EU Opens Antitrust Investigation Into Align Technology Over Invisalign Sales Practices

According to The Wall Street Journal, in a report by Adrià Calatayud, European regulators are examining whether Align’s commercial practices may have breached European Union competition rules by linking sales of its Invisalign aligners with purchases of its iTero scanners. The investigation follows a complaint from a competitor and represents the European Commission’s first formal antitrust probe involving the medical-device sector.

The European Commission said it is assessing whether Align may have leveraged the strong market position of Invisalign to encourage or require dental professionals to purchase the company’s iTero digital scanners, a practice known in competition law as “tying.” Regulators are investigating whether such conduct could have limited competition within the European Economic Area by making it more difficult for rival manufacturers of dental scanners or orthodontic products to compete.

Under EU competition law, companies that hold a dominant market position are prohibited from abusing that position in ways that restrict competition or reduce consumer choice. While opening a formal investigation does not establish wrongdoing, it allows the Commission to conduct an in-depth examination of the company’s business practices before determining whether EU antitrust rules have been violated.

Read more: EU Opens In-Depth Antitrust Investigation Into Align Technology’s Invisalign Sales Practices

According to The Wall Street Journal, Align Technology did not immediately respond to a request for comment following the announcement of the investigation.

The case adds to a broader pattern of heightened European scrutiny of competition across industries, with regulators increasingly examining whether companies with significant market positions are using bundled products, exclusive arrangements, or other commercial practices to strengthen their dominance. In competition policy, tying arrangements can raise concerns if customers are pressured to purchase one product as a condition for obtaining another, potentially disadvantaging competing suppliers.

Align Technology is best known for its Invisalign clear aligner system, which is widely used by orthodontists and dentists as an alternative to traditional braces. The company’s iTero scanners are digital imaging devices that create three-dimensional scans of patients’ teeth and are commonly used during treatment planning.

The European Commission’s investigation will now proceed through its formal review process. The Commission has not set a deadline for completing the inquiry, and the opening of proceedings does not prejudge the outcome.

Source: The Wall Street Journal