DRGEM is pleased to announce that the company has achieved EU MDR (European Union Medical Device Regulation 2017/745) certification as of June 12, 2025.
EU MDR is a mandatory requirement for selling medical devices in Europe and is well known for its strict regulatory standards. Following a series of medical device incidents within Europe, these requirements have become much stricter. As noted in the European Parliament’s resolution (TA-10-2024-0028), MDR sets demanding standards, making it difficult for many manufacturers to achieve certification.
Despite this challenging environment, DRGEM successfully secured MDR certification by meeting all required standards. This accomplishment shows that its products meet the highest levels of safety, performance, and quality throughout their entire lifecycle, including design, manufacturing, clinical validation, and quality management.
The following DRGEM products are now certified under EU MDR:
- Diagnostic X-ray System
- Digital Diagnostic X-ray System
- Mobile X-ray System
- Digital Imaging System
- High Voltage X-ray Generator
- Rotating Anode X-ray Tube Assembly
- X-ray Collimator
These certified products are officially authorized for distribution in the European market and are recognized as compliant with global regulatory expectations. The certification further strengthens DRGEM’s global competitiveness and increases the confidence of partners and customers in its expanding product portfolio, supported by a strong global network of over 200 partners.
As a committed and reliable partner, DRGEM will continue delivering X-ray systems that not only meet clinical expectations but also comply with the most advanced international regulatory standards. The company values the ongoing partnerships as it moves forward in its mission to advance medical imaging.
