Several CE Marks on a Repaired Class IIa Medical Device

[MDD_QNA]

We have a product (class IIa medical device) that we took over from another company in 2012. The other company had its own CE-mark on since 2002. And when we took it over we took over service of all of the products produced since 2002 that still had a service contract. The life time of the device or the service contract ranges up to 10 years.
So my question is, now when we do repairs on the product and exchange a part on the old md with the old ce-mark (another NB), can we put our own (new) ce-mark (our NB) on that part (if it is a part that has a label on it) on the product? There are 3 different labels on the product, do we have to exchange all the labels when we change a part with a label on it that is different from the other parts?

 

[pkost]

Re: Several CE-marks on a repared product

I'm not sure it is appropriate for you to change the manufacturer of the product....It was manufactured and released and placed on the market by the other company....you have not placed that particular machine on the market - you are just servicing it.

If the part that you are replacing has a CE mark in it's own right and is release/placed on the market by you, then this should have you as manufacturer

 

[MDD_QNA]

Re: Several CE-marks on a repared product

I'm not sure it is appropriate for you to change the manufacturer of the product....It was manufactured and released and placed on the market by the other company....you have not placed that particular machine on the market - you are just servicing it.

If the part that you are replacing has a CE mark in it's own right and is release/placed on the market by you, then this should have you as manufacturer

We took over everything. The manufacturing company is our CMO now and we are the legal manufacturer. The company that took it over first didn't have enough knowledge (it seems). And that is why they transferred it to us after they acquired us as well. And now we are left with a service contract for a product that we didn't develop or anything basically. But since the service contract is in place we have to serve it. If we cannot state why we shouldn't.

The part that we are replacing doesn't have our CE-mark. It has company A's CE-mark. We exchange the part, and put our CE-mark on it (Company B) since it is our part. And then the product has two more labels with another CE-mark. Which means 1 CE-marked label from company A and 2 CE-marked labels from company B. From what I know from a regulatory point of view it is not allowed to have different NBs for one product (which I assume means two different CE-marks/labels/company names on one product). But since it is a question of reparation or exchange and the parts have already been cleared how do we solve the reparation of the faulty part?

 

[shimonv]

I agree with Pkost. It's better to distinguish between new products that come with your name on it than legacy products which are merley serviced by you.
Less work from service operations and possibly less questions by third party auditors.

Thanks,
Shimon

 

[MDD_QNA]

Yes, I agree. But now that we are in this situation and we can't change the agreement anytime soon what can we do to make it easier? It is part of a company's goodwill to service the products for at least some customers, right?
So is there a solution around it? Or do we have to take the easy way out and say no?

 

[pkost]

Re: Several CE-marks on a repared product

We took over everything. The manufacturing company is our CMO now and we are the legal manufacturer. The company that took it over first didn't have enough knowledge (it seems). And that is why they transferred it to us after they acquired us as well. And now we are left with a service contract for a product that we didn't develop or anything basically. But since the service contract is in place we have to serve it. If we cannot state why we shouldn't.

A service contract is not covered by the device directive, it is out of scope - I would suggest speaking to your legal team regarding any issues with this

The part that we are replacing doesn't have our CE-mark. It has company A's CE-mark. We exchange the part, and put our CE-mark on it (Company B) since it is our part.

This doesn't make much sense...it may be your part, but who is the manufacturer? who "placed the product on the market"...This is who's CE mark it should be.

From what I know from a regulatory point of view it is not allowed to have different NBs for one product

but they are different products, so they can have different NBs

But since it is a question of reparation or exchange and the parts have already been cleared how do we solve the reparation of the faulty part?

the faulty part is fixed, it does not impact the "manufacturer" of the product.




For example..(I have modified this from reality to assist in understanding..hopefully it doesn't introduce more confusion)

Company A manufactures a CT machine, releases it to market and sells it to Hospital A. Company B is bought by Company A, also manufactures it's own CT machine and takes on servicing obligations of Company A

The CT machine in Hospital A is, and will always be CE marked by Company A, because it has been placed on the market and released.

