Distributor of Medical Devices - Is ISO certification required?

[dionysisf]

Hello,

We are a medical devices manufacturer (ISO 13485 certified) and we sell our CE marked devices in Europe via Distributors.

The question is if the distributor has to be ISO 9001 or 13485 certified?

It is noted that some of our distributors are responsible only for the distribution of the devices and others perform also the Preventive Maintenance Service of the devices (trained and authorized by the manufacturer).

Thanks in advance

 

[Sarah Stec]

The short answer is no, there is no EU regulatory requirement for a distributor to be ISO 9001 or 13485 certified.