Align Technology receives Class IIa certification for Invisalign system
Align Technology, a medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, has seen its Invisalign system and Vivera retainers certified by the European Union as Class lla medical devices.
The certification is based on evidence compiled and reviewed by DEKRA Certification B.V., an independent external EU notified body and certification body for medical devices.
As part of the review process, DEKRA, one of the world’s largest independent safety monitoring, inspection, and certification companies, conducted an extensive review of Align’s technical files, including clinical evaluation and risk management, and completed a thorough quality audit of the company’s production processes. The certification signifies that the product design of the Invisalign system and Vivera retainer meet the general safety and performance requirements of council directives 93/42/EEC and 2007/47/EC.
Markus Sebastian, senior vice president and managing director, EMEA, Align Technology, said: “We are pleased to be the first medical device company in the region to have obtained the Class IIa EC Certificate for our clear aligners and retainers under the new medical device regulations that recently came into effect. This classification places clear aligners in the same classification category in the EU as traditional bracket and wire braces, reinforcing that clear aligner orthodontic appliances are indeed medical devices. While this change will not impact how dental practitioners use our products to treat their patient’s malocclusions, the certification does confirm that Align’s treatment planning and manufacturing processes have been closely scrutinised in a rigorous review by independent experts. Our doctor customers and their patients can be confident that Align Technology products comply to the very highest standards of safety and clinical performance.”