The German Accessibility Strengthening Act (BFSG), implementing the European Accessibility Act Directive (EU 2019/882), takes effect on June 28, 2025.
While medical devices themselves are not within the scope as a product category, accessibility requirements may still apply where medical device software operates on EAA-covered hardware (e.g., smartphones, tablets). E-commerce services, including webshops selling medical devices directly to patients, must also be EAA-compliant. Certain components of medical or healthcare apps, particularly account creation and registration functions, will likely need to meet EAA accessibility standards since they involve consumer contracts. It remains to be seen whether this applies only to subscription-based apps or also to free apps. For a more detailed insight please see our Insight Plus alert: Germany: Are medical devices affected by the German Accessibility Strengthening Act implementing the European Accessibility Act (Directive (EU) 2019/882)?
