Zero-distance XR Applications and Services: What the European Commission's XR Landscape Report Means for Health XR Developers
September 15, 2026
Focus area
EU, UK and international markets
Regulatory support beyond the US: EU MDR and IVDR, the EU AI Act, UK MHRA, Health Canada and other markets, aligned with IMDRF frameworks.
How we help
MDR technical documentation
Technical files, clinical evaluation plans and reports, and responses to notified body questions.
EU AI Act
How AI Act obligations apply to AI-enabled devices and how to fold them into your QMS.
UK and Canada
MHRA registration, UKCA marking, Health Canada licensing and reliance routes.
Global strategy
One evidence plan across FDA, notified bodies and other regulators, built on IMDRF frameworks.
