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Eckert & Ziegler Receives MDR Certification for Prostate Seeds, Paving the Way for Long-term Supply
21.03.2024 / Eckert & Ziegler BEBIG GmbH, subsidiary of Eckert & Ziegler SE with focus on brachytherapy solutions for the treatment of prostate cancer as well as eye and brain tumors, obtained the MDR certificate for its proprietary prostate seeds from DEKRA Certification B.V. as one of the first companies in its market. This important milestone guarantees a high level of patient safety and the long-term availability of the seeds within the EU.
The Medical Device Regulation (MDR) is a European Union directive (EU 2017/745) with the aim of improving the quality of medical devices and increasing patient safety. Prostate seeds have been manufactured and internationally marketed by Eckert & Ziegler since 1999 and contribute several million euros in annual sales to the Eckert & Ziegler Group's earnings.
"We are very pleased about the first successful MDR certification. It confirms that our quality management system and the prostate seeds comply with the stringent requirements and that we can continue to provide them to our users as a safe medical device. This is not only a significant achievement for the distribution of our brachytherapy products, but for the entire Eckert & Ziegler Group," explained Katrin Antonenko, Managing Director of Eckert & Ziegler BEBIG GmbH. "We are already working intensively on the certification of our other medical products in order to ensure patient care for further applications in the long term. We will benefit from the experience gained from the successful approval process."
In prostate seed brachytherapy, pinhead-sized implants are inserted directly in the prostate. Due to the proximity of the radiation source to the tumor, the surrounding healthy tissue is spared as much as possible in this minimally invasive radiation procedure.
About Eckert & Ziegler.
Eckert & Ziegler SE with more than 1.000 employees is a leading specialist for isotope-related components in nuclear medicine and radiation therapy. The company offers a broad range of services and products for the radiopharmaceutical industry, from early development work to contract manufacturing and distribution. Eckert & Ziegler shares (ISIN DE0005659700) are listed in the TecDAX index of Deutsche Börse
Eckert & Ziegler Receives MDR Certification for Prostate Seeds, Paving the Way for Long-term Supply
