The I.f.G.V. Medical device innovation center
In the medical device area, the agreement is for new methods in which medical devices with a high risk class are to be used and for which a hospital
a fee for the remuneration of new examination and treatment methods according to § 6 paragraph 2 sentence 3 of the Hospital Fee Act (NUB fee), a systematic, mandatory and time-bound procedure for the assessment of the method by the Federal Joint Committee.
The regulations and requirements for medical devices are constantly increasing. A benefit assessment (MEDNOG) equivalent to AMNOG no longer seems far off. The NUB regulation is to be combined with a benefit assessment and the testing rule is characterized by a high level of complexity.
In general, there are many ways to get a refund for innovative medical devices. But the requirements are already high in the application. This can quickly lead to lossy miscalculations, which can have fatal financial consequences for young companies and rob the patient of useful achievements.
The I.f.G.V. Medical device innovation center has high market access expertise in the medical device area, since we divide into the strategic market access area and the patient access area.
The aim is to analyze and take the fastest possible and most successful market entry route. Here, too, we will not leave you alone with the strategy; on request, we will accompany you from the clinical trial through all instances to the final reimbursement.