WHO Global Model Regulatory Framework for Medical Devices including In Vitro Diagnostic Medical Devices 8.3-refurbishing: Refurbishers meet the same requirements as original manufacturers (QMS certificate, technical documentation, declaration of conformity) and identify refurbished devices as such on labelling and commercial documents

What does 8.3-refurbishing require?

Refurbishing restores a durable device to a safety and performance condition comparable with new, including reconditioning, hardware or software updates leaving the intended use unchanged and replacement of worn or limited-life parts. The refurbishing party and the refurbished device must meet the same requirements as the original device, including a QMS certificate, technical documentation and a declaration of conformity, and a refurbished device should be marked as refurbished on its labelling and commercial documents. Routine maintenance, repair and part replacement are not refurbishment, but installing parts that significantly change intended purpose, characteristics or performance counts as a device change. Original manufacturers may be expected to provide information supporting maintenance, service, repair and decommissioning.