The European Commission has formally launched its first antitrust investigation in the medical device industry against Align Technology, Inc.

Source: European Commission

DentalGoodNews｜On June 30, 2026, local time, the European Commission announced in Brussels that it has formally initiated an antitrust investigation into Align Technology (Align Technology, Inc., NASDAQ: ALGN), the parent company of Invisalign. The investigation focuses on potential bundling and interoperability restrictions between its iTero intraoral scanner and Invisalign clear aligner businesses within the European Economic Area (EEA). The Commission noted that this is the first formal antitrust investigation in the field of medical devices.

The European Commission’s core concern is that Align Technology may be leveraging its dominant position in the clear aligner market to tie the sale of its market-leading Invisalign clear aligners (the tying product) to the use of its certified intra-oral scanners. Among the scanners it has approved, only Align Technology’s iTero scanners are understood to remain at the most advanced technological level. The Commission considers that this conduct may have been ongoing since 2016, and that its effects are twofold: on the one hand, it restricts competition in the intra-oral scanner market, and on the other hand, it reinforces Align’s dominant position in the clear aligner market.

The Commission notes that intra-oral scanners are the digital entry point to the clear aligner market. Dental professionals use these scanners to generate three-dimensional digital models of patients’ dentition, which are used to order Invisalign clear aligners as well as to plan restorative treatments such as crowns and implants. Invisalign, developed by Align Technology, held a near-monopoly position in the clear aligner market prior to the expiry of its patent protection in 2017.

If the alleged conduct is confirmed, Align Technology may be in breach of Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the European Economic Area (EEA) Agreement, both of which prohibit the abuse of a dominant position that may restrict competition in the Single Market. The procedure was formally initiated under Article 11(6) of Regulation 1/2003 and Article 2(1) of Regulation 773/2004. Following the initiation of proceedings, national competition authorities of EU Member States are also relieved of their competence to apply EU competition law to the case. The case has been registered in the Commission’s public case register under Case No. AT.40900.

The Commission stated that the investigation will be treated as a priority, with no set deadline. The actual duration will depend on the complexity of the case, the level of cooperation from the company, and the exercise of defense rights by the parties involved.

Source: Align Technology Official Website

In response to the Commission's investigation, Align Technology issued a statement on the same day denying any unfair competition practices. The company stated that the iTero intraoral scanner platform is designed to support an open and diverse digital dental ecosystem. Scan files generated by iTero can be exported and used for ordering aligners other than Invisalign. The company also maintained that its scan acceptance policy is intended to ensure clinical quality, patient safety, and system stability, rather than to restrict competition.

Align Technology stated that the Commission's action is a "procedural step" solely for information gathering, representing neither a substantive determination of the case nor a charge or finding of violation. The company expressed confidence in its compliance status and stated it will fully cooperate with the Commission's investigation through appropriate channels.

This EU antitrust investigation is not the first time Align Technology has faced competition compliance scrutiny. According to previous reports by DGN, Align Technology reached a $31.75 million settlement with U.S. consumers in an antitrust class action related to SmileDirectClub (SDC), which received final approval from the U.S. District Court for the Northern District of California.