Miltenyi Biotec reaches important milestone in the transition to EU’s new Medical Device Regulation

CliniMACS® Reagents certified as first Class III products under the stricter EU framework, already ensuring product availability well before expiry of the transition period in May 2024.

Bergisch Gladbach, Germany, July 27, 2022 - Miltenyi Biotec, a global provider of products and services for biomedical research and cellular therapy, today announced the Class III certification of all its CliniMACS® Reagents for clinical-scale cell separation under the new European Regulation EU 2017/745 on medical devices (Medical Device Regulation; MDR). These reagents support a wide variety of cell processing applications and play an integral role in cell and gene therapies such as stem cell transplantation. With their certification, a total of 90% of all Miltenyi Biotec medical devices are now certified under the MDR, ensuring prompt availability throughout the European Union.

Miltenyi Biotec always strives to provide clinical products that meet the highest standards. Therefore, the company constantly monitors its quality and manufacturing processes in order to apply the most up-to-date and compliant procedures. “We have made every effort to quickly adapt our Quality Management System (QMS) and processes to the stricter MDR-requirements,” says Paul Reister, Group Leader Regulatory Affairs Teterow at Miltenyi Biotec. “Thanks to this, we will be able to complete the transition of all MDR-relevant products well before the end of the transition in May 2024, so ensuring continuous product marketability.” In October 2020, the TÜV confirmed MDR-conformity of the company’s QMS, the first product certificates followed immediately afterwards.

The company has already been able to certify most of its products under all MDR risk classes – from Class I (lowest risk) to Class III (highest risk) – including instruments, reagents, tubing sets, adsorbers, and buffers. “The complexity and scope of the MDR audit and off-site review of technical documentation has significantly increased compared to the former directive 93/42/EEC on medical devices (Medical Device Directive, MDD). Especially for Class III products the evaluation according MDR  asks for much more data, for example, in terms of biocompatibility or virus safety,” explains Dr. Michael Vogt, Group Leader RA Liquid Medical Devices & GMP Products at Miltenyi Biotec. “That’s why we are very proud to have successfully completed our first Class III certification under the new regulation, ensuring the continued availability of our  products, including the CliniMACS® System, our unique cell separation system for cell therapies.” Miltenyi Biotec is the only manufacturer worldwide that provides medical devices for different cell separation applications including CD34+ separation for stem cell transplantations. Thereby, the MDR-approval of its CliniMACS® Reagents portfolio plays a significant role in ensuring patient care with high quality cell separation applications.

By updating the rules for medical devices in the European Union, the Commission aimed to improve the safety of products and thereby ensure a high level of public health and patient safety. The new regulation contained significant changes to the former European legal framework MDD, like reinforcing the oversight criteria of Notified Bodies or the rules on clinical evidence, implementing a comprehensive EU database for medical devices (EUDAMED) or a traceability system based on unique device identifier (UDI) for an improved transparency – to name but a few. The MDR came into force in May 2021 after a four-year transition period. Certificates previously issued under the former MDD remain valid until May 2024 at the latest. From that time, all medical devices must comply with the new regulatory framework before they can be introduced into the European market. As of today, only 15% of all medical device manufacturers are already certified under the MDR – making Miltenyi Biotec one of the pioneers in the industry and already ensuring the marketability of its products going forward.

Learn more about CliniMACS® Reagents here.
Learn more about the Medical Device Regulation here.

About Miltenyi Biotec

Miltenyi Biotec is a global provider of products and services dedicated to supporting biomedical research and advancing cellular therapy. Our innovative solutions support research at all levels, from basic and translational research to clinical applications. Our technologies enable cell research, cell therapy and cell manufacturing solutions used by scientists and clinicians around the world. Our more than 30 years of experience span research areas such as immunology, stem cell biology, neuroscience and cancer. Today, Miltenyi Biotec employs approximately 4,000 people in 23 countries - all helping researchers and clinicians to make a greater contribution to science and healthcare.

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