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November 2018
Saurabh Dubey
Regulatory Affairs & Quality System
EU MDR Article 22
1 min
reading time

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
275 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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Private answer
Kristin Gatter

Hi Michelle,

My company manufacturers a class IIA device that requires an insertion pack (class IIb) that is provided as a sterilized kit. The kit that we provide includes a sheath that is manufactured by a third party, has been verified and validated to work with our device, and bears its own CE mark. Are we required to provide a statement regarding the sheath to be compliant with Art. 22? If yes, how much information is required to be provided in that statement?

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