EU MDR Annex XVI now applies to rehab devices, moving electric wheelchairs and smart walking aids into Class IIa/IIb. See key CE, clinical evaluation, and PMPF impacts.

EFTA sets a new rehab device pre-clearance rule from July 15, requiring 72-hour PCN filing. Learn how CE documents, contracts, and timing may affect EFTA market shipments.

Red Sea disruption extends rehab device shipping times, pushing transit to 42–48 days and bookings at Shanghai and Ningbo to 14 days. See how distributors can protect Q3 supply plans.

EU MDR Annex XVI tightens AI rehab device filings from July 9, 2026. Learn new CE rules, ISO/IEC 17025 validation demands, and how to avoid delays in EU market access.