R
RAMedOrtho
Evening all,
First time posting so apologies if I have done anything incorrectly!
My company has recently transferred to a new Notified Body due to previous NB suspending the CE marking aspect of their business. When we transitioned the new Notified Body (UK) assured us we could then swiftly transition to their EU NB, we were given an expected date of 29 March 2020 for completed EU transfer, only a few weeks after the UK NB certs were issued to us. They have now told us that our transition to the EU NB will not be until 24 April 2020.
This is causing us some worry as we had hoped to only update labelling once (straight to EU NB based on their assurance that it was extremely quick process to move from UK to EU). We received our UK NB certificates end Feb (ISO 13485:2016, Annex V) and beginning of March (Annex II). Due to stocking we determined our labels needed to be updated by June/Jul at the latest to ensure minimal stock write off at the end of the 6 month period. As they have delayed us this shortens our labelling implementation window by just over a month. The alternative is we manage a labelling update to their UK number and then again to the EU number, however, we have approx 220 pieces of artwork which will need updating. This could also impact on our stock as we will need to make sure nothing is placed on the market past the deadline(s). We are also concerned the EU NB transfer could be delayed again leaving us in a very precarious situation.
Has anyone else experienced this? The UK NB have told us that we can ask for an extension to the usual 6 month update timeline but we need to provide a rationale which their global team would then have to review and approve. Does anyone have any advice for doing this? We understand that this is a difficult time for everyone and are trying not to react hastily, any help would be greatly appreciated.
Thank you.
First time posting so apologies if I have done anything incorrectly!
My company has recently transferred to a new Notified Body due to previous NB suspending the CE marking aspect of their business. When we transitioned the new Notified Body (UK) assured us we could then swiftly transition to their EU NB, we were given an expected date of 29 March 2020 for completed EU transfer, only a few weeks after the UK NB certs were issued to us. They have now told us that our transition to the EU NB will not be until 24 April 2020.
This is causing us some worry as we had hoped to only update labelling once (straight to EU NB based on their assurance that it was extremely quick process to move from UK to EU). We received our UK NB certificates end Feb (ISO 13485:2016, Annex V) and beginning of March (Annex II). Due to stocking we determined our labels needed to be updated by June/Jul at the latest to ensure minimal stock write off at the end of the 6 month period. As they have delayed us this shortens our labelling implementation window by just over a month. The alternative is we manage a labelling update to their UK number and then again to the EU number, however, we have approx 220 pieces of artwork which will need updating. This could also impact on our stock as we will need to make sure nothing is placed on the market past the deadline(s). We are also concerned the EU NB transfer could be delayed again leaving us in a very precarious situation.
Has anyone else experienced this? The UK NB have told us that we can ask for an extension to the usual 6 month update timeline but we need to provide a rationale which their global team would then have to review and approve. Does anyone have any advice for doing this? We understand that this is a difficult time for everyone and are trying not to react hastily, any help would be greatly appreciated.
Thank you.
