Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

All,

I'm new to the shipment of medical devices to the EU and have a question pertaining to the Declaration of Conformity.

Do we need to automatically send a Declaration of Conformity with each shipment to a Member State, or just the first shipment to a customer? Or, do we simply need to have it available, in the respective Member State's local language, upon request?

Thank you!

Hello,

Often it depends on the type of device, conformity assessment route, and how the device is shipped.  Often when we were shipping from the US to EU we included the DofC in the first few shipments because we found the shipment would be held in customs/border control because they wanted to see the DofC.  Then after a while when the shipments were routine, we did not send them.  Other companies worked for/with we always sent one (1) DofC with the shipment.  In the future, this should be a moot point because DofC will be uploaded to EUDAMED so anyone including customs/border control can look up the information.  You should have a process for when this is requested the right information is sent and persons know what to send.  I was involved in one instance where customs was asking for the DofC for a shipment, customer service did not know what they wanted and it ended up sitting there for a couple weeks before it was returned to our office.  Our customer was not happy when they had to wait an additional week, almost 3 weeks later, to get the product.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 28-Oct-2019 10:16
From: Anonymous Member
Subject: Sending DoC with shipment?

This message was posted by a user wishing to remain anonymous

All,

I'm new to the shipment of medical devices to the EU and have a question pertaining to the Declaration of Conformity.

Do we need to automatically send a Declaration of Conformity with each shipment to a Member State, or just the first shipment to a customer? Or, do we simply need to have it available, in the respective Member State's local language, upon request?

Thank you!

Richard,

I assume that multiple DofCs will require upload to EUDAMED due to need translation requirement?

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Tonia Bryant
Director, Quality & Regulatory Affairs
Cary NC
United States
------------------------------

Original Message:
Sent: 29-Oct-2019 07:48
From: Richard Vincins
Subject: Sending DoC with shipment?

Hello,

Often it depends on the type of device, conformity assessment route, and how the device is shipped.  Often when we were shipping from the US to EU we included the DofC in the first few shipments because we found the shipment would be held in customs/border control because they wanted to see the DofC.  Then after a while when the shipments were routine, we did not send them.  Other companies worked for/with we always sent one (1) DofC with the shipment.  In the future, this should be a moot point because DofC will be uploaded to EUDAMED so anyone including customs/border control can look up the information.  You should have a process for when this is requested the right information is sent and persons know what to send.  I was involved in one instance where customs was asking for the DofC for a shipment, customer service did not know what they wanted and it ended up sitting there for a couple weeks before it was returned to our office.  Our customer was not happy when they had to wait an additional week, almost 3 weeks later, to get the product.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 28-Oct-2019 10:16
From: Anonymous Member
Subject: Sending DoC with shipment?

This message was posted by a user wishing to remain anonymous

All,

I'm new to the shipment of medical devices to the EU and have a question pertaining to the Declaration of Conformity.

Do we need to automatically send a Declaration of Conformity with each shipment to a Member State, or just the first shipment to a customer? Or, do we simply need to have it available, in the respective Member State's local language, upon request?

Thank you!

This message was posted by a user wishing to remain anonymous

Hi,
I think it depends on the format of your DoC. If you issue the DoC lot by lot then send it with each shipment not automatically but on request by customer, if you issue a DoC which is valid for two years send it once.
Original Message:
Sent: 28-Oct-2019 10:16
From: Anonymous Member
Subject: Sending DoC with shipment?

This message was posted by a user wishing to remain anonymous

All,

I'm new to the shipment of medical devices to the EU and have a question pertaining to the Declaration of Conformity.

Do we need to automatically send a Declaration of Conformity with each shipment to a Member State, or just the first shipment to a customer? Or, do we simply need to have it available, in the respective Member State's local language, upon request?

Thank you!

Tonia,

To be honest I am not sure about multiple DofCs and translation requirements as there is not really any clear information from the regulation or EUDAMED specifications.  I would think based on the "simple" information contained in the DofC maybe an English version might be acceptable.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 29-Oct-2019 02:57
From: Anonymous Member
Subject: Sending DoC with shipment?

This message was posted by a user wishing to remain anonymous

Hi,
I think it depends on the format of your DoC. If you issue the DoC lot by lot then send it with each shipment not automatically but on request by customer, if you issue a DoC which is valid for two years send it once.
Original Message:
Sent: 28-Oct-2019 10:16
From: Anonymous Member
Subject: Sending DoC with shipment?

This message was posted by a user wishing to remain anonymous

All,

I'm new to the shipment of medical devices to the EU and have a question pertaining to the Declaration of Conformity.

Do we need to automatically send a Declaration of Conformity with each shipment to a Member State, or just the first shipment to a customer? Or, do we simply need to have it available, in the respective Member State's local language, upon request?

Thank you!