A peer-reviewed study published in Frontiers in Medicine in January 2026 concludes that the EU Medical Device Regulation (MDR, Regulation (EU) 2017/745) would not meet its own requirements if assessed as a regulated product. The paper, authored by Martin Haimerl, Michael D'Agosto, Mike Fornefett, Massimo Kubon and Thomas Schiepp, applies standard product development principles to the MDR itself and finds the regulation lacks measurable objectives, traceable requirements, and evidence of validated effectiveness. EUDAMED, a central pillar of the MDR, was incomplete and unvalidated when the regulation became applicable, yet manufacturers cannot place a device on the market without all essential accessories being available and functional. The European Federation of Prosthodontic and Dental Prosthetic Dental Professionals (FEPPD) connects these academic findings to practical problems faced by dental laboratories across Europe. Custom-made dental device producers operate under a framework designed around industrial serial manufacturing, which creates disproportionate compliance burdens without corresponding safety gains. FEPPD also points to the unresolved debate over whether chairside CAD/CAM production by dentists triggers manufacturer obligations under the MDR, as an example of the definitional inconsistencies the study identifies. Until the MDR is evaluated and corrected against its own principles, dental laboratories carry the compliance burden of a framework that does not apply equivalent discipline to itself.