ISO 13485 and finished medical device from a supplier
Dear, i have this question. A company is manufacturing and marketing a class II medical device in Europe. This manufacturer outsource the medical device (liquid eye drops) from another company. The supplier supplies the substance "finished" and the manufacturer only makes the asepthic filling and packing. Because the supplier is producing the final product (except the packing) in bulk should they be ISO13485 certified ?
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ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more 
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
ISO 13485 DOCUMENTATION TOOLKIT
Step-by-step implementation for smaller companies.
Find out more
The supplier does not need to be ISO 13485 certified. However, that supplier is considered as a critical supplier for the manufacturer. According to the clause 4.1.5 of ISO 13485:2016, it is the manufacturer's responsibility to ensure conformity to ISO 13485:2016 and other applicable regulatory requirements at the supplier. There must be a quality agreement between manufacturer and supplier.
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Apr 20, 2020