Article 22 - Include statement in procedure pack?

#1
Hi all,

Our company is currently developing a procedure pack for the first time. We have drafted the procedure pack statement as described in Article 22 of the MDR. However, I am having trouble figuring out if the statement is supposed to be in the procedure pack, or if it is for us to hold on to untill our CA comes and asks for it. I don't see any specific language in Article 22 about including it...

What is your point of view on this? Any help is appreciated!
 
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