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Distributor and ISO 13485

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Guest user Created:   Jun 21, 2023 Last commented:   Jun 21, 2023

Distributor and ISO 13485

I am revising the Distributor's Agreement and wondering to what extent our quality control shall go to ensure the ISO 13485?
In other words, how much can I ask of the distributor in terms of complying with ISO 13485? 
Should the medical device distributor have ISO certification or only knowledge of it?

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ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

ISO 13485 DOCUMENTATION TOOLKIT

Step-by-step implementation for smaller companies.

Expert
Kristina Zvonar Brkić Jun 21, 2023

There is no MDR requirement that distributors of medical devices need to be certified according to ISO 13485. But, as stated in Article 14 - General Obligations of Distributors, the following elements must be in place: 

  • storage conditions as stated on the medical device and by the manufacturer
  • have in place a complaint system - how they can receive a complaint and how they will inform the manufacturer of the received complaint
  • must have in place a system for recall - distributor of course will never start a recall, but rather will be a part of the process - they must know how they must behave in a situation when they receive information from the manufacturer that they must withdraw the products from their market.
  • communication with a competent authority
  • have and maintain a shorter version of the medical device file - declaration of conformity, EC certificate, instruction of use, storage conditions, installation, and/or service manual (if applicable)

For more information, see:

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Jun 21, 2023

Jun 21, 2023