Chicago, Illinois-based EDGe Surgical has announced that it has received a CE Certificate of Conformity for its EDG® Ortho 65mm single-use electronic depth gauge.
The EDG Ortho is a single-use electronic depth gauge designed to replace the standard depth gauge. It has a hook design, a digital display for depth measurement, and comes in sterile packaging.
According to its website, the electronic depth gauge was designed to “improve surgical outcomes in orthopedic procedures.” Namely in procedures where a gauge is necessary to measure the depth of screw holes.
EDGe Surgical CEO Christopher Wilson discussed the EDG Ortho 65mm electronic depth gauge with OTW. “The Ortho EDG 65mm electronic depth gauge is the first and only single-use electronic depth gauge on the market.”
Wilson continued, “It has a number of advantages over legacy reusable metal depth gauges: superior hook design, digital measurement, a measurement hold feature, and improved ergonomics/usability. Studies have shown that Ortho EDG 65mm is more accurate, and because it is a single-use device, the risk of infection from bioburden contamination is mitigated.”
EDGe Surgical will now be able to expand into areas that accept CE marked medical devices. It also gives EDGe Surgical an opportunity to pursue relationships with manufacturers who have not yet transitioned to the European Union (EU) Medical Device Regulation (MDR). Per EDGe Surgical’s press release, under the MDR, “traditional metal depth gauges will be reclassified to a higher, riskier classification and must be certified by a ‘notified body’ instead of self-certification by the manufacturer.”
According to the European Commission, the MDR will “replace the existing medical devices [d]irective” and “active implantable medical devices [d]irective.” It was published in May 2017 and its four year transitional period ends on May 26, 2021.
Wilson explained, “Preparing for the requirements under the new MDR is placing significant resource strain on large orthopedic manufacturers, and some have made the tough decision to discontinue certain products due to lack of readiness.”
Wilson continued, “Our EDG Ortho electronic depth gauge is a readily available option for manufacturers that are having difficulty transitioning their legacy metal depth gauges to the more stringent requirements.”
