The difference is in the action.
An importer is the first person (natural or legal) that places an individual device from a third country, onto the Union market. Further explanation on the concept of ‘placing on the market’ can be found here.
The distributor is any person (natural or legal) in the supply chain, that is between the EU manufacturer/EU importer and the end user. i.e., the person that is involved after the device has already been placed on the Union market, and before it is supplied to the end user.
Each respective role is per individual device, not type of product. i.e., the action occurs per transaction that results in the change of ownership of a finished/manufactured device.
The Irish Competent Authority published a table which may also be useful (page 2):
Per Article 13, the importer shall meet the following requirements (high-level):
*EUDAMED is currently voluntary. For information on the most current registration deadlines, please read: EUDAMED Overview
Per Article 25 (MDR)/Article 22 (IVDR) ‘Identification within the supply chain’:
This includes that:
“Economic operators shall store and keep, preferably by electronic means, the UDI of the devices which they have supplied or with which they have been supplied, if those devices belong to: (a) class III implantable devices; (b) the devices, categories or groups of devices determined by a measure referred to in point (a) of paragraph 11.
There may be additional local Competent Authority requirements, such as obtaining an importer license.
For more information on EU registration requirements, please read: EU Registration Requirements Tool
The distributor has similar requirements as the importer, with some differences.
Unlike the importer, distributor does not need to:
Distributors are additionally responsible for:
Please see Article 14 for the full list of requirements.
Like importers, distributors may be subject to additional local Competent Authority requirements. For example, obtaining a distributor’s license or confirming which products they are placing on that individual member state’s market.
While some manufacturers do intentionally ‘appoint’ an importer, ultimately the ‘appointment’ is out of their control. I.e., an importer is a role that occurs whether the manufacturer makes an active decision to ‘designate’ that importer or not.
Per the MDR/IVDR, the person (natural or legal) that first places a device from a third country onto the Union market, becomes the importer. Therefore, it is a de facto role that occurs whether the person (manufacturer or importer) wants or intends it.
For example, let us say you formally appoint a company to act as your EU importer. Your company implements processes to ensure it does not unintentionally sell/transfer ownership of products to any other EU company. However, your distributor in the UK sells your product to their EU customer. That EU customer then becomes the EU importer of the product, as that entity is first placing the product from a third country onto the Union market. This is despite your separate EU importer ‘appointment’ and internal processes. That EU customer must now meet the importer obligations, including identifying themselves with the device.
MDCG 2021-27 (page 5) addresses how an importer should handle a situation where the devices are already labeled with another importer’s information.
“What should an importer do in the case where an individual device already mentions another importer’s details on its packaging?”
“In the unusual case where details of another importer already appear on the packaging of an individual device (for example, the individual device has been exported and then reintroduced to the Union market), the importer should verify if the individual device has previously been placed on the Union market. This may be done by contacting the manufacturer. The importer should replace any previous importer details with their own, if having investigated the issue, they determine themselves to be the correct importer. The label with the previous details will be void.”
So, while you may ‘appoint’ an importer, if another EU entity first places your devices onto the Union market, they become the importer for those products. They must add their own information to the devices and meet all the other obligations outlined in the regulation.
The MDR/IVDR does not require a mandate between the manufacturer and importer, unlike for the manufacturer and authorized representative.
Manufacturers may voluntarily put an agreement in place with an importer for other reasons.
For example, they may have an agreement covering commercial issues, such as sales and payment terms. And in that agreement, the manufacturer may further require importers to meet their requirements under MDR/IVDR, such as ensuring the importer’s information is supplied with the product, device traceability, etc. The agreement may also allow the manufacturer to cancel the agreement if the importer does not meet its regulatory obligations. Further, if the Notified Body asks to confirm if/how the manufacturer has controls in place over their economic operators, this agreement could be presented.
That said, this kind of formal contract is not required by the regulation. Whether an agreement is in place or not, importers/distributors are legally obligated to meet their minimum requirements under the MDR/IVDR. And in some cases, a separate formal importer agreement may not be practical or possible. In this case, manufacturers may consider adding applicable language to its standard purchase agreement or Terms & Conditions.
Translation requirements for medical devices & IVDs in Europe, UK and Switzerland. Plus, if exemptions are allowed.
It is the importer’s obligation to ensure that their information is appropriately supplied with the device.
