MDD products under MDR certificate

[Ololo]

Hi all,

As a Distributor can company still sell to customers MDD products (expired MDD certificate but placed on the market prior Certificate expiration date) under new valid MDR certificate. Or first MDD stock needs to be depleting and only after Distributor can get MDR products. Thank you!!!

 

[Ed Panek]

If the devices are "on the market" today, you may sell them. Article 120 of the MDR has more detail.

 

[Ololo]

Article 120 of the MDR

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If the devices are "on the market" today, you may sell them. Article 120 of the MDR has more detail.

Yes there is a derogation period for MDD products. But what if there is no control on MDD and MDR products (both products are in the stock), and system cannot see what is MDD and what is MDR. Can MDD product be send to the customer under MDR certificate without any notification to customer.

 

[EmiliaBedelia]

Per the regulation, MDD products that were on the market prior to the MDD cert expiry date can be sold until 27 May 2025. This is the only requirement in the regulation. I do think it would be a smart idea to keep on hand the documentation that shows these products were lawfully approved under MDD and on the market prior to the expiry date just in case you get questioned later on.

Whether your customers would have a problem with receiving MDD product is a different question.
Is there any actual difference in the product? I imagine there may have been label updates to comply with MDR - will customers notice/care about the differences? If any information was changed (eg, authorized rep, NB, etc) will the customer be able to find the info they need? Does the labeling have all languages required for the region you are distributing in? Again I don't think this is a strict requirement of the regulation, just a "CYA" measure that you may want to think through. As a distributor these considerations may not even be an issue for you. Just something to think about....

Also note that if you distribute to any other distributors, they may have concerns about receiving MDD product, especially if it is crossing country lines.

 

[Ololo]

Per the regulation, MDD products that were on the market prior to the MDD cert expiry date can be sold until 27 May 2025. This is the only requirement in the regulation. I do think it would be a smart idea to keep on hand the documentation that shows these products were lawfully approved under MDD and on the market prior to the expiry date just in case you get questioned later on.

Whether your customers would have a problem with receiving MDD product is a different question.
Is there any actual difference in the product? I imagine there may have been label updates to comply with MDR - will customers notice/care about the differences? If any information was changed (eg, authorized rep, NB, etc) will the customer be able to find the info they need? Does the labeling have all languages required for the region you are distributing in? Again I don't think this is a strict requirement of the regulation, just a "CYA" measure that you may want to think through. As a distributor these considerations may not even be an issue for you. Just something to think about....

Also note that if you distribute to any other distributors, they may have concerns about receiving MDD product, especially if it is crossing country lines.

Huge thanks!
As a Distributor we still need to do EO verification. Labels will be updated to comply with MDR. So still some changes. I could not find anything in regulation that says we need to control what is going to the customer MDD (were on the market prior to the MDD cert expiry date) or MDR.
As both is complaint.
Just it a little bit strange that system will see it as MDR compliant but we will send mix of MDD and MDR.

 

[Ed Panek]

My company is likely to miss the MDR deadline of our MDD cert expiring. For mitigation, we are planning to warehouse the volume of our device in EU. There is also a path if a CA in EU thinks your device is needed in that country. An important customer will help make that argument to the CA of THAT COUNTRY ONLY.

 

[Ronen E]

For mitigation, we are planning to warehouse the volume of our device in EU.

You need to look into the details very carefully and build a solid case (documented in detail) why that would constitute Placing on the Market. Simply moving product onto EU soil won't necessarily suffice.

There is also a path if a CA in EU thinks your device is needed in that country. An important customer will help make that argument to the CA of THAT COUNTRY ONLY.

AFAIK this is reserved for public health emergencies (e.g. COVID) or cases where the CA deems that device to be of special/high importance for the healthcare of the State population. It's not really for "vanilla"-needed type of situations. Additionally, once one CA (in one Member State) clears it, it legally cascades to all other Member States (that's another reason they won't take it lightly).

 

[Nuno_]

Per the regulation, MDD products that were on the market prior to the MDD cert expiry date can be sold until 27 May 2025. This is the only requirement in the regulation. I do think it would be a smart idea to keep on hand the documentation that shows these products were lawfully approved under MDD and on the market prior to the expiry date just in case you get questioned later on.

Whether your customers would have a problem with receiving MDD product is a different question.
Is there any actual difference in the product? I imagine there may have been label updates to comply with MDR - will customers notice/care about the differences? If any information was changed (eg, authorized rep, NB, etc) will the customer be able to find the info they need? Does the labeling have all languages required for the region you are distributing in? Again I don't think this is a strict requirement of the regulation, just a "CYA" measure that you may want to think through. As a distributor these considerations may not even be an issue for you. Just something to think about....

Also note that if you distribute to any other distributors, they may have concerns about receiving MDD product, especially if it is crossing country lines.

This situation is more complex than it might appear. I work for an MD distributor, and I'm worried about what might happen in 2024/25. We have a huge number of devices whose certificates expire between January and May 2024. Many of these devices will not transition to MDR. Which means we have until May 2025 to sell all remaining stock, which probably won't happen and we'll be left with a lot of obsolete devices in stock. In May 2025 what will happen is that an unbelievable number of devices that are compliant (according to the MDD) and within their expiration date will have to be discarded and destroyed just because of the MDR. It will be extremely complicated to manage all the stock, manage recalls with the manufacturers, and eventually there will be stock outs of some types of devices whose manufacturers did not want to transition to the MDR.
Regarding the second part of your text, the end users of our devices (mostly surgeons and OR staff, we mainly work with class III implants) do not even know that there is an MDR, so they will never question it.
My big question is: 1) if the devices are compliant (by MDD); 2) if the devices are within their expiration date; Why the hell are we going to throw these devices in the trash, wasting millions of euros in resources? Everyone knows that the transition to MDR is extremely difficult for manufacturers and NB, and that not all MDs will transition in time. This doesn't make much sense to me.

 

[Junn1992]

My big question is: 1) if the devices are compliant (by MDD); 2) if the devices are within their expiration date; Why the hell are we going to throw these devices in the trash, wasting millions of euros in resources?

Because the CE mark is invalidated, therefore you cannot sell in EU anymore.

I would suggest some form of agreement between yourself and your customers to sell as much as you can and stock up as much as you can at the "customer" end of things.

Other than that, there really isn't a "way out", unless you get a CA decision that these devices are "essential"

 

[Nuno_]

Because the CE mark is invalidated, therefore you cannot sell in EU anymore.

I would suggest some form of agreement between yourself and your customers to sell as much as you can and stock up as much as you can at the "customer" end of things.

Other than that, there really isn't a "way out", unless you get a CA decision that these devices are "essential"

Thanks for the answer. I understand the invalid CE marking situation, even though I never agreed to it.
The problem is that our customers don't have stock, we basically work just in time, we have to run to the hospital every day with new devices.
The years 2024/2025 are going to be turbulent.