From 28 May 2026, manufacturers are required to register medical devices covered by certificates under the Medical Devices Regulation (EU) 2017/745 (MDR) in the European Database on Medical Devices (EUDAMED).
Mandatory EUDAMED registration will provide regulators, market operators, and stakeholders with a much clearer picture of the European dental amalgam market — including which manufacturers are active, which products are certified, and whether regulatory obligations are being met.
Dental amalgam remains a sensitive product category due to its mercury content and the strict safety, and regulatory requirements surrounding its use and placing on the market.
With EUDAMED becoming fully operational, the market will gain a new level of transparency:
- Visibility of active manufacturers across the EU market
- Traceability of certified devices and their regulatory status
- Better oversight of compliance with MDR requirements
- Increased accountability for economic operators
This creates a stronger “watchdog” function for the market and helps ensure that all manufacturers operate under the same regulatory standards.
Manufacturers of legacy devices with expiring MDD certificates (valid until 31 December 2028) are expected to register them by 28 November 2026. All certificates should be uploaded by 28 May 2027.
The coming months will therefore be critical — not only for compliance, but also for improving transparency.