The European Commission has opened an antitrust investigation into Align Technology’s conduct linking its iTero intra‑oral scanners with its Invisalign clear‑aligner products. The probe follows a competitor complaint and marks the first formal antitrust case in the medical devices sector. Authorities are examining whether Align has abused a dominant position by tying the scanners to the aligners, effectively requiring dentists to purchase iTero to order Invisalign. The investigation focuses on two practices: rejecting approval of competing scanners for automatic submission of scans for Invisalign orders since 2017, and refusing to accept scans from other scanners even when they use standard file formats. If found to breach EU rules, the practices could violate Article 102 of the TFEU and Article 54 of the EEA Agreement. The case, AT.40900, will proceed as a priority investigation, and its outcome is not yet determined.
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