Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello all, 

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period? 


Thanks,
a lovely person puzzled by EU importation....

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period. 
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor). 
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....

This message was posted by a user wishing to remain anonymous

Great thanks Erik for your reply. Now it is clear for me. Thank you!!
Original Message:
Sent: 18-Nov-2021 02:32
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period.
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor).
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....

This message was posted by a user wishing to remain anonymous

Hi Erik,

May I ask -  if a company A has several subsidiaries in the EU and each of them is located in different  EU countries.  To make use of the sell off period, can company A 's subsidiary - Company B in Germany acting as the importer, then B transfers the ownership to other subsidiaries (e.g: company C/D as distributors) so as to "make the device available on the market' ? In  this case, i assume company C/D has the right to sell the products under the permitted "sell off period", correct？  

In addition, the EU Blue Guide mentions when placing the device on the market,  it does not require the physical handover of the product - does this allow the products to be saved in manufacturer's stock till the manufacturer know which EU distributor to sent? (The ownership transfer of EU importation and distribution will be done of course.)

For example, here's a UK manufacturer,  company B in Germany acting as the importer and company C in Italy is the fina distributor, when the process of ownership transfer (importation & distribution) is done, can this UK manufacturer directly ship the product to Company C in Italy? (Company B holds the importation records and no shipment in Germany). 

Great thanks!
Anon... 

Original Message:
Sent: 18-Nov-2021 02:32
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period.
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor).
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....

Hi anon, yes this is possible and happens all the time: local distributors get orders, send them to the Union importer or directly to the manufacturer, and the manufacturer delivers to the distributor directly. The importer does not necessarily need to take possession of the devices for them to be placed on the market for MDR purposes. Keep in mind however that if the devices are kept in manufacturer stock, this is a contra-indication of the devices having been placed on the market (see the list of situations in which a product is not placed on the market in the Blue Guide). Preferably in this scenario you would have the devices sitting in manufacturer stock with status as having been released from production and ready to be delivered, and marked per serial or batch as intended for the Union (not EU, MDR Union is bigger than the EU so why limit your options) distribution in the manufacturer ERP system. In your example you have company B 'acting as the importer' so you must have conclusive rationale why what company B does in the supply chain constitutes placing on the market (for example allocation of batches or serials of devices to specific distributor orders). You may find this article interesting for that purpose: https://www.raps.org/news-and-articles/news-articles/2019/10/implementation-of-shared-mdr-economic-operator-res

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 23-Nov-2021 11:17
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hi Erik,

May I ask -  if a company A has several subsidiaries in the EU and each of them is located in different  EU countries.  To make use of the sell off period, can company A 's subsidiary - Company B in Germany acting as the importer, then B transfers the ownership to other subsidiaries (e.g: company C/D as distributors) so as to "make the device available on the market' ? In  this case, i assume company C/D has the right to sell the products under the permitted "sell off period", correct？

In addition, the EU Blue Guide mentions when placing the device on the market,  it does not require the physical handover of the product - does this allow the products to be saved in manufacturer's stock till the manufacturer know which EU distributor to sent? (The ownership transfer of EU importation and distribution will be done of course.)

For example, here's a UK manufacturer,  company B in Germany acting as the importer and company C in Italy is the fina distributor, when the process of ownership transfer (importation & distribution) is done, can this UK manufacturer directly ship the product to Company C in Italy? (Company B holds the importation records and no shipment in Germany).

Great thanks!
Anon...

Original Message:
Sent: 18-Nov-2021 02:32
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period.
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor).
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....

This message was posted by a user wishing to remain anonymous

Hello Erik,

I wonder for above case: Company B as the importer, others as distributors - is it possible, that the manufacturer, Company B (importer) and company C sign off on a same agreement where specifies clearly that Company B is importer + the financial transaction will directly be processed from the manufacturer to Company C? 

