Hi Ning,
the article 22 statement is a separate document. The system/procedure pack does not have a Declaration of Conformity in itself (except in the Article 22(4) case), because it is not considered a device. Each component of the system/procedure pack that is a device then has its own Declaration of conformity.
Best regards, Christoph
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Christoph Kiesselbach
Schrack & Partner
Reutlingen
Germany
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Original Message:
Sent: 06-Mar-2024 11:16
From: Ning Wang
Subject: System/Procedure pack
Hi All,
It is required by EU MDR article 22 that a statement should be drawn for the system/procedure pack. Should this statement be included in or separated from the Declaration of Conformity?
Thanks!
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Ning
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