Chris P Created: Jul 14, 2022 Last commented: Jul 15, 2022

MDR compliance for distributors

Hello Could someone advise me as a distributor do I need my management system to be MDR compliant? I make sure all of my suppliers are MDR compliant, but I don't know if we also need to have that in our system. I did purchase the 13485 + MDR tool kit. I just read conflicting information on various sites. thanks

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Kristina Zvonar Brkić Jul 15, 2022

You as distributor need to be in a complaint with MDR in the domain of how long will you keep the documents from the medical devices (10 years for all devices, and 15 years for class IIb implantable and class III). In the Medical device file, you need to have an EC certificate, Declaration of conformity, Label, and instruction of use, and in case of devices that need installation and service, some installation and service manual.

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Jul 14, 2022

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