Germany: Are medical devices affected by the German Accessibility Strengthening Act implementing the European Accessibility Act (Directive (EU) 2019/882)?

In brief

The German Accessibility Strengthening Act (BFSG), implementing the European Accessibility Act (Directive (EU) 2019/882), takes effect on 28 June 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, etc). E-commerce services, including web shops 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, as they involve consumer contracts. It remains to be seen whether this only applies to subscription-based apps or also to free apps.


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Contact Information
Frank Pflueger
Partner at BakerMcKenzie
Frankfurt
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frank.pflueger@bakermckenzie.com

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