Medical device technical files template: learn how to verify Annex II/III alignment, GSPR traceability, risk integration, and clinical support to avoid MDR review gaps.

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.

EU Sets AI Review Path for Rehab Device CE Marking: learn how the revised MDR guidance changes AI clinical evaluation, Notified Body validation, and EU market entry planning.

EU Tightens MDR Rules for AI Rehab Devices: learn how the new EU MDR Annex XVI amendment reshapes CE certification, clinical assessment, and market access for AI-enabled rehabilitation products.