i-dental Now EU MDR Certified

We’re now officially certified under the European Union Medical Device Regulation EU MDR (MDR 2017/745). This means our quality system and products have been independently reviewed and meet current EU requirements for safety, performance, and traceability.

Our certifications confirm compliance with the strictest European and international standards for design, manufacture and final inspection of non-sterile dental restorative and endodontic materials:

• ISO 13485:2016 – Quality Management System (Certificate No. MD 654577). Notified Body: BSI Group The Netherlands B.V., Notified Body No. 2797.
• EU MDR (Regulation (EU) 2017/745) – EU Quality Management System (Certificate No. MDR 790107). Notified Body: BSI Group The Netherlands B.V., Notified Body No. 2797.
• UK MDR 2002 (UKCA) – Full Quality Assurance System (Certificate No. UKCA 790178). Approved Body: BSI Assurance UK Ltd., Approved Body No. 0086.

i-dental devices bear the CE 2797 and UKCA 2797 markings, issued by our Notified and Approved Bodies – one of the most respected conformity assessment bodies worldwide.

To ensure compliance with UK MDR 2002, i-dental has designated Premium Plus UK Limited (Bournemouth, UK) as its UK Responsible Person (UK REP), acting as the official point of contact with the MHRA.

For our partners and clinicians, this is more than regulatory compliance. It is a guarantee that every i-dental product is safe, reliable, and manufactured under the strictest quality supervision.