The European Union’s Medical Device Regulation (EU MDR) introduces significant changes that directly impact dental devices and their manufacturers. Many products are being reclassified into higher-risk categories (e.g., some implants shifting from Class IIa to IIb) while custom-made devices such as crowns, bridges, and aligners must now meet more stringent requirements. In addition, strict enforcement of country-specific language rules is reshaping labeling and data submissions to EUDAMED.
At the same time, other global regulators (including Australia and Brazil), are advancing their own Unique Device Identification (UDI) requirements. These overlapping changes present both challenges and opportunities for dental device companies.
On 9th December, join the Dental Trade Alliance, in partnership with Loftware and USDM Life Sciences, for an insightful webinar on ‘EUDAMED Compliance for Dental Devices: Navigate MDR, UDI, and Global Labeling Requirements with Confidence’. Together, these organizations will share deep regulatory, product identification and cloud compliance expertise to aid dental device manufacturers navigate EUDAMED and global UDI with confidence.