Is this possible?  oOr the financial transaction must go through the importer first?
I would say no as Blue guide says the "ownership can be done for free of charge". (however, under "free of charge" mode, will this trigger the importer to pay for any tax?) 


Thank you very much. 

Best Regards,
Anon
Original Message:
Sent: 24-Nov-2021 02:19
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, yes this is possible and happens all the time: local distributors get orders, send them to the Union importer or directly to the manufacturer, and the manufacturer delivers to the distributor directly. The importer does not necessarily need to take possession of the devices for them to be placed on the market for MDR purposes. Keep in mind however that if the devices are kept in manufacturer stock, this is a contra-indication of the devices having been placed on the market (see the list of situations in which a product is not placed on the market in the Blue Guide). Preferably in this scenario you would have the devices sitting in manufacturer stock with status as having been released from production and ready to be delivered, and marked per serial or batch as intended for the Union (not EU, MDR Union is bigger than the EU so why limit your options) distribution in the manufacturer ERP system. In your example you have company B 'acting as the importer' so you must have conclusive rationale why what company B does in the supply chain constitutes placing on the market (for example allocation of batches or serials of devices to specific distributor orders). You may find this article interesting for that purpose: https://www.raps.org/news-and-articles/news-articles/2019/10/implementation-of-shared-mdr-economic-operator-res

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 23-Nov-2021 11:17
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hi Erik,

May I ask -  if a company A has several subsidiaries in the EU and each of them is located in different  EU countries.  To make use of the sell off period, can company A 's subsidiary - Company B in Germany acting as the importer, then B transfers the ownership to other subsidiaries (e.g: company C/D as distributors) so as to "make the device available on the market' ? In  this case, i assume company C/D has the right to sell the products under the permitted "sell off period", correct？

In addition, the EU Blue Guide mentions when placing the device on the market,  it does not require the physical handover of the product - does this allow the products to be saved in manufacturer's stock till the manufacturer know which EU distributor to sent? (The ownership transfer of EU importation and distribution will be done of course.)

For example, here's a UK manufacturer,  company B in Germany acting as the importer and company C in Italy is the fina distributor, when the process of ownership transfer (importation & distribution) is done, can this UK manufacturer directly ship the product to Company C in Italy? (Company B holds the importation records and no shipment in Germany).

Great thanks!
Anon...

Original Message:
Sent: 18-Nov-2021 02:32
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period.
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor).
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....

Hi anon, hard to say whether this will work. Keep in mind that you cannot get a group of companies together and then appoint roles (IMP, DIS) if you don't also have them agree what they will do to fit the definitions of placing on the market (for IMP) and making available (for DIS). Otherwise it's like sitting around the campfire agreeing everyone is an elephant - nice concept but no basis in reality.
The concepts of making availble and placing on the market are in the end determined by traceability and an economic operator taking (a degree of) responsibility for conformity of the device as it makes its way down the supply chain. The accountants and logistics people will release a bunch of tax voodoo on the supply chain for their own tax and customs purposes with flash ownership changes and whatnot, but for MDR and IVDR purposes it's all about who controls where which specific device goes and this is the core logic to be applied when looking for what economic operator has what role. If you want to shoehorn a specific entity in an importer role, the facts need to match the definition of importer and the underlying rationale should support this clearly.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands
------------------------------

Original Message:
Sent: 26-Nov-2021 04:05
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello Erik,

I wonder for above case: Company B as the importer, others as distributors - is it possible, that the manufacturer, Company B (importer) and company C sign off on a same agreement where specifies clearly that Company B is importer + the financial transaction will directly be processed from the manufacturer to Company C?

Is this possible?  oOr the financial transaction must go through the importer first?
I would say no as Blue guide says the "ownership can be done for free of charge". (however, under "free of charge" mode, will this trigger the importer to pay for any tax?)


Thank you very much.

