MDR certification verifies that G&H Orthodontics has met the most current EU regulatory requirements for its full portfolio of products.
G&H Orthodontics announced that it is Medical Device Regulation (MDR) certified in the European Union. According to a press release from the company, fewer than 10% of all medical device companies worldwide have achieved this milestone.
This MDR certification verifies that G&H meets the most current regulatory requirements for its systems and its portfolio. All manufacturers and vendors must recertify and meet these compliance deadlines to continue distributing medical devices in the European market. According to G&H Orthodontics press release announcing its certification, 20% of manufacturers reported that they will not invest to recertify to EU MDR.
As an MDR-certified company, G&H says it can continue to ensure a supply of high-quality, trusted orthodontics products to doctors and their patients.
“This is the result of 2-plus years of intensive work from our team,” G&H CEO John Voskuil said. “Other manufacturers may have exited the market or focused only on aligners, but we are committed to a full portfolio and uninterrupted service to our customers.”
According to G&H Orthodontics, since September 2020, the company has dedicated more than 30,000 hours and invested millions of dollars to achieve MDR certification. The company says these investments further position G&H as an authority and solutions provider in the orthodontic community.
As the company puts it the MDR mandates will ultimately improve patient safety with more rigorous efficacy requirements for medical devices. As an example of one measure taken to satisfy increased product traceability, G&H now uses unique device identification (UDI) mechanisms.
G&H Orthodontics now has 22,000 MDR certified products, and says it remains dedicated to providing safe, reliable devices for the EU market and world at large.
“We’ve invested in a new plant, new equipment, and new processes so that we have the highest quality products,” Voskuil said. “Our top priority is making sure doctors have the products they need to deliver the best patient care.”