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Addition of a Class 1 (Sterile) Medical Device

J1980b

Starting to get Involved
#1
Hello,

Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.

The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)

I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.

Thanks in advance

J1980b
 
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GStough

Staff member
Super Moderator
#3
Hello,

Could someone please confirm if I would need to make a submission to my regulatory body to manufacture a Class ! (sterile) device.

The device does fall within one of our Annex V scope product descriptions. It is a new product within this generic grouping (ie different materials, and a few different components)

I am confused as to if I need to make a formal submission to them and at what level, as technically its not an addition to scope.

Thanks in advance

J1980b
There are stringent requirements that pertain to sterile medical devices not only here in the US, but in the EU, as well. I believe it would be wise to ask your regulatory body at least, because while it may not be an addition to scope, it would involve an additional process (sterilization) which would require validation and monitoring (especially if it is an outsourced process).

I could be wrong about this, but I think it would be wise to contact your regulatory body (or maybe registrar or notified body, etc.).

I hope this helps some, anyway... :bigwave:
 

chris1price

Trusted Information Resource
#4
Hi

Assuming there is no change in the manufacturing processes that would effect sterilisation or changes to the sterilisation process itself and the scope of your CE Certificate does not require modifying, your Notified Body should have little interest in this change.

However, I would still contact them in writing, saying what you are doing and explaining that there are no significant changes that effect them. That way there should be no surprises when it comes to your next scheduled audit.

Chris
 
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