On March 2, 2022 Delcath Systems, Inc. (Nasdaq: DCTH), an interventional oncology company focused on the treatment of primary and metastatic cancers of the liver, reported that on February 28 its CHEMOSAT Hepatic Delivery System received Medical Device Regulation (MDR) certification under the new European Medical Devices Regulation [2017/745/EU]. Since April 2012, Chemosat had been certified under a previous regulation, the Medical Device Directive [2007/47/EC] (MDD), which is being replaced by MDR (Press release, Delcath Systems, MAR 2, 2022, View Source [SID1234609371]).

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Achieving MDR certification entails a detailed evaluation from a designated EU Notified Body, including an audit of quality systems and a review of documentation supporting safety and performance claims for the device. MDR greatly expands upon existing MDD requirements including the level of clinical evidence supporting claims, post-marketing surveillance, database traceability, unique device identification (UDI) and increased supply chain oversight. Under MDR, CHEMOSAT’s designation has changed from a Class IIb to a Class lll medical device.