Richard Wolf GmbH passes MDR audit

Richard Wolf GmbH has passed the DEKRA certification audit for the new EU Medical Device Regulation.

The audit, held from January 27 to 29, confirmed that Richard Wolf GmbH complies with the European Medical Device Regulation (MDR). This makes Richard Wolf, headquartered in Knittlingen, Baden-Württemberg, one of the first medical technology manufacturers ready for the new European Medical Device Regulation (MDR, Regulation (EU) 2017/745), which comes into force in May 2020. During the MDR audit by DEKRA Certification GmbH as notified body, Richard Wolf demonstrated compliance in all relevant areas.

All European medical technology manufacturers must apply the new regulation from May 26, 2020, when the three-year transition period ends and the new MDR becomes binding for all manufacturers. The MDR replaces the previous European Medical Device Directive (MDD) and will first apply to all Class I products. During an extended transition period (until May 2024), all other medical technology products can continue to be sold with existing MDD certification.

Since the legislation was passed in 2017, Richard Wolf's interdisciplinary MDR team has been working hard to implement the requirements quickly. Being one of the first companies to pass the audit not only proves Richard Wolf's capabilities, but also shows that customers around the world can rely on the company to keep supplying the products they need. Hospital operators and purchasing associations have recently expressed concern about whether the industry can guarantee full security of supply, especially as the number of certified notified bodies is still insufficient.

"The challenges associated with the new European Medical Device Regulation (MDR) will continue. But this audit result sends a strong message to all our customers that Richard Wolf, as a long-established, experienced company, will remain a reliable partner in endoscopy, imaging and OR integration," say Co-CEOs Jürgen Pfab and Jürgen Steinbeck.