Secnario 1:
CT machine develops a fault and Company B has to replace a capacitor (or some other small part)....This does not require a CE mark because a capacitor is not a medical device or accessory - it is a component....The regulatory status of the CT machine does not change - it is still CE marked by Company A

Scenario 2:
the mattress on the CT bed becomes so worn that it needs to be replaced...the mattress prevents pressure sores and is therefore a medical device...it is also non specific to the CT machine. In this case Company B replace the matteress with their own CE marked product; however the CT machine CE mark remains with Company A

Scenario 3:
As Scenario 2, but Company A produced large quantities of stock of the mattress; they were released to market....In this case the mattress; company B sell the mattress to the Hospital; the CT machine remains CE marked by Company A, the mattress is also CE marked by company A



The key thing to focus on is...is the item a device...if so, who released it to the market...they are the CE holder. If it is not a device, it should not have a CE (except as part of another directive/regulation, but that's a whole other level of complexity)

 

[somashekar]

Re: Several CE-marks on a repared product

Service the product as if the other company would have serviced it, and follow all the servicing requirements that the other company had laid out. You are not touching the main label or affixing any CE mark.

 

[MDD_QNA]

Re: Several CE-marks on a repared product

Thank you!

Secnario 1:
CT machine develops a fault and Company B has to replace a capacitor (or some other small part)....This does not require a CE mark because a capacitor is not a medical device or accessory - it is a component....The regulatory status of the CT machine does not change - it is still CE marked by Company A

But the capacitors has to be equal, right? You can't change it to one that has different specifications etc?

Scenario 2:
the mattress on the CT bed becomes so worn that it needs to be replaced...the mattress prevents pressure sores and is therefore a medical device...it is also non specific to the CT machine. In this case Company B replace the matteress with their own CE marked product; however the CT machine CE mark remains with Company A

Scenario 3:
As Scenario 2, but Company A produced large quantities of stock of the mattress; they were released to market....In this case the mattress; company B sell the mattress to the Hospital; the CT machine remains CE marked by Company A, the mattress is also CE marked by company A

What if in both case 2 and 3, the mattress has the CE mark of company A on it (like a label or a mark)? Can company B use it? Or do they have to scrap it?

The key thing to focus on is...is the item a device...if so, who released it to the market...they are the CE holder. If it is not a device, it should not have a CE (except as part of another directive/regulation, but that's a whole other level of complexity)

The whole product is a or the device. The one who is the CE holder doesn't exist anymore.

 

[MDD_QNA]

Re: Several CE-marks on a repared product

Service the product as if the other company would have serviced it, and follow all the servicing requirements that the other company had laid out. You are not touching the main label or affixing any CE mark.

There is a label or sticker on 3 important parts/components and these components often need repair/servicing so it is not doable. Let's not go into how that company has handled it so far...

 

[pkost]

Re: Several CE-marks on a repared product

Thank you!

Secnario 1:
CT machine develops a fault and Company B has to replace a capacitor (or some other small part)....This does not require a CE mark because a capacitor is not a medical device or accessory - it is a component....The regulatory status of the CT machine does not change - it is still CE marked by Company A

But the capacitors has to be equal, right? You can't change it to one that has different specifications etc?

Correct - you cannot change the specification, Company A should have provided a servicing manual, Company B should just follow that

Scenario 2:
the mattress on the CT bed becomes so worn that it needs to be replaced...the mattress prevents pressure sores and is therefore a medical device...it is also non specific to the CT machine. In this case Company B replace the matteress with their own CE marked product; however the CT machine CE mark remains with Company A

Scenario 3:
As Scenario 2, but Company A produced large quantities of stock of the mattress; they were released to market....In this case the mattress; company B sell the mattress to the Hospital; the CT machine remains CE marked by Company A, the mattress is also CE marked by company A

What if in both case 2 and 3, the mattress has the CE mark of company A on it (like a label or a mark)? Can company B use it? Or do they have to scrap it?

Did company A release the product, or was it part manufactured? if it was released by company A, it can retain the label. If it was part manufactured, Company B would have to jump through regulatory hoops to CE mark it themselves

The key thing to focus on is...is the item a device...if so, who released it to the market...they are the CE holder. If it is not a device, it should not have a CE (except as part of another directive/regulation, but that's a whole other level of complexity)
The whole product is a or the device. The one who is the CE holder doesn't exist anymore.

It is irrelevant if the company exists or does not exist...they released the product at that the time. There are lots of products on the market that continue to be sold after the manufacturer has gone into administration.