Ulm, April 2021. TÜV Süd has issued ulrich medical with the official MDR certificate for its Class Ir devices, thereby confirming that the Ulm-based medical technology manufacturer has a quality management system compliant with the new EU Medical Device Regulation (MDR). This means that security of supply with ulrich medical devices is already assured before the MDR officially becomes applicable on May 26, 2021.
Originally, the MDR was to become fully applicable and binding for all manufacturers on May 26, 2020, after a three-year transition period. However, as a result of the Covid-19 pandemic, the start of validity of the MDR was postponed by a year to May 26, 2021. Medical devices with valid MDD certification can continue to be placed on the market during the extended transition period until May 2024.
The significantly increased documentation and stricter testing criteria in comparison to the old EU directive, plus mandatory clinical trials, have been the center of attention for the internal MDR competence team ever since 2017. This strategic focus by ulrich medical has been instrumental to the company’s success in achieving MDR certification. “The numerous requirements under the MDR will continue to keep us busy on an ongoing basis. But we’re now excellently equipped to push on with certification of the rest of our product portfolio”, says Klaus Kiesel, Managing Director of ulrich medical.
Security of supply is assured
Many market players are still wondering how medium-sized companies in the medical technology sector, in particular, will be able to handle the stricter regulatory requirements and increased documentation involved.
“We’re proud that, thanks to the successful aligning of our processes to the MDR specifications, we already have the coveted certificate at this point. This is further proof of the quality and safety of our products. It also means that we have now assured the security of supply of ulrich medical devices, and once again we are a reliable long-term partner to our end users and distributors across the globe”, says Christoph Ulrich, Managing Partner of ulrich medical.
ulrich medical continues to provide information on all the latest MDR news on its website and social media channels.
About ulrich medical
ulrich medical develops, produces and distributes cutting-edge medical technology that makes a significant contribution to health and quality of life. Since the founding of the family-owned company in Ulm in 1912, medical professionals and users worldwide have valued the expertise of this independent company. As a renowned specialist for spinal systems and contrast media injectors, ulrich medical is committed to the “Made in Germany” quality label, making it one of the few companies in the industry that consistently develops and manufactures its products in Germany. The implants for spinal systems, which are mainly made of titanium, are used for injuries and diseases affecting any part of the spine, and they are well established internationally. In the field of contrast media injectors for CT and MRI, ulrich medical offers specially developed user solutions that support radiologists with modern diagnostic imaging. The user-friendly handling, excellent quality and proven hygienic safety of the contrast media injectors make them indispensable in everyday practice, and were a decisive factor for gaining coveted approval in the world’s largest medical technology market, the USA. ulrich medical is one of the first medical device manufacturers in Germany to have been successfully MDR-audited. In addition, the F.A.Z. Institute named ulrich medical one of the “Innovation Leaders of Germany 2020”.