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 the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR), with particular focus on imports from outside the European Union.

The submission addresses four areas: reducing administrative burden on small laboratories and individual enterprises, simplifying regulatory language to avoid pharmaceutical-style complexity, ensuring uniform enforcement across all medical device actors, and applying full MDR compliance checks to dental devices imported from non-EU countries. UDB argues that weaker oversight in third countries creates unfair competitive conditions and risks to patient safety.

The UDB contribution has been incorporated into an updated FEPPD formal response to the EU Commission Targeted MDR Revision Proposal, which was discussed at a recent FEPPD Members Zoom meeting. Dental technician associations across Europe that are not yet FEPPD members can contact the organisation to participate in the ongoing coordination process.