ISO 13485:2016 regulatory expectations around distributors

ISO 13485:2016 is applicable to the distributors as well, according to section 1 of the standard. So it is expected that distributors will have implemented the ISO 13485:2016. Their quality management system will cover their distribution scope: how they receive medical devices, which documents they must check when receiving it from the manufacturer, how to store it, how to deliver it to the customer/client. Distributors must have in place a customer complaint process, have a proper place where returned products will be placed, and must have in place the process of communicating with the competent authority when needed.

Distributors must have in place QA agreements with manufacturers where mutual responsibilities will be stated.

For more information on the distributor's obligations, please see:

• EU MDR 2017/745 Article 14 - General obligations of distributor https://advisera.com/13485academy/mdr/general-obligations-of-distributors/