An importer is defined as being any natural or legal person established in the EU that places a device from a third country on the EU market.
MDR/IVDR Article 13 describes many of the general obligations of importers. (For more information see also: ‘Blue Guide’ on the implementation of EU product rules.)
The importer is responsible for making sure that the devices they place on the market bear the CE marking, are accompanied by the required information and labelled in accordance with the Regulation, and have been assigned a UDI where applicable.
In addition, the importer should verify that devices are registered in EUDAMED.
If an importer considers that a device is not compliant with the Regulations, the device shall not be placed on the market and the importer shall inform the manufacturer and the authorised representative. The importer should also inform the authorities if they suspect that a device has been falsified or that there is a serious risk to health.
Importers should make sure that storage and transport conditions, when under their responsibility, do not jeopardise compliance.
Importers shall indicate on the device or its packaging, or in a document accompanying the device, their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted.
Importers also have the responsibility to inform manufacturers and their authorised representatives in the event of complaints. They should also keep a register of complaints, non-conforming devices, recalls and withdrawals, and escalate non-compliance to authorities if they suspect that a device has been falsified or that there is a serious risk to health.
Importers are also required to cooperate with authorities and provide samples or grant access to the devices.
Guidance
The Medical Device Coordination Group (MDCG) has endorsed the following guidance documents (this is not a complete list):
Hi.
I was wondering how an importer should find that a medical device has been approved by MDR.
Thank you very much
You can search the EUDAMED database for devices at https://ec.europa.eu/tools/eudamed/#/screen/search-device
Hi,
regarding the notification of complaints, it is always mandatory to inform also the Authorised Representative or can I just notify the manufacturer?
You should inform both. According to Article 13, 8., on receiving complaints, importers shall immediately forward this information to the manufacturer and its authorised representative.
Hi,
How can submit my application? What’s the requirements(Documents required)? and how long would it take to approve?
As an importer you register your company details in the “Actor registration module” of the EUDAMED database.
There is a web-page dedicated to helping you register https://ec.europa.eu/health/md_eudamed/actors_registration_en
On that page you will find various documents and video demonstrations explaining the registration process, including;
Actor registration request process
Demo actor registration module
Can importer and Authorize Representative be the same company?
The EUMDR does not address this question. You must decide if the company is able fulfil the obligations of both Article 11 and Article 13 or not.
Clause 3.2 of the latest Blue Guide (https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=OJ:C:2022:247:FULL&from=EN) will clarify your question.
is custom-made medical device importer and manufacturer need to register in EYDAMED?
Yes. Please read answers 2 and 3 in the guidance document MDCG 2021-13 Rev 1 Questions and answers on obligations and related rules for the registration in EUDAMED of actors other than manufacturers, authorised representatives and importers.
The hospital in EU can be identified as end-user, so can the hospital be a importer at the same time?
Yes, a hospital in the EU can be an importer. But before you decide your supply model it might be advisable to check if the hospital concerned is willing to fulfil the obligations of an importer in Article 13.
Dear EUMDR
As importer, we have recieved an updated technical manual from the manufacturer. Should we, as importer, assure that the updated technical manual is of no concern from the EU-Authorized Representative?
If you fulfil the obligations in Article 13 there is no need to do any more.
Thankyou for your response. A follow-up question;
By approving the manufacturer as an economic operator in our Quality Management System and the information given from the manufacturer, do we need to see any kind of proof that the EU-authorized representant has accepted their roles as such for the concerned devices?
Thankyou in advance
As you write, this is a question about your quality management system not about the regulation. As modern quality management systems tend to be risk based. What is the risk to your stakeholders if you haven’t seen such a proof?
Can we have just one Importer name indicated on packaging, and send the goods into Europe to different location? Example our Importer address is in Belgium who takes all the obligation in Art 13, but we have direct containers to multiple countries such as Spain, Germany, etc. Are we expected to appoint multiple importers for the different destination in Europe. Or are we expected to ask our Belgium importer to do all the clearance for all different ports in Europe? We would like each distributors in each country to do their own clearance of goods ,but importer name will indicate only the Belgium company. Please advise.
Maybe you are mixing the importer with the authorised representative. As Manufacturer, you must ensure the name and address of the (sole/single) EU authorised representative is on the device label, but not the importer’s details. As you write, there can be multiple importers of a device and therefore it is the importer’s obligation to ensure their details accompany the device in their particular supply chain.
importer also needs to get MDR CE if importer wants to put his own logo/trademark on devices and packaging ?
OR MDR CE is just for manufacturers ?
It depends how much the importer changes the product. Please read Article 16 “Cases in which obligations of manufacturers apply to importers, distributors or other persons.”
where can I get a list of European Importers from?
As there are more that 5,000 importers registered in EUDAMED you will need to be specific. Perhaps start by choosing one country and speak to the Embassy trade department. