TÜV SÜD presents CE Certificate under the EU MDR to Ainex

October 30, 2026

ENAD CADx, an AI-powered diagnostic support software for colonoscopies, has completed conformity assessment under the EU Medical Device Regulation (MDR). TÜV SÜD reviewed the documentation supporting the software’s safety and performance, as well as its risk management, software development and quality management systems, to support its market entry in Europe.

On 29 October, TÜV SÜD, a global testing and certification organisation, presented the corresponding CE certificate to Ainex Corporation (Ainex) for ENAD CADx, an AI-powered diagnostic support software for colonoscopy developed by Ainex, after completing the conformity assessment under the European Union Medical Device Regulation (MDR). Ainex specialises in artificial intelligence (AI) for gastrointestinal endoscopy. The conformity assessment covered the documentation supporting the software’s safety and performance of the software, as well as its risk management, software development, and quality management systems.

The CE certificate confirms that ENAD CADx has undergone the applicable conformity assessment under the EU MDR. Representatives of TÜV SÜD and Ainex attended the certificate presentation ceremony. Patrick Vollmer, CEO of TÜV SÜD AG, and Dirk von Wahl, CEO of TÜV SÜD North Asia, also attended to congratulate Ainex on successfully completing of the conformity assessment.

ENAD CADx is an AI-based software medical device that analyses lesion characteristics identified during colonoscopy in real time, assisting clinicians with diagnosis. It classifies lesions into three categories – neoplasm/adenoma, hyperplastic polyp, and sessile serrated lesion – and presents the results to support clinical decision-making.

As part of the conformity assessment under the MDR, TÜV SÜD conducted a comprehensive review of the documentation supporting the safety and performance of ENAD CADx, as well as its risk management, software development, and quality management systems. The assessment covered the MDR requirements applicable to the device and its intended use.

According to Ainex, ENAD CADx is the first AI-powered diagnostic support software for colonoscopy in Korea to complete the MDR conformity assessment and obtain a CE certificate. In September 2025, ENAD CADx passed the integrated review for innovative medical devices conducted by Korea’s Ministry of Food and Drug Safety (MFDS), becoming the first endoscopy AI solution in Korea to establish a basis for reimbursement. The CE certificate enables Ainex to pursue market access in the EU, in addition to its existing presence in more than seven countries.

Drawing on its expertise in medical device testing and certification, TÜV SÜD supports manufacturers in addressing global regulatory requirements and accessing international markets. The organisation conducts independent third-party conformity assessments for a wide range of medical devices, including AI-based software. This helps manufacturers demonstrate conformity with applicable regulatory requirements and supporting the safe introduction of innovative technologies into the market.

Download Press Release

Press contact: Dirk Moser-Delarami