The European Commission (“Commission”) has opened its first formal investigation in the medical devices sector to assess whether Align Technology has breached EU competition rules by tying its intra-oral scanners to its dental clear aligners under the Invisalign brand.
Align Technology specialises in two product lines, namely clear dental aligners used in teeth misalignment treatment and intra-oral scanners branded as iTero used to generate 3D scans of patients’ teeth and jaws for the production of clear aligners. Intra-oral scanners play a key role in the clear aligner market as they are the starting point of the treatment process.
The Commission is concerned that Align Technology may be unfairly leveraging its position in the clear aligner market by requiring dental professionals to purchase the iTero scanner if they wish to order Invisalign for their patients.
The investigation focuses on two key exclusionary practices. First, the alleged refusal to approve competing state-of-the-art scanners for the automated submission of digital scans for Invisalign orders since 2017. Second, the alleged refusal to accept digital scans generated by other technically capable intra-oral scanners and submitted by dental professionals.
If the allegations are substantiated, these practices may create a closed ecosystem around Invisalign by limiting the ability of dental professionals to order Invisalign using competing scanners. The Commission considers that Align Technology may be shielding its scanners from competition while maintaining and strengthening its dominant position in the clear aligner market.
(Commission - 30.06.2026)
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