Pearl Becomes First AI Dental Detection Software Company to Receive EU-MDR Certification

Pearl, a provider of AI-driven computer-aided dental detection software, has achieved a significant milestone by receiving a certification recommendation as a Class IIa medical device under the European Union Medical Device Regulation (EU-MDR). 

The certification, issued by GMED SAS on June 6, 2023, makes Pearl the first company worldwide in the AI-driven computer-aided dental detection software industry to obtain the new European Medical Device Regulation (MDR) Certification recommendation.

Ophir Tanz, founder and CEO of Pearl, highlighted the significance of Second Opinion‘s EU-MDR certification, stating, “This is a major regulatory milestone for Pearl on the international stage.” 

EU-MDR: Enhancing Safety and Quality

The EU-MDR, established by the European Commission, is a medical device regulation aimed at improving the safety and quality of medical devices while ensuring transparency for patients to safeguard public health and patient safety. GMED SAS, an independent third-party certification organization based in France, conducted the necessary technical documentation reviews and audits for Second Opinion® MDR certification. This new certification supersedes the EU Medical Devices Directive (MDD) certification previously awarded to Second Opinion in 2021.

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Pearl’s Second Opinion utilizes computer vision and machine learning technologies to assist dentists in automatically detecting a wide range of dental conditions in radiographs of permanent teeth, including bitewing, periapical, and panoramic radiographs of patients aged 12 and older. 

Cambron Carter, co-founder and CTO of Pearl, emphasized the significance of the EU-MDR certification, stating, “The EU-MDR is one of the world’s most robust health tech regulations, and it plays a vital role in ensuring medical devices meet the highest standards.” 

Rigorous Testing to Meet Regulation Standards

To obtain the Class IIa classification, Pearl underwent rigorous evaluations to demonstrate that its Second Opinion solution and quality management system met the EU-MDR’s stringent standards for safety and effectiveness. This involved external audits, submission of technical documentation, and presentation of clinical benefits and studies for review by GMED SAS.

While the EU-MDR certification is specific to Europe, Pearl’s quality management system, as certified by GMED, adheres to multiple global standards to ensure medical software quality and safety. Furthermore, Pearl has reportedly obtained regulatory clearances for Second Opinion in over 100 countries, affirming its commitment to meeting international regulatory requirements and expanding its reach in the global dental market.