HUGE Dental has obtained EU-MDR status!

Our company successfully obtained the first MDR certificate issued by SGS in China for both of PMMA and Zirconia dental materials.

With the continuous development of medical technology and the extensive use of medical devices, the old EU Medical Devices Directive (MDD) has gradually exposed some shortcomings in terms of the comprehensiveness and strictness of regulation, etc. 

The introduction of the  Medical Device Regulation (MDR) is very necessary, and the following are the upgraded points of the MDR compared with the MDD in the field of dental materials:

1. Regulatory Compliance

MDD: As a directive, needs EU member states to turn it into national laws.

MDR: As a regulation, directly takes effect in all EU member states, ensuring consistent regulatory requirements for dental milling materials.

2. Product Classification

MDD: Broad product classification, with some less - detailed risk assessment and classification.

3. Certification and Audit

MDD:  Simple certification process, basic technical documentation required.

MDR: Complex and strict certification. Comprehensive technical documentation needed, including R&D, risk, clinical data, etc., plus product life cycle management audit.

4. Product Traceability

MDD: Less clear and strict traceability requirements.

MDR: Stresses traceability, requires a complete medical device traceability system for quick recall.

5. Post-market Surveillance

MDD: Fewer and less intense post - market surveillance requirements.

MDR: Strengthens post - market surveillance, demands frequent and detailed product reports, strict and timely adverse event monitoring.