Per MDCG 2021-27 (page 5):
“Who is responsible for indicating the importer on the device, its packaging or accompanying documentation?”
“Importers are responsible for including their information on the device, its packaging or in accompanying documentation in accordance with Article 13(3) of the Regulations. The importer may add this information themselves or sub-contract this task to the manufacturer, however the importer remains responsible for the correct execution of the obligation, regardless of the means chosen.”
This means the manufacturer may ship products without the importer information applied. The importer would then be required to include their details prior to placing the products onto the market.
Per MDCG 2021-27:
“Whilst the inclusion of the importer’s details before the device has physically entered the Union is not mandatory, the importer’s details must be included on the device (or on its packaging, or in a document accompanying the device) when the device is placed on the Union market (i.e. the first making available). The absence of the importer’s details at customs control should therefore not be considered as a non-compliance with the Regulations.”
Therefore, while the importer and manufacturer can mutually agree that the manufacturer will add this information to the labeling, it is ultimately the importer’s obligation to ensure that the information is correctly applied.
MDR/IVDR Article 13(3) requires that the importer’s details be provided on the product, the packaging or in a document accompanying the device.
MDCG 2021-27 (page 5) states that the ‘accompanying documentation’ with the importer’s information may be separate from, or affixed to, the individual device. It can be a sticker affixed to the label or a separate leaflet. The main point is that it must accompany the individual device throughout the supply chain and reach the end user.
The accompanying documentation should allow the importer to be located and contacted, and allow healthcare professionals, patients, and users to report any suspected incidents to the importer.
The importer symbol is available in EN ISO 15223-1:2021, which has been harmonized under the MDR and IVDR. Therefore, this symbol may be used on labeling without having to be further defined.
Companies may purchase a copy of EN ISO 15223-1:2021 for the full list of European harmonized symbols.
Otherwise, there are multiple places to obtain a copy of the importer symbol, such as MedTech Europe’s ‘Use of Symbols to Indicate Compliance with the MDR’.
For more information, please read: List of MDR/IVDR Harmonized Standards & Common Specifications
No, the distributor does not need to identify themselves with the device. Instead, their responsibility is to ensure that the importer has been properly identified with the device.
That said, the distributor may voluntarily be added to the labeling. This may help ensure they are correctly differentiated from the importer.
If the distributor information is added, there is a harmonized symbol in EN ISO 15223-1:2021 that may be used.
An importer is a person that places a device from a third-country onto the Union market. An EU manufacturer will not have an importer because they 1) are not from a third country and 2) will (presumably) be the first person to place the device on the Union market.
Therefore, this question is answered more specifically as: Can a non-EU company set up a subsidiary to act as the EU importer?
The answer to that is “yes”. There is nothing in the Regulation that prevents it, and the MDCG guidance on importers and distributors does not address this topic. Further, there are many examples of companies who have set-up this infrastructure, as seen in EUDAMED.
That said, companies may want to consider the original intent of the MDR/IVDR when doing so. The importer is tasked with ensuring that the manufacturer has met the conformity assessment requirements. Further, the importer should report the manufacturer if they have any “reason to believe that the device presents a serious risk or is a falsified device”. There is an obvious conflict of interest, when the company tasked with this obligation, is a subsidiary of the company they must report.
If manufacturers opt to set-up an EU subsidiary, they may want to consider how to properly address the responsibilities between the two economic operators. For example, if the importer is inspected by its national competent authority, can it defend that the checks-and-balances are not compromised? Is the importer sufficiently enabled to meet its obligations, including to report a non-compliance against its own parent company?
It depends on what the 3PL has been contracted to do. Per MDCG 2021-27 (page 6):
“Some 3PL companies which provide transportation services or hold devices on a consignment basis only (i.e. where devices are held at a site by the 3PL, but the 3PL does not have legal ownership of those devices), may not be considered an importer provided there is a clearly defined agreement between both parties setting out the responsibilities of each party.
The importer is the natural or legal person meeting the definition of Article 2(33) MDR/Article 2(26) IVDR, with ownership, possession or any other property right over the device.
Although transportation or storage activities may be subcontracted outside of the importer’s organisation, the importer retains responsibility over storage and transport conditions and as such, must ensure the sub-contractor’s conditions do not jeopardise compliance with the general safety and performance requirement of Annex I of the Regulations (see Article 13(5) of the Regulations).”
