Sun Nuclear Announces Completion of Transition to CE Class IIb EU MDR Certification for Key Quality Management Solutions

MELBOURNE, Fla.--(BUSINESS WIRE)--Sun Nuclear, a Mirion Medical company, announced today that its SunCHECK^® Quality Management software and key radiation therapy Quality Assurance (QA) devices have been awarded CE Class IIb certification under the European Medical Devices Regulation 2017/745 (EU MDR). The transition to EU MDR Class IIb recognizes the safety and performance of Sun Nuclear solutions and confirms compliance with stringent safety requirements.

Sun Nuclear solutions awarded Class IIb certification include:

• The SunCHECK^® Platform, a comprehensive software application facilitating essential Patient and Machine QA workflows and centralized data management;
• Patient-specific QA solutions, including the ArcCHECK^®, ArcCHECK^®-MR, MapCHECK^® 3 and SRS MapCHECK^® devices, for measurement of radiation dose distributions against planned doses;
• Machine QA solutions, including the Daily QA™ 3, Daily QA™ 3-MR, IC PROFILER™, IC PROFILER™-MR devices, for routine QA of linear accelerators used in treatment delivery; and
• Beam Dosimetry, Scanning and Commissioning solutions, including: the 1D SCANNER™ and SunSCAN 3D™ water tanks; the PC Electrometer™ for absolute dose calibration and EDGE™ Detector for small-field beam modeling; and SNC125c™, SNC350p™ and SNC600c™ reference ion chambers.

“For 40 years, Sun Nuclear devices and software have helped radiation oncology and medical physics teams confidently adopt new technologies and techniques, enhance workflows, and improve patient care,” said Luis Rivera, president of Sun Nuclear and executive vice president of Mirion Medical. “The transition to Class IIb EU MDR certification reinforces our commitment to safe, efficient, and effective cancer treatment globally, and further positions the company for ongoing success in Europe.”

The Sun Nuclear portfolio will be featured in booth #280 at ESTRO 2025, May 2-6, in Vienna, Austria. ESTRO 2025 is the annual congress for the European Society for Radiotherapy and Oncology and includes Europe’s largest industry exhibition in radiation oncology.

About Sun Nuclear

Sun Nuclear is part of Mirion Medical, a group of healthcare-focused brands within Mirion, providing innovative solutions for Radiation Therapy and Diagnostic Imaging. More than 6,000 cancer centers worldwide rely on us for independent, integrated Quality Management. With a focus on ongoing support, Sun Nuclear aims to ease technology adoption, enhance workflows and improve outcomes – so that healthcare providers can achieve real results for Patient Safety. Learn more: sunnuclear.com.