The Belgian Dental Technician Association (UDB) has submitted formal input to the Federal Agency for Medicines and Health Products (FAMHP) calling for tighter enforcement of Medical Devices Regulation (MDR) requirements on dental products imported from outside the EU. The submission addresses four areas: reducing administrative burdens on small laboratories, simplifying regulatory language, ensuring uniform enforcement across all market actors, and applying full MDR compliance checks to imported devices.

The concern about non-EU imports centres on competitive fairness and patient safety. Products manufactured in third countries may face weaker regulatory oversight, giving them a cost advantage over EU-compliant manufacturers while potentially exposing patients to lower safety standards.

For dental technicians and laboratory owners, the practical stakes are direct: compliance costs continue to rise, and small enterprises operating on thin margins face closure risk if the regulatory load is not calibrated to their scale. UDB's input has been incorporated into FEPPD's formal response to the EU Commission's Targeted MDR Revision Proposal. National dental technician associations not yet affiliated with FEPPD can contact the organisation to participate in the ongoing coordination process.