Regulatory Open Forum

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

I believe this topic was well-covered in the other thread (to which I replied more than once), although I did want to point out an error in Kevin's response above: importers are required to "keep a register of complaints, of non-conforming devices and of recalls and withdrawals" (see Art. 13 para. 6), which is the same for distributors (Art. 14 para. 5), albeit alongside different context (for instance, the obligation to forward complaints or reports, which appears in a separate paragraph (8) in Art. 13).

Although I concur that the legal concepts of importer and distributor are indeed distinct, if an entity is already serving as an importer and fulfilling obligations in Art. 13, they are already fulfilling the responsibilities of a distributor in practice, thus making the question moot (even if one did have to hypothetically meet both importer obligations in Art. 13 and distributor obligations in Art. 14 - which I agree is not a legal possibility). [Note that I don't see any question about the inverse scenario, i.e. distributors having to fulfill importer obligations, which would necessarily be more problematic given the more rigorous requirements for importers.]

Thank you all for your insights. I can see this topic can offer different views and interpretations, so I'm glad I asked the questions in the first place!

I have been studying the blue guide, specifically paragraphs 2.2 and 2.3 and have been trying to apply it to our current situation which is the manufacturer is based outside of the EU. The importer that will be utilised is part of the same company (subsidiary) but based in the Union. This importer shall be purchasing and storing IVDs imported from us and selling direct to customers as well as onto 3^rd party distributors in the Union.

so, clearly defined is the terminology:

Placing on the market: A product is placed on the market when it is made available for the first time on the Union market. This is done by Manufacturers (EU based) or Importers (for non-EU manufacturers). So, in our case, the importer will be placing on the market on our behalf

Making available on the market: A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

There are additional points recorded under these headings that I think need some clarity. Below are the points I refer to:

When a manufacturer or an importer supplies a product to a distributor (50) or an end-user for the first time, the operation is always labelled in legal terms as 'placing on the market'. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.

So based on this definition, only a 3^rd party distributor can actually make the product available on the market. In other words, only once the product is shipped from the Importer to a third-party distributor. The importer can only place on the market and not actually make available (distribute)?

If that's so, then I think the question that it raises is at exactly which point the product is considered placed on the market. I take the point in section 2.3 from the blue guide:

Placing on the market is considered not to take place where a product is:

• in the stocks of the manufacturer (or the authorised representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonisation legislation.

So, in our case, the product is manufactured outside of the EU, QC released and shipped as the final product to the importer for continued supply. So, I would term that as in the stocks of the importer, but it is able to be supplied for distribution or consumption. Thus, when it is received by the importer and stocked, it is considered placed on the market. Is that agreed? The reason this is particularly important is due to article 110 (as it is currently written, without the IVDR proposal details):

The strategy for us was to stock up our importer with self-certified IVDs so they can continue to be supplied past May2022 whilst IVDR certification was sought. When this was being planned, the consensus was that this was acceptable as the product was considered as in the EU supply chain. For our European Manufacturers however, they had to transfer ownership to a 3^rd party distributor to achieve the same goal.

So, to break it down further, these are the points I am trying to clarify:

• Can we utilise the strategy of stocking up our Importer with our self-certified IVDs prior to May22 with the intent to supply to end users and or distributors? Does this meet the requirement of placed on the market prior to May22? Or will the Importer need to use a 3^rd party distributor to meet this requirement?
• Our EU Importer – we as the manufacturer only need to control them as an importer as even though they shall ship product to customers or distributors, they in themselves cannot be termed as a distributor for the products they import? The importer will need to have agreements with 3^rd party distributors, and we should audit that etc
• In the instance when the importer ships directly to a customer, there will be no distributor involved, in other words the Article 14 is not applicable?

Thanks all

Thank you all for your insights. I can see this topic can offer different views and interpretations, so I'm glad I asked the questions in the first place!

I have been studying the blue guide, specifically paragraphs 2.2 and 2.3 and have been trying to apply it to our current situation which is the manufacturer is based outside of the EU. The importer that will be utilised is part of the same company (subsidiary) but based in the Union. This importer shall be purchasing and storing IVDs imported from us and selling direct to customers as well as onto 3^rd party distributors in the Union.

so, clearly defined is the terminology:

Placing on the market: A product is placed on the market when it is made available for the first time on the Union market. This is done by Manufacturers (EU based) or Importers (for non-EU manufacturers). So, in our case, the importer will be placing on the market on our behalf

Making available on the market: A product is made available on the market when supplied for distribution, consumption or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge.

There are additional points recorded under these headings that I think need some clarity. Below are the points I refer to:

When a manufacturer or an importer supplies a product to a distributor (50) or an end-user for the first time, the operation is always labelled in legal terms as 'placing on the market'. Any subsequent operation, for instance, from a distributor to distributor or from a distributor to an end-user is defined as making available.

So based on this definition, only a 3^rd party distributor can actually make the product available on the market. In other words, only once the product is shipped from the Importer to a third-party distributor. The importer can only place on the market and not actually make available (distribute)?

