Regulatory Open Forum

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

Thanks for your answer Julie. The main problem is that the company who lost the CE mark is not my company and I can not contact the notified body of Company A to ask what Company A needed to do. I am just trying to understand in general terms what happens when a company loses their CE mark and what are their responsibilities with the products that are already distributed in the market.  I tried to make a google search but for some reason it is not very easy to find a clear answer.

Is there any guidance or document which explains  this?

Thanks in advance.
Regards,

Carmen

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

Thanks for your answer Julie. The main problem is that the company who lost the CE mark is not my company and I can not contact the notified body of Company A to ask what Company A needed to do. I am just trying to understand in general terms what happens when a company loses their CE mark and what are their responsibilities with the products that are already distributed in the market.  I tried to make a google search but for some reason it is not very easy to find a clear answer.

Is there any guidance or document which explains  this?

Thanks in advance.
Regards,

Carmen

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

"I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?"
According to art. 4 of the MDD, it is likely that your company may market the devices which had been legally CE market by company A.

"Do they need to recall all the products and inform the clients?"
They don't need to recall the legally CE marked products because they have lost their ability to CE mark the same type of products from now onwards.

"Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?"
They can use it, provided that such generator is legally CE marked. I mean, if company A had manufactured the generator before loosing the CE mark, but labelled, packaged and distributed it for sale  after loosing the CE mark, then the generators would not be legally CE marked and therefore should not be sold nor used.

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?
The ability and permission to carry out service maintenance activities on machines already on the market and in operation is not tied to being the legal manufacturer of the machine itself. There are independent conditions, requirements, authorizations etc. to allow carrying out service maintenance. 

Thanks for your answer Julie. The main problem is that the company who lost the CE mark is not my company and I can not contact the notified body of Company A to ask what Company A needed to do. I am just trying to understand in general terms what happens when a company loses their CE mark and what are their responsibilities with the products that are already distributed in the market.  I tried to make a google search but for some reason it is not very easy to find a clear answer.

Is there any guidance or document which explains  this?

Thanks in advance.
Regards,

Carmen

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

"I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?"
According to art. 4 of the MDD, it is likely that your company may market the devices which had been legally CE market by company A.

"Do they need to recall all the products and inform the clients?"
They don't need to recall the legally CE marked products because they have lost their ability to CE mark the same type of products from now onwards.

"Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?"
They can use it, provided that such generator is legally CE marked. I mean, if company A had manufactured the generator before loosing the CE mark, but labelled, packaged and distributed it for sale  after loosing the CE mark, then the generators would not be legally CE marked and therefore should not be sold nor used.

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?
The ability and permission to carry out service maintenance activities on machines already on the market and in operation is not tied to being the legal manufacturer of the machine itself. There are independent conditions, requirements, authorizations etc. to allow carrying out service maintenance. 

Thanks for your answer Julie. The main problem is that the company who lost the CE mark is not my company and I can not contact the notified body of Company A to ask what Company A needed to do. I am just trying to understand in general terms what happens when a company loses their CE mark and what are their responsibilities with the products that are already distributed in the market.  I tried to make a google search but for some reason it is not very easy to find a clear answer.

Is there any guidance or document which explains  this?

Thanks in advance.
Regards,

Carmen

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,

Thanks a lot to everyone for your answers. It is clear now what  is the path to follow. It was really difficult to get this information before, so I value a lot your explanations.

Thanks!

"I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?"
According to art. 4 of the MDD, it is likely that your company may market the devices which had been legally CE market by company A.

"Do they need to recall all the products and inform the clients?"
They don't need to recall the legally CE marked products because they have lost their ability to CE mark the same type of products from now onwards.

"Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?"
They can use it, provided that such generator is legally CE marked. I mean, if company A had manufactured the generator before loosing the CE mark, but labelled, packaged and distributed it for sale  after loosing the CE mark, then the generators would not be legally CE marked and therefore should not be sold nor used.

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?
The ability and permission to carry out service maintenance activities on machines already on the market and in operation is not tied to being the legal manufacturer of the machine itself. There are independent conditions, requirements, authorizations etc. to allow carrying out service maintenance. 

Thanks for your answer Julie. The main problem is that the company who lost the CE mark is not my company and I can not contact the notified body of Company A to ask what Company A needed to do. I am just trying to understand in general terms what happens when a company loses their CE mark and what are their responsibilities with the products that are already distributed in the market.  I tried to make a google search but for some reason it is not very easy to find a clear answer.

Is there any guidance or document which explains  this?

Thanks in advance.
Regards,

Carmen

Hi to Everyone,

I would like to make a question about how the suspension of the CE mark works exactly.

The company I work for, has currently bought the technology of another company (company A) which went in bankrupt and unfortunately, they also lost the CE mark due to not solving the non-conformities found by their notified body.

 We are currently trying to re-certify the whole device with the accessories but we are not quite sure what to do with the machines (mainly the generator) already in the market. The most expensive part is a steam generator, the rest of the parts are of one use only.

I have heard from another company that the generators could be used and sold if they were manufactured before Company A lost their CE mark, but to me this looks a little bit strange.  What is normally the process when a company gets their CE mark suspended?

Do they need to recall all the products and inform the clients?

Can the clients still use the generator if it was produced before the company A lost their CE mark? Or they can not use them?

Is there any path to take over this machines already in the market and rebuild them so they are under my company  (when we get the CE mark) and we can provide the maintenance?

This is quite a complicated situation and it would be really helpful to read some opinions if someone had a similar situation or if they are knowledgeable about this.  

Thanks a lot in advance,
Regards,