All Products Meet Applicable Health, Safety, and Environmental Requirements
G&H Orthodontics is now Medical Device Regulation (MDR) certified in the European Union*. 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. 20% of manufacturers reported that they will not invest to recertify to EU MDR.
G&H’s two certificates – one for its quality management system and one for its products – are among the first 100 in the world. As an MDR-certified company, G&H can continue to ensure a supply of high-quality, trusted orthodontics products to doctors and their patients.
“This is the result of two-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.”
Since September 2020, G&H has dedicated more than 30,000 hours and invested millions of dollars to achieve MDR certification. These investments further position G&H as an authority and solutions provider in the orthodontic community.
Check out the video below to hear John talk about why this is so important for suppliers, doctors and their patients.
A Commitment to Helping Doctors Provide the Best Patient Care
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 has a long history of developing brackets, wires, elastomers, aligners and attachments. With 22,000 products now MDR certified, G&H 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.”
Get Prepared Now for MDR Compliance
This is the time to identify alternative suppliers for certified products and sample their products. Don’t be left without the products you need when your manufacturers and vendors choose not to recertify.
Contact G&H today to sample our comprehensive portfolio and find potential replacement options before your products disappear from the EU market.
* G&H Orthodontics is the commercial name for G&H Wire Company. In December 2022, G&H Wire Company achieved EU MDR certification.
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