Regulatory Open Forum

Dear Regulatory Professionals,

Does anyone have experience with direct sales to end users from outside Europe?

I would like a confirmation that a European Importer is not required when medical devices are sold directly to end users.

Looking at the MDR, I understand that a European importer is required if a medical device enters the Europe and is sold through Distributors. While only an EC REP is mandated in case of a product is sold directly to the end user.

Could you help?

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Mauro
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Mauro,

In reference to the Blue Guide, basically if products are sold to the end user directly from outside the EU (a Manufacturer located outside the European Union), then the Manufacturer essentially becomes the Importer.  Though in reality when looking at the EU MDR regulation, there ends up being some shared responsibility between the Manufacturer and the end user.  This has been understood and there are some examples in the Blue Guide from this perspective.  However, if the product is being sold through a Distributor, then in almost all cases, an Importer would be needed, because the Distributor would not be considered the end user.

An Authorised Representative (EU Rep) does not really have any relation to how products are sold.  If any Manufacturer is located physically outside the European Union (EFTA), they would need an Authorised Representative physically located in the Union/EFTA.  This does not matter whether products are sold through Distributors or directly to end users.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 01-Jun-2023 06:16
From: Mauro Rinaldi
Subject: European Importer requirements for Medical Devices sold directly to end user

Dear Regulatory Professionals,

Does anyone have experience with direct sales to end users from outside Europe?

I would like a confirmation that a European Importer is not required when medical devices are sold directly to end users.

Looking at the MDR, I understand that a European importer is required if a medical device enters the Europe and is sold through Distributors. While only an EC REP is mandated in case of a product is sold directly to the end user.

Could you help?

------------------------------
Mauro
------------------------------

Thank you for your reply, Richard. It is clear and complete, as usual. 

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Mauro
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Original Message:
Sent: 04-Jun-2023 03:11
From: Richard Vincins
Subject: European Importer requirements for Medical Devices sold directly to end user

Mauro,

In reference to the Blue Guide, basically if products are sold to the end user directly from outside the EU (a Manufacturer located outside the European Union), then the Manufacturer essentially becomes the Importer.  Though in reality when looking at the EU MDR regulation, there ends up being some shared responsibility between the Manufacturer and the end user.  This has been understood and there are some examples in the Blue Guide from this perspective.  However, if the product is being sold through a Distributor, then in almost all cases, an Importer would be needed, because the Distributor would not be considered the end user.

An Authorised Representative (EU Rep) does not really have any relation to how products are sold.  If any Manufacturer is located physically outside the European Union (EFTA), they would need an Authorised Representative physically located in the Union/EFTA.  This does not matter whether products are sold through Distributors or directly to end users.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 01-Jun-2023 06:16
From: Mauro Rinaldi
Subject: European Importer requirements for Medical Devices sold directly to end user

Dear Regulatory Professionals,

Does anyone have experience with direct sales to end users from outside Europe?

I would like a confirmation that a European Importer is not required when medical devices are sold directly to end users.

Looking at the MDR, I understand that a European importer is required if a medical device enters the Europe and is sold through Distributors. While only an EC REP is mandated in case of a product is sold directly to the end user.

Could you help?

------------------------------
Mauro
------------------------------

In addition to the comment by Richard Vincins, I would like to add that in the case of direct supplies the importer cannot be identified under the current MDR rules. Therefore, one could do this without identification of a regulatory importer. However, there are two consequences that may make a company still decide to appoint a regulatory importer:

1. Under the new liability directive, the authorized representative may see an extra liability put upon them. They may decide not to accept that.
2. A 'missing' importer may draw attention by the authorities. Of course, this position can be justified, but I strongly recommend not to draw unnecessary attention.

For these situations there are some companies that provide regulatory importer services. Reach out if you want me to bring you into contact with an organization that provides good service with a lot of added value.

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Ronald Boumans
MDR Expert
Super PRRC
Netherlands
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Original Message:
Sent: 01-Jun-2023 06:16
From: Mauro Rinaldi
Subject: European Importer requirements for Medical Devices sold directly to end user

Dear Regulatory Professionals,

Does anyone have experience with direct sales to end users from outside Europe?

I would like a confirmation that a European Importer is not required when medical devices are sold directly to end users.

Looking at the MDR, I understand that a European importer is required if a medical device enters the Europe and is sold through Distributors. While only an EC REP is mandated in case of a product is sold directly to the end user.

Could you help?

------------------------------
Mauro
------------------------------

Dear Mauro,

I wanted to address some of the confusion surrounding the topic of importers and clarify a few points and please let me know whether it is helpful to you.

In the European Union, it is important to note that both businesses and individuals have the ability to import products. Conversely, companies or individuals outside the EU are considered exporters to the EU. These trade rules are commonly understood.

To give you a practical example, if I were to purchase a product from a third country, I would be responsible for importing it into the EU. Depending on the value of the product, I might need to declare it to customs. It's worth mentioning that certain regulations are in place to ensure that forbidden products are not imported. These regulations apply to everyone, irrespective of their status.

However, it is crucial to understand that the requirements of an Importer, as defined in the MDR/IVDR, only come into effect when the device is being placed on the market. This means that the device is being made available to others for the first time.

There seems to be some misconception surrounding the need for a designated importer or a written agreement. It clear that neither of these requirements applies to Importers. The designation of an EC REP (European Authorized Representative) and the necessity of a written agreement only apply to the EC REP.

The responsibility of the Importer under the MDR is determined simply by the action of importing and the placing the device on the market. To shed further light on this matter, I would like to quote Swissmedic, which provides excellent guidance on this topic.

"Importer (Art. 4 para. 1 let. h MedDO, Art. 4 para. 1 let. g IvDO)

An importer is not "designated", its role arising instead from the activity that is carried out when a natural or legal person in Switzerland places a device from another country on the Swiss market."

It is important to note that the definition of the Importer in the MedDo aligns with the MDR, but with certain adjustments to specifically cater to Switzerland. To ensure a comprehensive understanding, I encourage you to personally verify the requirements and associated guidance.

Currently, at the EU level, we rely on the Medical Device Coordination Group (MDCG) and the blue guide as valuable resources. These sources are as well confirmed from national guidance, including the Irish Competent Authority (CA) and Switzerland. Utilizing these resources will prove immensely helpful in finding answers to any lingering questions you may have concerning this topic.

Please take the time to explore these references, as they will undoubtedly assist you in forming your own well-informed conclusion.

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Ludger Moeller
President, MDSS GmbH
l.moeller@mdssar.com
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Original Message:
Sent: 01-Jun-2023 06:16
From: Mauro Rinaldi
Subject: European Importer requirements for Medical Devices sold directly to end user

Dear Regulatory Professionals,

Does anyone have experience with direct sales to end users from outside Europe?

I would like a confirmation that a European Importer is not required when medical devices are sold directly to end users.

Looking at the MDR, I understand that a European importer is required if a medical device enters the Europe and is sold through Distributors. While only an EC REP is mandated in case of a product is sold directly to the end user.

Could you help?

------------------------------
Mauro
------------------------------