The short conclusion is that the end user that purchased the device likely does not take on the obligations of the importer.
Read below for full rationale.
From the perspective of direct sales to an end user, Section 3.8 of the Blue Guide states:
“The end user is any natural or legal person residing or established in the Union, to whom a product has been made available either as a consumer outside of any trade, business, craft or profession or as a professional end user in the course of its industrial or professional activities.
Union harmonisation legislation does not create obligations for the end-users of the products in their scope.
This is the case even when there are no responsible economic operators present within the EU (for example, in the context of products sold online and for which an economic operator under Article 4 of Regulation (EU) 2019/1020 [general EU legislation on market surveillance and compliance of products] is not required. The term thus covers both professional users and consumers.”
Regulation (EU) 2019/1020, cited above, indicates that an EU economic operator may by default assume additional responsibilities, in the absence of other EU economic operators. However, it also states that Article 4 is only applicable to certain legislation, for which the MDR/IVDR are not included.
It could be considered that there is no EU importer (as defined by the MDR/IVDR) in this situation.
Therefore, manufacturers could opt to draft a rationale as to why there is no EU importer for direct sales to end users. This could then be presented to the notified body or competent authority in discussions regarding the supply chain and economic operator roles, if/when applicable.
The other option for companies that have a high volume of direct sales (whether the product is physically shipped or remotely downloaded) is to work with a third-party company to act as the importer for these products. This would remove those uncertainties.
That said, the EU Commission themselves have created this uncertainty by not answering this question in any MDR/IVDR specific guidance documents. And it should therefore be reasonable to conclude that manufacturers will create a rationale based on the materials that are currently available.
MDCG 2021-27 is on the schedule to be updated in 2023 but has not yet been reissued. We can only hope that reissued guidance more specifically addresses this question.
Per MDCG 2021-27, yes, it is possible that individual shops, pharmacies, retailers and other persons can be importers or distributors under the MDR/IVDR.
“A distributor is 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 (see Article 2(34) MDR/Article 2(27) IVDR). As such, individual shops, pharmacies or retailers or other natural or legal persons meeting this definition, are considered distributors.
For example, a community pharmacy, an individual shop, retailer or other person, which buys and then sells type II medical face masks to customers (whether online or physically), such as other shops or companies or private individuals, are considered to supply medical devices and thereby fall within the definition of a distributor. These entities will be expected to comply with Article 14 of the Regulations and any applicable national registration requirements.
Furthermore, these operators will assume the role and responsibilities of an importer if they obtain the device directly from a non-EU based manufacturer or distributor and are expected to comply with Article 13 of the Regulations.”
|Applicable Per MDCG 2021-25 (MDR) and 2022-8 (IVDR)||Description|
|13(2), second subparagraph||Where an importer considers or has reason to believe that a device is not in conformity with the requirements of this Regulation, it shall not place the device on the market until it has been brought into conformity and shall inform the manufacturer and the manufacturer’s authorised representative. Where the importer considers or has reason to believe that the device presents a serious risk or is a falsified device, it shall also inform the competent authority of the Member State in which the importer is established.|
|13(4)||Importers shall verify that the device is registered in the electronic system in accordance with Article 29. Importers shall add their details to the registration in accordance with Article 31.|
|13(6)||Importers shall keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.|
|13(7)||Importers who consider or have reason to believe that a device which they have placed on the market is not in conformity with this Regulation shall immediately inform the manufacturer and its authorised representative. Importers shall co-operate with the manufacturer, the manufacturer’s authorised representative and the competent authorities to ensure that the necessary corrective action to bring that device into conformity, to withdraw or recall it is taken. Where the device presents a serious risk, they shall also immediately inform the competent authorities of the Member States in which they made the device available and, if applicable, the notified body that issued a certificate in accordance with Article 56 for the device in question, giving details, in particular, of the non-compliance and of any corrective action taken.|
|13(8)||Importers who have received complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device which they have placed on the market shall immediately forward this information to the manufacturer and its authorised representative.|
|13(10)||Importers shall cooperate with competent authorities, at the latters’ request, on any action taken to eliminate or, if that is not possible, mitigate the risks posed by devices which they have placed on the market. Importers, upon request by a competent authority of the Member State in which the importer has its registered place of business, shall provide samples of the device free of charge or, where that is impracticable, grant access to the device.|