Class I - International Registrations

#1
We have Class I Med Devices.. actually accessories to be exact. In some cases, we have excess inventory and devices with the Direct Marking of the CE Symbol.. We are trying to understand if we can burn these off in International Markets which don't require the CE Mark or would we have to scrap the products.. Our thought process is.. (1) Products were manufactured prior to May 26, 2020. (2) They are not placed on the market and are sitting in the warehouse in the US.. Do we have to individually place these on every international Market, or can we continue to ship if we have approval from the authority in that market.. Some see this as an "offense" to the eU..

In other cases, we have Class I Products that will be MDR Compliant around May 15, 2020. Some countries require months of registration process. IF the MDD CE Mark goes NULL and Void on May 26, 2020.. There is a gap, i.e. WE are MDR Compliant and waiting for registration in that market but can't ship the Class I product because its not allowed, even though we have it in inventory..

What are you thoughts on this? How do we continue to ship into these markets using the CE Mark... or will we have to remove the labels, rework and scrap the product.
 
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#3
Are you a medical devices consultant (as your username suggests)?
We have Class I Med Devices.. actually accessories to be exact. In some cases, we have excess inventory and devices with the Direct Marking of the CE Symbol.. We are trying to understand if we can burn these off in International Markets which don't require the CE Mark or would we have to scrap the products.. Our thought process is.. (1) Products were manufactured prior to May 26, 2020. (2) They are not placed on the market and are sitting in the warehouse in the US.. Do we have to individually place these on every international Market, or can we continue to ship if we have approval from the authority in that market.. Some see this as an "offense" to the eU..

In other cases, we have Class I Products that will be MDR Compliant around May 15, 2020. Some countries require months of registration process. IF the MDD CE Mark goes NULL and Void on May 26, 2020.. There is a gap, i.e. WE are MDR Compliant and waiting for registration in that market but can't ship the Class I product because its not allowed, even though we have it in inventory..

What are you thoughts on this? How do we continue to ship into these markets using the CE Mark... or will we have to remove the labels, rework and scrap the product.
nkf
Are you a medical devices consultant (as your username suggests)?
not exaxtly..
 

Watchcat

Trusted Information Resource
#4
I think you have some fundamental misunderstandings about medical device regulation, the MDR, CE Marking, the role of the CE Mark in international registration, etc. Too many and too deep to get sorted out in an online forum. Should your company decide to secure the services of a medical device regulatory consultant with an understanding of these subjects, let us know. Three are a number of us who could help you, but I'm doubtful anyone will be willing to take on something like this free of charge.
 
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