Unfair competition: the EU launches its first-ever investigation into medical devices

Brussels – Concerns regarding abuse of a dominant position in the medical devices sector have prompted the European Commission to launch its first formal investigation into unfair competition in this sector, targeting Align Technology and its conduct within the single market. According to the European Commission, the US firm, which specialises in manufacturing intraoral scanners for dentists, is alleged to have forced customers to purchase its optical scanners. Following a formal complaint lodged with the European Commission, an investigation has been launched. 

Intraoral scanners are used to perform digital scans for orthodontic care and treatment, as well as for restorative treatments. Depending on their application, these are used to produce removable prostheses, such as clear aligners to correct dental misalignment, or fixed implants for reconstruction. Until 2017, Align Technology held a monopoly on clear aligners thanks to patents that granted it exclusivity over the products, which were sold under the Invisalign brand. The Commission considers that, from 2017 onwards, the US company has continued to operate as a monopolist through practices designed to discourage competition.

Specifically, the EU competition authority fears that Align Technology may have unduly exploited its position as the market leader in Invisalign clear aligners, effectively forcing dental professionals to purchase the intraoral scanner iTero, manufactured by Align Technology, in order to prescribe Invisalign to their patients. This obligation to purchase is said to have been enforced by refusing to accept scans generated by other intraoral scanners, even if based on industry-standard files, sent by dental professionals. 

“The investigation launched today by the Commission underlines our commitment to preserving fair markets that work for everyone, including in the healthcare sector,” emphasises the Executive Vice-President for a Clean, Fair and Competitive Transition, Teresa Ribera, who is determined to safeguard the oral health of all Europeans, given that “clear aligners have transformed orthodontics for millions of Europeans, offering a discreet and innovative solution for patients of all ages.” 

The launch of the investigation marks the first case of an alleged breach of competition rules in the medical devices sector, which has so far been subject to investigations focused solely on procurement and the way in which China and its operators were involved.