DentalMonitoring Receives EU MDR Certification

Summary: DentalMonitoring announced that its software is now certified under the European Union Medical Device Regulation 2017/745 (EU MDR) and meets the requirements for CE marking as a class IIa medical device. The company says this certification highlights its dedication to advancing dental care through innovative technology and stringent regulatory compliance.

Key Takeaways:

• DentalMonitoring Software is now EU MDR certified and fulfills the requirements for CE marking as a class IIa medical device.
• According to the company, the EU MDR sets rigorous standards for clinical evaluation, risk management, post-market surveillance, and data collection.
• DentalMonitoring achieved this certification four years ahead of the deadline, it says, demonstrating its commitment to innovation and regulatory compliance.

---

DentalMonitoring announced that the DentalMonitoring Software is now certified under the European Union Medical Device Regulation 2017/745 (EU MDR) and fulfills the requirements for CE marking as a class IIa medical device. European Medical Device Regulation 2017/745 (EU MDR) replaces the previous Medical Device Directive 93/42/EEC (MDD).

EU MDR sets more rigorous requirements for clinical evaluation, risk management, post-market surveillance, and data collection on medical devices.

According to a press release from the company, this landmark achievement underscores DentalMonitoring’s commitment to advancing dental care through cutting-edge technology and rigorous regulatory compliance. The company adds that achieving this certification 4 years ahead of the deadline demonstrates its commitment to positioning itself as an innovative, serious, efficient, and safe player in the medical field.

DentalMonitoring is a medical device software using image processing algorithms to analyze intraoral scans taken by patients using the DM app, a smartphone, and proprietary hardware. The software allows dental professionals to remotely monitor dental treatments, orthodontic treatments, oral health, and treatment progress. The medical device software aids attending in diagnosis and treatment planning through weekly clinical updates.

Philippe Salah, CEO and co-founder of DentalMonitoring, said, “I’m incredibly proud that DentalMonitoring has achieved EU MDR certification along with US/FDA DeNovo 510k clearance. These achievements celebrate our relentless pursuit of innovation and excellence in oral care. Our AI-powered solutions are now recognized at the highest regulatory levels, enabling us to expand our reach and impact more lives with advanced dental technology.

“The requirements of EU MDR are much more rigorous, sometimes compelling medical device manufacturers to rethink their European commercial strategy. We are very pleased to have successfully met these requirements four years before the deadline set by the European Union. EU MDR Certification is a significant milestone that underscores DentalMonitoring’s commitment to quality, efficiency and patient safety,” said Arnaud Berthier, Director of Regulatory, Quality and Clinical Affairs at DentalMonitoring.