices Good products alone are no longer enough these days. They must also be recognized and known as such. This applies both to the prescribing physicians, the actual service providers, and to all other stakeholders involved in supply and reimbursement decisions. Only then will there be fewer problems with market access for a new product. In addition, market access increasingly differs between pharmaceuticals and medical de- vices. In addition, the regulation of medical devices is becoming more sophisticated and complex. The introduction of new evaluation procedures for medical devices of higher risk classes (IIB and III) via sections 137e and f of the German Social Code, Book V (SGB V) has greatly increased the reimbursement hurdles for these products. The NAVIGATOR Medical Devices enables the "distributor" of an innovation to better assess the opportunities and risks and the pros and cons for his medical device for market access in the different care segments, outpatient or inpatient and with the different payers, GKV, PKV, BG, rehabilitation or long - term care insurance and consequently to select the optimal market access. Differences between the clinic and the doctor's office Different framework conditions and regulatory mechanisms apply to reimbursement in the outpatient care sector than in the inpatient sector. In the outpatient care sector, permission is required, i.e. an innovative product may not be launched on the market without the per- mission of the Federal Joint Committee, for example. The situation is different in the inpatient care sector, where the prohibition proviso applies. As long as no authorized institution has prohibited the use of an innovative medical product, it is considered permitted. As a general rule, drugs must be reimbursed and medical devices can be reimbursed by the health insurance funds.  Prohibition reservation in inpatient care  Reservation of permission in outpatient care  Consultation hour need, relevant for many dressing means  Aids catalog according to § 139 SGB V and fixed amounts for aids  Procedures according to paragraph 137e and f SGB V  Special paths via direct contracts and model projects or individual case decisions