Sun Nuclear Achieves EU MDR Class IIb CE Certification for Key QA Solutions
Sun Nuclear, a Mirion Medical company, announced that its SunCHECK® software and key radiation therapy quality assurance (QA) devices have successfully completed the transition to CE Class IIb certification under the European Union Medical Device Regulation (EU MDR 2017/745). This milestone validates the performance, safety, and compliance of Sun Nuclear’s offerings with the EU’s most rigorous medical device standards.
The newly certified devices and software are essential to the quality management of both patient and machine-based processes in radiation therapy. The CE Class IIb certification is one of the highest regulatory classifications under the EU MDR and is reserved for medical devices that play a critical role in sustaining life or preventing significant patient harm. Sun Nuclear’s successful transition confirms that its solutions meet stringent performance and safety standards necessary for continued distribution in the European market.
Certified Products
Several of Sun Nuclear’s flagship products received the Class IIb certification:
- SunCHECK® Platform: A comprehensive quality management software system that supports routine quality control processes for both patients and machines. It also offers centralized data management for streamlined clinical operations.
- Patient-Specific QA Solutions: These include devices like ArcCHECK®, ArcCHECK®-MR, MapCHECK® 3, and SRS MapCHECK®, all of which are used to verify radiation dose distributions against treatment plans, ensuring accurate and safe therapy delivery.
- Machine QA Solutions: Tools such as the Daily QA™ 3, Daily QA™ 3-MR, IC PROFILER™, and IC PROFILER™-MR provide routine performance checks on linear accelerators, which are critical to delivering precise radiation doses.
- Dose Measurement and Commissioning Solutions: This category features the 1D SCANNER™, SunSCAN 3D™ water tanks, PC Electrometer™, EDGE™ Detector, and SNC125c™, SNC350p™, and SNC600c™ reference ion chambers, all designed for dose calibration, small-field modeling, and scanning needs.
Commitment to Quality and Safety
“For four decades, Sun Nuclear has supported radiation oncology professionals by providing tools that advance safety, improve workflow, and enable the adoption of new technologies,” said Luis Rivera, President of Sun Nuclear and Executive Vice President of Mirion Medical. “Achieving EU MDR Class IIb certification not only demonstrates our ongoing commitment to clinical excellence but also secures our ability to support cancer care providers throughout Europe.”
Global Impact and Industry Presence
The certification strengthens Sun Nuclear’s position in the European market, enabling continued distribution of its high-impact QA tools and software. Globally, over 6,000 cancer centers trust Sun Nuclear’s independent quality management solutions, which play a critical role in maintaining high standards in radiation therapy.
To highlight its recent achievements and showcase its certified technologies, Sun Nuclear will be exhibiting at ESTRO 2025, the annual meeting of the European Society for Radiotherapy and Oncology. The event, which takes place from May 2 to 6, 2025, in Vienna, Austria, is the largest of its kind in Europe for professionals in the radiation oncology field. Sun Nuclear will be present at booth 280, where attendees can explore its range of certified QA solutions and engage with its team of experts.
About Sun Nuclear
Sun Nuclear, part of the Mirion Medical group, focuses on delivering advanced QA and diagnostic imaging technologies for radiotherapy. As a key player in the Mirion portfolio of healthcare brands, Sun Nuclear combines decades of experience with a forward-thinking approach to patient safety and workflow optimization.
Their mission is centered on enabling seamless technology adoption, improving treatment accuracy, and supporting better clinical outcomes. With a reputation built on reliability and innovation, Sun Nuclear continues to drive quality standards across the radiation therapy industry.
