AngelRose
QA is a thankless job
I need assistance interpreting these extension periods.
Our company has a Class IIa device certified through EC verification (Annex IV MDD), with the CE Certificate issued by our Notified Body before 26/05/2021. The certificate doesn’t have an expiration date, so we assumed the CE mark would remain valid until the device’s expiration. Most of this batch was placed on the market before 26/05/2024, therefore, we didn’t plan to incur the costs of transitioning to MDR (hence, no confirmation letter). However, some health facilities are now rejecting our certificate, even though the devices were lawfully placed on the market (sold to the distributor) before 26/05/2024.
As a last resort, I’m considering invoking Article 120(4) of Regulation (EU) 2023/607 and referring to the European Commission's "Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 [...]" under Part E, regarding the deletion of the sell-off date.
I’ve contacted our NB for support, but they’ve been unresponsive. Do you guys think we were mistaken in not recalling our devices after 26/05/2024?
Our company has a Class IIa device certified through EC verification (Annex IV MDD), with the CE Certificate issued by our Notified Body before 26/05/2021. The certificate doesn’t have an expiration date, so we assumed the CE mark would remain valid until the device’s expiration. Most of this batch was placed on the market before 26/05/2024, therefore, we didn’t plan to incur the costs of transitioning to MDR (hence, no confirmation letter). However, some health facilities are now rejecting our certificate, even though the devices were lawfully placed on the market (sold to the distributor) before 26/05/2024.
As a last resort, I’m considering invoking Article 120(4) of Regulation (EU) 2023/607 and referring to the European Commission's "Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 [...]" under Part E, regarding the deletion of the sell-off date.
I’ve contacted our NB for support, but they’ve been unresponsive. Do you guys think we were mistaken in not recalling our devices after 26/05/2024?