If that's so, then I think the question that it raises is at exactly which point the product is considered placed on the market. I take the point in section 2.3 from the blue guide:

Placing on the market is considered not to take place where a product is:

• in the stocks of the manufacturer (or the authorised representative established in the Union) or the importer, where the product is not yet made available, that is, when it is not being supplied for distribution, consumption or use, unless otherwise provided for in the applicable Union harmonisation legislation.

So, in our case, the product is manufactured outside of the EU, QC released and shipped as the final product to the importer for continued supply. So, I would term that as in the stocks of the importer, but it is able to be supplied for distribution or consumption. Thus, when it is received by the importer and stocked, it is considered placed on the market. Is that agreed? The reason this is particularly important is due to article 110 (as it is currently written, without the IVDR proposal details):

The strategy for us was to stock up our importer with self-certified IVDs so they can continue to be supplied past May2022 whilst IVDR certification was sought. When this was being planned, the consensus was that this was acceptable as the product was considered as in the EU supply chain. For our European Manufacturers however, they had to transfer ownership to a 3^rd party distributor to achieve the same goal.

So, to break it down further, these are the points I am trying to clarify:

• Can we utilise the strategy of stocking up our Importer with our self-certified IVDs prior to May22 with the intent to supply to end users and or distributors? Does this meet the requirement of placed on the market prior to May22? Or will the Importer need to use a 3^rd party distributor to meet this requirement?
• Our EU Importer – we as the manufacturer only need to control them as an importer as even though they shall ship product to customers or distributors, they in themselves cannot be termed as a distributor for the products they import? The importer will need to have agreements with 3^rd party distributors, and we should audit that etc
• In the instance when the importer ships directly to a customer, there will be no distributor involved, in other words the Article 14 is not applicable?

Thanks all

Dear Mr Panek,

To answer to your question, it is necessary to refer to the applicable definitions and requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) concerning importers and distributors (Article 2(33) and (34), Articles 13 and 14). According to them, it is clear that the respective roles, actions and obligations are different. The importer as such places devices on the EU/EEA market, it is to say, the importer make devices available on the EU/EEA market for the first time, while the distributor as such makes available devices on the market for the second and successive times until reaching the end user. Therefore, a person as economic operator may not be at the same time "importer" and "distributor", considering in particular the explicit indication of the MDR in the definition of distributor as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service" (emphasis added). A person as economic operator will assume each specific role, and related obligations, according to the specific action it carries out in the supply chain of the device. If the person receives a device from a manufacturer located outside the EU and places it on the EU/EEA market (it is to say, it makes the device available on the EU/EEA market for the first time), then that person acts as the importer of the device. On the contrary, if the person receives the device from a manufacturer located in the EU/EEA, or from an importer, or from another distributor, then that person acts as a distributor of the device. The importer may indeed directly supply the device to the end users, but it keeps the obligations of the importer, without "downgrading" its obligations to those of the distributor.

For your information, the Subgroup on Market Surveillance of the Medical Device Coordination Group (MDCG) is currently working on a guidance document "Q&A on Importers & Distributors" (see the Ongoing guidance development and deliverables of MDCG Subgroups – October 2021). When such a document is finalised and published in the Commission's website guidance for medical devices (likely by the end of the year), it will provide useful guidance on several questions related to importers and distributors. However, for the time being, you may also refer to the horizontal guidance document "The 'Blue Guide' on the implementation of EU product rules", in particular sections 3.3 and 3.4.

Best regards

Dear Mr Panek,

To answer to your question, it is necessary to refer to the applicable definitions and requirements of the Medical Devices Regulation (EU) 2017/745 (MDR) concerning importers and distributors (Article 2(33) and (34), Articles 13 and 14). According to them, it is clear that the respective roles, actions and obligations are different. The importer as such places devices on the EU/EEA market, it is to say, the importer make devices available on the EU/EEA market for the first time, while the distributor as such makes available devices on the market for the second and successive times until reaching the end user. Therefore, a person as economic operator may not be at the same time "importer" and "distributor", considering in particular the explicit indication of the MDR in the definition of distributor as "any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service" (emphasis added). A person as economic operator will assume each specific role, and related obligations, according to the specific action it carries out in the supply chain of the device. If the person receives a device from a manufacturer located outside the EU and places it on the EU/EEA market (it is to say, it makes the device available on the EU/EEA market for the first time), then that person acts as the importer of the device. On the contrary, if the person receives the device from a manufacturer located in the EU/EEA, or from an importer, or from another distributor, then that person acts as a distributor of the device. The importer may indeed directly supply the device to the end users, but it keeps the obligations of the importer, without "downgrading" its obligations to those of the distributor.

For your information, the Subgroup on Market Surveillance of the Medical Device Coordination Group (MDCG) is currently working on a guidance document "Q&A on Importers & Distributors" (see the Ongoing guidance development and deliverables of MDCG Subgroups – October 2021). When such a document is finalised and published in the Commission's website guidance for medical devices (likely by the end of the year), it will provide useful guidance on several questions related to importers and distributors. However, for the time being, you may also refer to the horizontal guidance document "The 'Blue Guide' on the implementation of EU product rules", in particular sections 3.3 and 3.4.

Best regards