Best Regards,
Anon
Original Message:
Sent: 24-Nov-2021 02:19
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, yes this is possible and happens all the time: local distributors get orders, send them to the Union importer or directly to the manufacturer, and the manufacturer delivers to the distributor directly. The importer does not necessarily need to take possession of the devices for them to be placed on the market for MDR purposes. Keep in mind however that if the devices are kept in manufacturer stock, this is a contra-indication of the devices having been placed on the market (see the list of situations in which a product is not placed on the market in the Blue Guide). Preferably in this scenario you would have the devices sitting in manufacturer stock with status as having been released from production and ready to be delivered, and marked per serial or batch as intended for the Union (not EU, MDR Union is bigger than the EU so why limit your options) distribution in the manufacturer ERP system. In your example you have company B 'acting as the importer' so you must have conclusive rationale why what company B does in the supply chain constitutes placing on the market (for example allocation of batches or serials of devices to specific distributor orders). You may find this article interesting for that purpose: https://www.raps.org/news-and-articles/news-articles/2019/10/implementation-of-shared-mdr-economic-operator-res

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 23-Nov-2021 11:17
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hi Erik,

May I ask -  if a company A has several subsidiaries in the EU and each of them is located in different  EU countries.  To make use of the sell off period, can company A 's subsidiary - Company B in Germany acting as the importer, then B transfers the ownership to other subsidiaries (e.g: company C/D as distributors) so as to "make the device available on the market' ? In  this case, i assume company C/D has the right to sell the products under the permitted "sell off period", correct？

In addition, the EU Blue Guide mentions when placing the device on the market,  it does not require the physical handover of the product - does this allow the products to be saved in manufacturer's stock till the manufacturer know which EU distributor to sent? (The ownership transfer of EU importation and distribution will be done of course.)

For example, here's a UK manufacturer,  company B in Germany acting as the importer and company C in Italy is the fina distributor, when the process of ownership transfer (importation & distribution) is done, can this UK manufacturer directly ship the product to Company C in Italy? (Company B holds the importation records and no shipment in Germany).

Great thanks!
Anon...

Original Message:
Sent: 18-Nov-2021 02:32
From: Erik Vollebregt
Subject: Importer/Distributor - Sell off Period

Hi anon, a lot is being said but not always in very precise statements. If the device is in the stock of the importer, this does not automatically mean that the device has been placed on the market, although it may well be placed on the market if the facts fit the concept of placing on the market as defined in the MDR and explained in detail in the Blue Guide. For example, if the device is in the stock of the importer and subject to an order by a Union (the MDR applies in the Union, which is bigger than the EU - it comprises the EU, EEA member states that are not EU member states and Turkey) customer it is placed on the market. If the device is part of importer stock that can also be exported (e.g. to Africa) the device is not placed on the market.
You are right that devices not placed on the market cannot make use of the sell off period.
An importer cannot also have the role of distributor for the same device (people often confuse the MDR defined concept of distributor with the colloquial term of distributor, which are different things), as these exclude each other in the MDR for the same device. An importer can be importer for one device and distributor for another device (if the underlying fact pattern fits the MDR definitions for importer and distributor).
If the problem is that you want stock at the importer to be subject to the sell-off period, best way is to make sure that the importer's IT systems define the specific devices concerned in stock as earmarked for distribution on the Union (not EU) market only and that they are allocated to existing orders from distributors or customers in the Union, even if they will only be supplied later.

------------------------------
Erik Vollebregt
Partner
Amsterdam
Netherlands

Original Message:
Sent: 16-Nov-2021 13:57
From: Anonymous Member
Subject: Importer/Distributor - Sell off Period

This message was posted by a user wishing to remain anonymous

Hello all,

It is said,  if the device is in the stock of EU importer, it is not considered as "placed on the market" due to the device is not yet being offered for distribution, consumption of use.... In this case, it seems the device cannot make use of the selloff period. 

However,  what if this importer also has another role - EU distributor, can we argue the device is "in the stock of distributor" and then make use of the sell off period?


Thanks,
a lovely person puzzled by EU importation....