A distributor is defined as being 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 it into service.
The Regulations describe the roles and responsibilities of distributors in MDR/IVDR Article 14. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.)
Distributors should make sure, by representative sampling, that the devices they distribute are compliant with the obligations described in MDR/IVDR Article 14(2):
Distributors should verify that the devices have been CE marked, that an EU Declaration of Conformity has been drawn up, and that labels and instructions for use (MDR/IVDR Annex 1 section 23) are provided in the official languages of the Member States in which the device is made available (or in languages accepted by those Member States).
Distributors should also verify that the importer’s name is indicated on each device or in the accompanying documentation, and that the device bears a UDI.
Distributors shall ensure that storage and transport conditions, when under their responsibility, are appropriate and in line with the recommendations of the manufacturer.
If a distributor considers a device to be non-compliant with the regulations, the device shall not be made available on the market. In this case, the distributor should inform the other economic operators.
Distributors should inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health.
Distributors should also keep a register of complaints, non-conforming devices, recalls and withdrawals.
Distributors shall cooperate with authorities and make available all the documentation and information they have at their disposal.
Guidance
Guidance is also available from the Medical Device Coordination Group:
- MDCG-27 Rev1 Questions and Answers on Articles 13 (Importers) & 14 (Distributors).
- MDCG 2021-26 Q&A on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746.
Hello,
Could a company C based in Europe, that designed the product, be considered the Legal Manufacturer , even if the physical manufacturing is done by a 3rd party (contract in place…)? thanks
It can be whichever arrangement the two parties wish to have. However, because the role of legally responsible manufacturer comes with many obligations, it is essential to define which party is accountable for each of the manufacturer’s obligation and how the interactions are going to work. Ultimately there will be no doubt, because the name and address of the (one) legally responsible manufacturer will be printed on the device labels and instructions. But it is advisable to get this decision agreed early in the negotiations with your supplier.
1) Are the construction companies that supply medical devices as part of their construction contracts regarded as medical device distributors? 2) How about the lessor/owner of a hospital building equipped with fixed installations of medical devices such as gas delivery systems when the building is rented to the user? 3) Is a finance company that charges the end user for the use of the medical devices that they own regarded as distributor (i.e a leading company)?
In each case the answer will depend on who is the legal owner of the devices in question. If a company is only providing installation services, or providing finance, for the legal owner, they probably will not fulfil the definition of distributor. On the other hand, if the company owns the device, they probably will fulfil the definition of distributor.
Please read MDCG 2021-27 Rev.1 which includes the following clarifications: “Where a natural or legal person sources (via a legal transfer of ownership, possession or any other right, which does not necessarily require the physical handover of the product) devices from importers, distributors or manufacturers established in the Union and further distributes those devices to other entities (i.e. the operation of “making available” after “the first making available”), they are considered distributors.” Note that the operation of “making available” mentioned above includes “any supply of a device, other than an investigational device, 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.”
is a company that only distributes products from a manufacturer that is a company in the same multinational group considered the same as a distributor for MDR?
To clarify: the manufacturer(European) owns 100% a company that distributes in some EU states only the products of this manufacturer, in this case does art 14 apply ?
This question has been asked before. Therefore, I imagine that these companies are, in fact, autonomous legal entities with businesses registered in different countries, who are buying the devices from the manufacturer and selling them again. They are, in fact, companies in the supply chain and therefore they are distributors as defined in Article 2. Yes, Article 14 applies to these companies, but you might find that the obligations in Article 14 are no more than they already doing.
EU based vendor leases medical devices to EU based pharmaceutical company for the clinical trial purpose. medical devices are subsequently used by the hospitals, would vendor or pharmaceutical company be considered as the distributor? Thank you
According to the definition of “distributor” in Article 2 (34), any person in the supply chain, other than the manufacturer or importer, is a distributor. Therefore, in your scenario, both the leasing company and the pharmaceutical company are distributors.
If the devices are shipped directly from the EU based vendor (distributor) to the hospital for the purpose of the clinical trial managed by the pharmaceutical company, wouldn’t pharmaceutical company be the end user rather than the distributor? Pharmaceutical company is not physically or directly involved in the shipment of the devices.
In the EU MDR “User” is defined as being “any healthcare professional or lay person who uses a device”. It therefore seems unlikely a pharma company sponsoring a clinical trial would fit the definition of a “user”.
Wouldn’t in the scenario where pharmaceutical company rents medical device for the purpose of the trial run in the hospitals, pharmaceutical company be considered as the end user? The contract is between Pharmaceutical Company and the Vendor for the rental, not between the hospital and the Vendor.
