Clarity from EC on Importer/Distributor roles in MDR

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I recevied the following email to hopefully clarify the importer and distributor roles in MDR

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



________________________________________________________________________________________________
<NAME REDACTED>

Policy and Legal Officer Medical Devices

European Commission
Directorate-General for Health and Food Safety (DG SANTE)

Unit B.6 - Medical Devices, Health Technology Assessment
 

Roland chung

Trusted Information Resource
I recevied the following email to hopefully clarify the importer and distributor roles in MDR

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



________________________________________________________________________________________________
<NAME REDACTED>

Policy and Legal Officer Medical Devices

European Commission
Directorate-General for Health and Food Safety (DG SANTE)

Unit B.6 - Medical Devices, Health Technology Assessment

But how about the end user receives a device directly from a manufacturer located outside the EU?
 

Philip B

Quite Involved in Discussions
My understanding is that if a manufacturer based outside of the EU supplies directly to an end user in the EU then the end user becomes the importer by default and the importer obligations detailed in the MDR become applicable to them. A role they probably wouldn't want or understand. This could be picked up on if you don't have an EU importer name and address on your product labels.
 

Raisin picker

Quite Involved in Discussions
I'm not an expert in that field, but I'd say there is no importer in that case. The importer obligations are to be fulfilled by the manufacturer and the AR.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Can you help clarify this with commission, considering you are already in communication? I will appreciate it.

the commentary below is taken from another forum I frequent.

This regulation clarifies that when a non-EU entity sends a product direct to an end user in the EU, there is no importer, and that the non-EU entity is responsible for 'making the product available on the market' (rather than for 'placing on the market').

It also identifies that for any product that is available on the EU market, for it to be 'legal', there must be an entity ('economic operator') that takes responsibility for it within the EU. There are four types of economic operator identified that are able to take on this responsibility:

1. A manufacturer established in the EU
2. An importer (by definition established in the EU), where the manufacturer is not established in the Union
3. An authorised representative (by definition established in the EU)
4. A fulfilment service provider established in the EU where there is no manufacturer, importer or authorised representative established in the Union

'Fulfilment service provider' is defined as: 'any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services, and any other postal services or freight transport services'
When there is no importer or fulfilment service provider for a product from outside of the EU, the authorised representative must take on responsibility for the product in the EU.

With this background, turning now to your questions:

In the first scenario, there is no importer or fulfilment service provider, because the UK company is making the device available on the EU market by supplying it directly to an end user (presumed to be via a postal or parcel delivery service). The French manufacturer will be responsible for it once it is with the end user because it fulfils one of the required economic operator roles required by Regulation 2019/1020, as an EU manufacturer, even though it did not 'place the device on the market'.

In the second scenario, a similar situation exists except that the German authorised representative now must assume responsibility for the device once it is with the end user, because it fulfils one of the required economic operator roles in 2019/1020, there being no EU manufacturer, importer or fulfilment service provider.

One final point, the date of application of Regulation 2019/1020 is 16 July 2021. Non-EU device manufacturers may need to review their agreements with importers and authorised representatives to take account of this new regulation.
 

Roland chung

Trusted Information Resource
the commentary below is taken from another forum I frequent.

This regulation clarifies that when a non-EU entity sends a product direct to an end user in the EU, there is no importer, and that the non-EU entity is responsible for 'making the product available on the market' (rather than for 'placing on the market').

It also identifies that for any product that is available on the EU market, for it to be 'legal', there must be an entity ('economic operator') that takes responsibility for it within the EU. There are four types of economic operator identified that are able to take on this responsibility:

1. A manufacturer established in the EU
2. An importer (by definition established in the EU), where the manufacturer is not established in the Union
3. An authorised representative (by definition established in the EU)
4. A fulfilment service provider established in the EU where there is no manufacturer, importer or authorised representative established in the Union

'Fulfilment service provider' is defined as: 'any natural or legal person offering, in the course of commercial activity, at least two of the following services: warehousing, packaging, addressing and dispatching, without having ownership of the products involved, excluding postal services, and any other postal services or freight transport services'
When there is no importer or fulfilment service provider for a product from outside of the EU, the authorised representative must take on responsibility for the product in the EU.

With this background, turning now to your questions:

In the first scenario, there is no importer or fulfilment service provider, because the UK company is making the device available on the EU market by supplying it directly to an end user (presumed to be via a postal or parcel delivery service). The French manufacturer will be responsible for it once it is with the end user because it fulfils one of the required economic operator roles required by Regulation 2019/1020, as an EU manufacturer, even though it did not 'place the device on the market'.

In the second scenario, a similar situation exists except that the German authorised representative now must assume responsibility for the device once it is with the end user, because it fulfils one of the required economic operator roles in 2019/1020, there being no EU manufacturer, importer or fulfilment service provider.

One final point, the date of application of Regulation 2019/1020 is 16 July 2021. Non-EU device manufacturers may need to review their agreements with importers and authorised representatives to take account of this new regulation.
Thank you, but it seems that the discussion you posted is not MDR related.
 

Philip B

Quite Involved in Discussions
I think that whoever first makes the product available on the EU market is the importer. I don't think this can be the AR, it would be a conflict of interest and I don't think ARs would want this role. It has to be an EU-based importer otherwise the end-user becomes the importer by default. Very little case history has emerged on this yet so we are all guessing but this is my best understanding.
 

Raisin picker

Quite Involved in Discussions
Art. 2 (28):
‘placing on the market’ means the first making available of a device, other than an investigational device, on the Union market;
Art. 2 (33):
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;

My interpretation is: If an end user buys the device directly from a seller outside the EU, there is no importer (as per MDR). The end user does not make the device available, and the seller is not established within the EU.
Please show me where I'm wrong. My logic has already been proven wrong, in other cases, by some MDCG documents :(

If I (located in EU) buy a hip implant pulse oxymeter for personal use via Amazon marketplace from a manufacturer in PRC, the device has to have a valid CE mark. But the seller is outside EU, and I'm not going to make it available. No importer. Well, I'll be considered importer for customs, but not acc. to MDR.
 
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