Distributor and ISO 13485

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:

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