At the end of the day, you have to decide. But consider the main obligations of distributors; to verify the device is in line with legislation and to ensure that complaints from users reach the manufacturer. Wouldn’t you agree that both the vendor (presumably purchase/owner) and the pharmaceutical company that specifies this device is used in the trial have those obligations?
We are a US OEM manufacturer who manufacturers a device for a private label who imports and distributes the product in the EU. A question has come up regarding complaint handling by this Private Label Distributor as they use a third party for all customer communications on their brand. Is there an article within the MDR that addresses responsibilities to forward complaint data to meet regulatory requirements?
Terms such as OEM manufacturer and private label distributor are not found in the EU MDR so they are not helpful in discussions about responsibilities under the EU MDR.
Primarily, there is the legally responsible manufacture of the device and that company is identified on the device label and in the instructions. That company has the obligation (Article 11.3) to have a system in place for recording and reporting of incidents and field safety corrective actions. Additionally, all distributors of medical devices in Europe have the general obligation (Article 14.5), if they which receive complaints related to a device they have supplied, to immediately forward that information to the manufacturer and, where applicable, the manufacturer’s authorised representative and importer.
If a company is designing products that are legally manufactured by a company outside the EU and then selling these products to distributors in the EU, are they a distributor, importer or both? The products never actually touch the company’s location as they ship directly to EU countries from outside the EU and transfer of ownership occurs outside EU.
What matters primarily is which company is identified on the device label and in the instructions as being the legally responsible manufacturer. It might be that the designing company has no role, as defined by the EU MDR, as the EU MDR only specifies the obligations of the legally responsible manufacture (identified on the label), as well as their authorised representative (in the EU) and importer(s) (in the EU) and any distributor(s) (in the EU).
We are a non-EU based distributor for a non-EU manufacturer. The manufacturer is currently contracted with an Authorized Representative and registered in EUDAMED. Under what circumstances, if any, would we be required to contract with an Authorized Representative and be registered in EUDAMED?
Thank You
As already stated in previous replies; it might be that your company has no role, as defined by the EU MDR, because the EU MDR only specifies the obligations of the legally responsible manufacture (identified on the label and in the instructions), as well as their authorised representative (in the EU) and their importer(s) (in the EU) as well as any distributor(s) (in the EU).
Hello,
Please can you assist with a question on our role – We are a UK manufacturer who also sells distributed product (not manufactured by us)
We are selling non EU manufactured medical devices into the EU, we do not sell direct to the end user but to a distributor within the EU who then sells into hospitals, what is our defined role in this process as per the MDR ?
Based on limited information:
a. Concerning the devices for which you are identified as the manufacturer, your initial distributor in the EU is an importer. You also need to appoint an authorised representative in the EU.
b. For the devices for which you act as an intermediary, you have no role under the EU MDR. The original manufacturer of the devices is exactly that, your initial distributor in the EU is an importer. The original manufacturer also needs to appoint an authorised representative in the EU.
We are a UK-based distributor of optical devices to hospitals and opticians. For our sales to Northern Ireland and the Republic of Ireland, would our customers, who are the end-users, also be considered as the importer? If so, do they have to register with EUDAMED as the importer of the device?
Article 2 (33) says: ‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market. Therefore, given that your customers are established within the Union and the UK is a third country, it seems likely that your customers in the Republic of Ireland fulfil the definition of importers.
There is also a guidance document: MDCG 2021-27 https://health.ec.europa.eu/document/download/82d9adbc-dbf0-40d4-93ed-ade673c8232a_en?filename=mdcg_2021-27_en.pdf
Who will be the distributor, when you offer a service (which falls under the MD regulation) via a website or an App Store?
The hosting provider? Any exclusions for SaMD?
Thanks
Suggest to read the recommendations contained in the “COCIR Impact Paper on the Medical Device Regulation” which includes “General Obligations of App Stores and Website Owners”.
Which EU Member States require a national registration of distributors?
Is it mandatory for distributor to report recalls done by manufacturer to competent authorities? If the manufacture has already reported it competent authorities.
No. You can read the obligations of distributors in Article 14.
Is it the responsibility of the importer to qualify/approve the distributor as such , for certain products? Or is the non-EU manufacturer who have these obligations? Could not directly find these issue in the MDR.
As you write, this question is not addressed directly in the EU MDR. However, according to Article 10, the manufacturer’s quality management system must address the selection and control of suppliers and sub-contractors. Of course, regardless of any contractual obligations toward the manufacturer, both importers and distributers have their own legal obligations as set out in Articles 13 and 14.
