According to a news release, the EC wants to assess a potential breach of European Union competition rules. It said this centers around the alleged tying of Align’s iTero intra-oral scanners to its dental clear aligners branded as Invisalign. The investigation follows a complaint by a competitor.
The EC says this marks its first formal antitrust investigation in the medical device sector as well.
Intra-oral scanners represent the digital entry point into the clear aligner market, according to the EC. It opened this investigation because it has concerns that Align may have “unfairly leveraged” its Invisalign offering by “effectively forcing dental professionals to purchase the iTero scanner if they wish to order Invisalign for their patients.”
The investigation focuses on the company’s interoperability strategy. In it, the EC alleges a refusal to approve competing scanners for the automated submission to Align of digital scans for Invisalign orders since 2017. Additionally, it alleges a refusal to accept dental professionals’ submissions of scans generated by other intra-oral scanners.
“This creates a closed ecosystem around Invisalign,” the EC alleges. “By limiting the possibility to order Invisalign clear aligners using competing intra-oral scanners, Align Technology may be shielding its iTero scanners from competition while protecting its possible dominance in the clear aligner market.”
Align Technology responds to European Commission investigation
In a press release issued by Align Technology, the company said it remains committed to conducting business “with integrity and in full compliance with global competition laws.”
The company said its iTero platform supports an open, diverse digital dental ecosystem. It said the scans can export to order aligners other than Invisalign. Align also said it maintains a scan acceptance policy designed to ensure clinical quality, patient safety and system reliability.
“The Commission’s step is purely procedural and allows it to gather information,” the company wrote. “It does not reflect a conclusion on the merits of the case, nor does it constitute an accusation or a finding of wrongdoing. The opening of an investigation does not prejudge its outcome.
“Align is confident that any review of Align’s scanner and scan acceptance policies will reflect the robust and dynamic nature of the teeth-straightening market and believes its practices comply with applicable competition laws. We will cooperate fully and engage constructively with the Commission through the appropriate channels.”
