Eckert & Ziegler Achieves Key Milestone with MDR Certification for Prostate Seeds

On 21 March 2024, Eckert & Ziegler BEBIG GmbH, a subsidiary specializing in brachytherapy solutions within Eckert & Ziegler SE, announced its achievement of securing the MDR (Medical Device Regulation) certification for prostate seeds. Granted by DEKRA Certification B.V., this certification places Eckert & Ziegler among the initial few in its sector to reach such a standard. The certification underscores the company's commitment to maintaining high patient safety standards and ensures the EU market's long-term access to these implants.

Brachytherapy, specifically through the use of these prostate seeds, has been a focus for Eckert & Ziegler since 1999, providing substantial annual revenue. The MDR, an EU directive established to enhance medical device quality and patient safety, corroborates the company’s adherence to stringent requirements through this certification.

Katrin Antonenko, Managing Director at Eckert & Ziegler BEBIG GmbH, expressed satisfaction with achieving MDR certification, viewing it as a testament to the company's rigorous quality management system. The certification not only benefits the distribution of their brachytherapy products but also reflects positively on the entire Eckert & Ziegler Group. The company is also actively pursuing further certifications for its medical products to ensure long-term patient care access.

The method of brachytherapy using prostate seeds, where pinhead-sized implants are positioned directly within the prostate, exemplifies a minimally invasive procedure while preserving surrounding healthy tissue by focusing radiation closely on the tumor.