Hi,
This question is about the definition of “distributor’. A US company, serving as a vendor of the pharmaceutical Sponsor, purchased FDA approved medical device (e.g. blood pressure monitor for home health), and ships the devices to the company’s office in EU (under Sponsor’s “Importer of Record), and then distribute to EU Clinical sites who will distribute the device to participants in the clinical research (not research on the medical device, the device is just to collect blood pressure data to support the clinical trial). What would be the role of the US company and the EU Office of the US company? What would be the role of the Sponsor? Thank you so much!
Pharmaceuticals and devices are covered by different regulatory regimes. The US and EU also have different regulatory regimes. Therefore, you should seek the advice of an EU medical device regulatory professional. Based on your brief description; the US based Sponsor probably has no role at all under the EU MDR. The original device manufacturer is still the manufacturer, but presumably a non-EU manufacturer and therefore requires an authorised representative in the EU. The EU office is the Importer and, unless other offices are involved, also the distributor. The blood pressure monitors must also be CE marked.
If we sell a product from outside the EU to a Healthcare professional in the EU to use with their patient, is that Healthcare professional (hospital) considered a distributor under the EU MDR.
Given that a distributor is a person in the supply chain up to the point when the device is put into service, it seems unlikely a hospital would be a distributor. From your description it seems more likely the hospital is acting as an importer.
Dear Sir,
There is a national scandal in Hungary.
The interpretation of the Hungarian authorities extends the concept of “distributor” to the entire retail sector. According to their translation, all economic actors carrying out distribution are “distributors”: wholesalers, retailers, etc.
The authorities ask all pharmacies (retail stores) to register the whole list of currently sold (distributed) MD products. All professional arguments are rejected.
Is this a correct interpretation ?
In Your opinion, are retailers covered by the regulation?
Can you explain the difference between a distributor and a retailer?
Article 30, 2 says “Member States may maintain or introduce national provisions on registration of distributors of devices which have been made available on their territory.”
However, I draw your attention to the definitions of both distributor and putting into service. A distributor is one “that makes a device available on the market, up until the point of putting into service”. Whereas putting into service is defined as “the stage at which a device has been made available to the final user”. While Distributors are clearly entities in the supply chain. If a pharmacist is providing a device to a final user, he/she is putting the device into service and not acting as a distributor.
MDCG document 2021-27 – Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 – in the answer to question 5 provides a different interpretation.
“Can individual shops, community pharmacies, retailers, or other persons be considered distributors?
Yes. 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.”.
Additionally, your interpretation of putting in the service is not in line with the Blue Guide: “Putting into service takes place at the moment of first use within the Union by the end user for the purposes for which it was intended.”. The end user will put the device into service, and not his supplier.
Hello,
We are a US based distributor of medical device products which are manufactured in the EU (Germany). The products are transferred between the manufacturing site (Germany) and our third party logistics site (Germany) where they are warehoused and sent to customers in EU. Under MDR can this business relationship still exist, or must we/the distributor of products manufactured and sold in the EU also have an EU entity?
Many thanks
The EU MDR is addressed to those economic operators which can directly influence the quality and safety of medical devices on the EU/EEA market; the (legally responsible) manufacturer – as named on the label, as well as distributors within the EU/EEA supply chain. If your company is not one of those, the EU MDR is most likely not addressed to your company.
Hi,
If a company established in EU sell eyeglasses and contact lenses in their optic store to the final customer, he is a distributor or not according to the new legislation?
Thanks
Assuming the products in question are medical devices – you can check if they are CE marked and ask your supplier for the EU Declaration of Conformity. Yes, most likely your company is a distributer of medical devices which means the obligations of Article 14 apply to your company.
Are there any specific MRD related requirements for 3rd party service/maintenance providers. This could be the distributor who is also providing a maintenance/repair service to the medical device?
3rd party service/maintenance providers are not specifically mentioned in the EU MDR. However, depending on the scope of the service/maintenance business, the following Articles may be relevant; Article 2, (30) and (31), the definitions of “manufacturer” and “fully refurbishing”, as well as Article 23, Parts and components.
Our company outside of EU have obtained the MDR CE certificate and plan to sale the medical device product to EU Market. So we need to decide the target of consumer of EU. Can the hospital be our consumer and the hospital also is our importer? Or we must have importer and distributor in EU?
Any person or entity that is (based) established in the EU that receives the device directly from a non-EU manufacturer, will fulfil the definition of an importer whether they intend to or not.
