The European Commission has officially launched a formal antitrust investigation to determine if US-based medical device manufacturer Align Technology has violated EU competition rules. Prompted by a competitor’s complaint, the probe marks the Commission’s first-ever formal antitrust investigation in the medical devices sector.
The investigation centers on whether Align Technology has abused its dominant market position by unfairly tying its flagship intra-oral scanners, branded as iTero, to its market-leading Invisalign clear aligners within the European Economic Area (EEA). Intra-oral scanners serve as the crucial digital gateway for orthodontic treatments, allowing dental professionals to take 3D digital scans to order clear aligners. Because Invisalign held a near-monopoly in the clear aligner market due to patent protection until 2017, the Commission is concerned that Align Technology is leveraging this dominance to shield its iTero scanners from fair competition.
Specifically, the European Commission is examining an alleged restrictive interoperability strategy consisting of two key measures. First, the company has reportedly refused approval for competing state-of-the-art scanners to handle automated digital scan submissions for Invisalign orders since 2017. Second, Align has allegedly refused to accept scan submissions from other intra-oral scanners, even when those scans are built on standard, industry-recognized files.
By systematically forcing dental professionals into a closed ecosystem where they must use an iTero scanner to prescribe Invisalign, Align Technology may be breaching Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the EEA Agreement, which strictly prohibit the abuse of a dominant market position.
The Commission will handle this in-depth investigation as a matter of priority, though the formal opening of these proceedings does not prejudge its final outcome. Under Regulation 1/2003, the initiation of this case relieves national competition authorities of their competence to apply EU competition rules to these specific practices. There is no legal deadline to conclude the investigation, as its duration will depend heavily on the case’s complexity and the extent of the company’s cooperation.
