2 July 2026

European Commission Opens First Formal Abuse of Dominance Investigation in Medical Devices Sector

2 min read

On 30 June 2026, the European Commission (the Commission) announced that it opened a formal investigation into medical device company Align Technology (Align) under Article 102 of the Treaty on the Functioning of the European Union (TFEU) and Article 54 of the European Economic Area Agreement, on suspicion that Align has engaged in abusive exclusionary conduct by tying access to its Invisalign® clear aligners, in the market for which it allegedly holds a dominant position, to the use of its iTero® intra-oral scanners, thereby shielding the latter from competition.

Align’s iTero^® scanners are used by dental professionals to generate a 3D digital scan of a patient’s teeth and jaws. The Invisalign^® aligners, in turn, are customised removable dental aligners made of clear plastic designed to treat teeth misalignment. The Commission’s press release (see, attached copy) notes that “[u]ntil 2017, Invisalign held a near monopoly in clear aligners due to patent protection”.

The Commission will investigate whether Align abused a dominant market position for Invisalign^® aligners by applying a “restrictive interoperability strategy” that “creates a closed ecosystem around Invisalign”. Under this strategy, Align allegedly refused to (i) approve competing state-of-the-art scanners for the automated submission to Align of digital scans for Invisalign^® orders since 2017; and (ii) accept digital scans submitted by dental practitioners that were generated by competing scanners, despite those scans being based on industry-standard files.

The Commission’s press release notes that the investigation follows a complaint by an – unidentified – competitor and “is the first formal antitrust investigation in the medical devices sector”.

In a public statement, Align expressed confidence that “any review of [its] scanner and scan acceptance policies will reflect the robust and dynamic nature of the teeth-straightening market“. It further described its iTero intraoral scanning platform as “designed to support an open and diverse digital dental ecosystem“, and stated that it “maintains a scan acceptance policy designed to ensure clinical quality, patient safety, and system reliability, including validation requirements for digital file submissions and the operational resources needed to support consistent processing across workflows“. These statements may foreshadow the justifications which Align will put forward in its defence before the Commission.

The Commission’s investigation follows a similar investigation by the Turkish Competition Authority and private actions in the US which were all dismissed.