A peer-reviewed study published in Frontiers in Medicine in January 2026 concludes that the EU Medical Device Regulation (MDR, 2017/745) would not pass the requirements it imposes on manufacturers, if assessed by its own criteria. The authors, Haimerl et al., applied established product development and good regulatory practice principles to the MDR itself, examining whether it defines measurable objectives, ensures traceability, and validates its own tools and infrastructure. Their conclusion: it does not.

For dental laboratories producing custom-made devices, this finding reinforces long-standing practical concerns. The MDR was designed around industrial serial manufacturing, and applying that framework without adjustment to bespoke dental technology creates proportionality gaps and legal uncertainty. EUDAMED, central to MDR operation, remained incomplete and unvalidated for years after the regulation entered into force, precisely the kind of design-to-implementation failure the regulation forbids in manufacturers.

FEPPD draws a direct line from the academic findings to its own documented concerns, including the JAMS 2.0 inspection analysis, which showed that joint market surveillance activities largely overlooked the specific risk profile of dental laboratories, and the ongoing manufacturer definition debate around chairside CAD/CAM production. For dental labs, the practical consequence is continued administrative burden under a framework whose own governance does not consistently meet the standards it enforces.