Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

We have a device registered in multiple countries, e.g,, Australia, Argentina, Thailand, Chile, etc., based on MDD CE-marking that is planned for End of Life (essentially will not be made in compliance with MDR) and have the following questions:

1. Do we need to renew licenses in such countries where they expire?
2. Will consumables imported to support installed base be permitted in once the license has expired?
3. Is there any impact on AE's, i.e., either reporting in said country with expired license and/or reporting globally an event that occurred there with expired license?

We've established we can continue to support and ship consumables to the EU after the MDD certificate expires.

TIA

Hello Tia,

You would need to check each country requirements, because some the CE Certificate is just used to expediate the process and others the certificate is being used as a "home country approval" for the registration process.  To answer your three questions, there are different situations depending on the country.  However, by default #3 the expectation is reporting Adverse Events if the product is still being used in that country.  My recommendation is to have a clearly defined End of Life procedure describing the process, how you get to end of life, how you support after stop selling a product, etc.  But most importantly, having a End of Life Plan for each device or device family clearly describing how the product is taken off each market, if continued to be sold in other markets, consumables continuing to be provided, and when the actual "usable life" of a product would be reached for customers.  Depending on the product type, if a company decides to stop marketing/selling a device, these devices may need to be supported for many more years.  This should all clearly be described in the End of Life Plan.​

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 02-May-2021 11:06
From: Anonymous Member
Subject: CE-Marked Device for Other Countries - EoL

This message was posted by a user wishing to remain anonymous

We have a device registered in multiple countries, e.g,, Australia, Argentina, Thailand, Chile, etc., based on MDD CE-marking that is planned for End of Life (essentially will not be made in compliance with MDR) and have the following questions:

1. Do we need to renew licenses in such countries where they expire?
2. Will consumables imported to support installed base be permitted in once the license has expired?
3. Is there any impact on AE's, i.e., either reporting in said country with expired license and/or reporting globally an event that occurred there with expired license?

We've established we can continue to support and ship consumables to the EU after the MDD certificate expires.

TIA

In Russia, Kazakhstan, Belarus, Uzbekistan there would be no such requirements. In those countries you should be worrying only about local licences's expiration dates. Ukraine is different - they are aligned with EU guidelines.

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Oksana Kolosova
F. Hoffman-LaRoche
Moscow
------------------------------

Original Message:
Sent: 02-May-2021 11:06
From: Anonymous Member
Subject: CE-Marked Device for Other Countries - EoL

This message was posted by a user wishing to remain anonymous

We have a device registered in multiple countries, e.g,, Australia, Argentina, Thailand, Chile, etc., based on MDD CE-marking that is planned for End of Life (essentially will not be made in compliance with MDR) and have the following questions:

1. Do we need to renew licenses in such countries where they expire?
2. Will consumables imported to support installed base be permitted in once the license has expired?
3. Is there any impact on AE's, i.e., either reporting in said country with expired license and/or reporting globally an event that occurred there with expired license?

We've established we can continue to support and ship consumables to the EU after the MDD certificate expires.

TIA

Hi Tia,

I agree with both @Richard Vincins and @Oksana Kolosova. It varies from country to country. And I think for now you should focus on countries in which CE Certificate expiration will impact their license expiry date such as Ukraine, South Africa, Saudi Arabia, etc.​​

------------------------------
Fajar Dumadi
Regulatory Intelligence Officer
The Arazy Group
Vancouver BC
Canada
------------------------------

Original Message:
Sent: 02-May-2021 11:06
From: Anonymous Member
Subject: CE-Marked Device for Other Countries - EoL

This message was posted by a user wishing to remain anonymous

We have a device registered in multiple countries, e.g,, Australia, Argentina, Thailand, Chile, etc., based on MDD CE-marking that is planned for End of Life (essentially will not be made in compliance with MDR) and have the following questions:

1. Do we need to renew licenses in such countries where they expire?
2. Will consumables imported to support installed base be permitted in once the license has expired?
3. Is there any impact on AE's, i.e., either reporting in said country with expired license and/or reporting globally an event that occurred there with expired license?

We've established we can continue to support and ship consumables to the EU after the MDD certificate expires.

TIA