I am updating a procedure detailing making arrangements for return of product (from distributors/hospitals (may involve product under clinical evaluation pre CE marking) and wondered if anyone could advise where requirements/guidance re: Product return (not necessariliy recall) are raised in ISO 13485.

Thanks

If you look at the guidance document ISO 14969:2004 it refers to these products in 8.3.4 "Any product returned to the organization should be treated as nonconforming product. For any returned product for which there is a risk of contamination (e.g. microbiological, viral, chemical,
radioactive), consideration should be given to regulatory requirements for hazardous materials." So it is dealt with in ISO 13485 paragraph 8.3.

ISO 14969 is a pretty good guidance.
Hope this helps

Rob.

Rob
Many thanks.