Interpretation of Regulation EU 2023/607

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?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I believe MDR has a provision where a manufacturer can petition the competent authority in the country in question to allow the devices to still be used. Others will know more. I think you require a healthcare organization to make the petition though.
 

Ronen E

Problem Solver
Moderator
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?
By the sound of it, you did nothing wrong (mind you, I'm not a legal practitioner). You legally placed those devices on the market, apparently.

Regardless, the healthcare facilities might refuse purchasing for whatever excessive reasoning they come up with. This is borderline commercial, not purely regulatory.

Now, strictly speaking - if you already sold the devices to a distributor, commercially it's their problem (not yours) if their customers refuse to purchase, and it would be their burden to convince the potential buyers that the devices are legit. I do understand that you still have stake in it and that you are highly interested in these units finding their way to the end users; just saying.

Maybe the way forward it a formal opinion issued by a lawyer specialising in the field.
 

zkinney

Registered
No lawyer, but Ronen E hit the nail on the head. As long as they were on EU soil by 26/05/2024 they are okay to be sold. This isnt a regulatory issue. Its commercial. You cant force the healthcare institutions to purchase your product. But perhaps you can clarify/educate them. You can try and get something in writing from the notified body to back it up, but they may or may not help as their duties also expired on 26/05/2024 unless you have some other relation with them.
 

AngelRose

QA is a thankless job
Thank you all for your valuable input! Our notified body has confirmed that the devices are indeed compliant, valid, and can still be put into service. They have been cautious in communicating this, likely to avoid providing any form of consultancy.

[...] This isnt a regulatory issue. Its commercial. You cant force the healthcare institutions to purchase your product. [...]
The issue persists, but as you mentioned, it falls outside the scope of QA. Therefore, I have redirected it to the relevant personnel.

Again, I want to sincerely thank everyone for taking the time to share their professional opinions and insights.
 
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