Medical Devices Group

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November 2018
Saurabh Dubey
Regulatory Affairs & Quality System
EU MDR Article 22

Can you explain what Article 22: System and procedure packs of EU MDR means?

What, exactly, do we do to comply with this article?

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Posted by Saurabh Dubey
Asked on November 12, 2018 4:13 pm
55 views
Private answer
Michelle Lott , RAC

Hi Saurabh,
This article applies to devices that are already CE marked in their own right and then combined by another party into what is essentially a kit. This article outlines requirements associated with the requirements for appropriately applying the CE mark to these “packs.” Does your company prepare such “packs” for further distribution? If so, we can discuss the requirements further. If no, this article does not apply to you.

Michelle

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