Additionally, GS1 Healthcare GTIN Allocation Rules Standard states GTIN company prefix should reflect Primary Brand Owner, the brand most recognized by provider and/or patient. I can not find any guidance that requires Company Prefix to reflect the Legal Manufacturer. Its been an interesting but frustrating internal discussion. Looking to understand if MDR requires GTIN company prefix to reflect legal manufacturer. (Legal Manufacturer is otherwise identified appropriately all labeling) Thanks again.
The EU MDR mandates, for example, the regulatory requirements for a device’s labelling, or the regulatory obligations of those involved in device distribution. But it does not mandate, or regulate, common business practices such as branding or the use of GTINs.
It seems that in your business model you want the distributor to have a leading (commercial) role. However, from the perspective of the authors of the regulation, distributors only have a minor (regulatory) role. For this reason, you are unlikely to find your wished-for business practice in the EU MDR or in the guidance documents.
A US medical device company (ABC Medical) has a device OEM manufactured for them by another medical device company (XYZ Medical). XYZ Medical owns the design. The product is heavily branded ABC Medical, has an ABC Medical customer facing order number and is sold exclusively by ABC Medical. It is not available for sale through XYZ Medical. It is imported to ABC Medical’s EU warehouse from the US. It is sold direct and through distributors to end users depending on the EU country in which the product is sold. The package is labeled “Distributed by ABC Medical, Manufactured by XYZ Medical” The device is CE marked and EUMDR compliant.
Regarding GTIN number assigned to the device, which company should the Global Company Prefix reflect, ABC Medical or XYZ Medical? Will either option result in an EUMDR compliance issue?
Thank you
David
As long as the company (XYZ Medical or any other) is able to fulfil the obligations of the manufacturer (listed in Article 10), is registered in EUDAMED as the manufacturerand identified in the labelling as the manufacturer; what problems could there be? Who do you think might question it?
My RA group is saying Company Prefix MUST be Legal Manufacturer. I do not agree and can not find any guidance that support their position.
Hi,
If we distribute an device under MDR to another distributor, should we both place the symbol for distributor on the device?
The label and instructions are the responsibility of the manufacturer. You should discuss your question with the manufacturer.
Hello,
Would you please clarify if a healthcare professional or a device facility user (such as a hospital or a clinic) has any safety reporting obligation as per the new EU MDR?
Thank you.
Regards,
Aarav
Safety reporting by healthcare professionals is a matter regulated by the member states, i.e., through their national legislation. It is not a topic that is addressed by the EU MDR which applies to economic operators.
Dear Sir,
Kindly advise if the EU MDR regulations apply on distributors outside EU?
Is there any rule that commits, or obliges outside distributors to follow MDR?
What if article 14 , and 25 , or any other article for this matter, are somehow in conflict with local regulations in the distributor’s country.
If your company is established in a country outside the EU it is not considered by the EU MDR. The distributors referred to in Article 14 and elsewhere in the EU MDR, are distributors who are based in an EU country and are part of the supply chain operating within the EU.
By way of explanation; this is not only the case for medical devices but virtually all manufactured (non-food) products. If a company established outside the EU, supplies a product to a person within the EU (it can be an EU citizen or an EU company), the person inside the EU is (by definition) the importer of the product into the EU and is subject to the obligations of importers. Any person in the subsequent supply chain within the EU, apart from the final user, is (by definition) a distributor within the EU and subject to the obligations of distributors. But those obligations do not apply to companies such as yours who are outside the EU. You are subject to the laws of the country where you are established.
Hi, I would like to confirm this, as the “Distributor” definition does not specify that the Distributor must be within the EU to be considered.
Unlike the Importer definition, which explicitly states that the Importer must be within the EU, the Distributor definition does not. If that is the case, and the Distributor (outside the EU) is within the supply chain that gets CE marked product into the EU, would they have to meet EU MDR Distributor obligations as well?
No, that interpretation is not correct. The first person in the EU to receive a device from outside the EU is, by definition, the importer. Everyone else in the EU supply chain, after the importer, is a distributor. The supply chain mentioned in the EU MDR is the supply chain within the EU. A “distributor”, as described in the EU MDR, cannot be based outside the EU.
If the device is manufactured within the EU, is sent outside the EU to kit with a drug and then brought back into the EU (combination), is the party that brings the kit back into the EU an EU MDR Importer?
Since the device aspect was already manufactured within the EU, it was placed on the market first already within the EU prior to being placed in the kit. Thanks
The MDR does not specifically address this question: If the device is truly being first placed on the market, i.e., acquired by another EU entity who is not device manufacturer, then your argument may be valid that there is no importer. Nevertheless, the supplier of the combination is still distributing a medical device together with the medicinal product and must fulfil the obligations of a device distributor.