European Commission opens first formal antitrust investigation in the medical devices sector

Focus of the investigation

Align Technology is a U.S.-based medical device company, best known for two leading products: Invisalign clear aligners, used to correct teeth misalignment, and iTero intra-oral scanners, which enable dental professionals to create 3D digital scans of patients’ teeth and jaws. 

According to the EC, Invisalign enjoyed a near-monopoly position in clear aligners until 2017, due to patent protection. The EC also describes intra-oral scanners as the “digital entry-point” into the clear aligner market, as dental professionals rely on the digital scans for orthodontic treatments, including to order aligners. 

The investigation centers on whether Align Technology may have pursued a restrictive interoperability strategy, limiting dental professionals’ ability to order Invisalign clear aligners using competing intra-oral scanners and effectively forcing them to purchase iTero scanners to have access to Invisalign for their patients. 

In particular, the EC will examine whether Align Technology: (i) refused to approve competing scanners for the automated submission of digital scans used to order Invisalign aligners (since 2017); and (ii) refused to accept scans generated by rival scanners, despite those scans being based on industry-standard file formats. 

According to the EC’s preliminary concerns, these practices may have created a “closed ecosystem” around Invisalign, shielding iTero scanners from competition while also protecting Align Technology’s position in the clear aligner market.

What’s next? 

While the opening of formal proceedings does not prejudge the outcome of the case and there is no legal deadline for the EC to conclude the investigation, the EC has indicated that it will conduct its in-depth review “with priority”. 

Commenting on the investigation, Executive Vice-President Teresa Ribera stated that the case demonstrates the EC’s commitment to preserving “fair markets that work for everyone, including in healthcare.”

Why is this case relevant? 

• The investigation marks the EC’s first formal antitrust investigation in the medical devices sector. This contrasts with the U.S., where the industry has historically attracted more intensive antitrust scrutiny.  
• The case transposes concepts traditionally associated with digital-markets enforcement, such as ecosystem foreclosure and technical gatekeeping, into a medical devices context and signals that interoperability concerns are increasingly important across industries. Companies should, therefore, carefully assess whether their product design or compatibility requirements comply with EU competition law. 
• The investigation confirms that tying concerns can arise through technical design and approval choices alone, even in the absence of contractual obligations requiring customers to use a particular product or service. 
• The proceedings demonstrate the continued importance of competitor complaints as a catalyst for EC enforcement action.   
• The case also serves as a reminder that conduct by former patent holders aimed at preserving market power after patent expiry may attract antitrust scrutiny.

For more insights on antitrust enforcement in the life sciences industry, read our Global antitrust enforcement report and our Global trends in merger control enforcement report.