OBJECTIVES:  Since 2016 new medical devices of high-risk classes IIb and III have to undergo benefit assessment according to § 137h SGB V to be included in the DRG-System. As of now, the same evidence criteria are applied as in drug benefit assessment. Objective of our research is whether drug specific criteria are also applicable to medical devices and to which extend. METHODS:  We performed a systematic literature research in Medline and Cochrane databases to identify RCTs, published between January 2015 and May 2016, using relevant MeSH and controlled terms. Since an unrestricted search for medical devices is neither practical nor feasible, we limited our search to representatives of the risk classes of interest. Therefore, catheters, surgical equipment as well as prostheses/implants, considering specific procedures, were chosen. Hits that met inclusion criteria were categorized, e.g. by sample size, medical indication, blinding, and outcomes, and study quality was assessed. RESULTS: We identified 2,320 hits from which 1,745 hits were excluded by title and abstract. Of the remaining 575 hits more than 50 % were excluded because criteria of high-risk class was not met. 312 hits presented data on catheters (182), prostheses/implants (104), and stents (26). Compared to RCT in drugs, studies where relatively small (< 50 patients). Of the publications related to catheters, 17 were blinded, four of which were double-blinded. Similar results were obtained for prostheses/implants and stents. CONCLUSIONS: Although publications were indexed as RCT, the majority of them were neither randomized nor controlled. Compared to RCTs in drugs, study size was relatively small and methodological aspects partly differed from IQWiG-accepted approaches. From a health-policy perspective, it seems advisable to adapt drug benefit assessment criteria to device specific requirements in order to properly assess the possible added medical benefit of innovative high-risk medical devices.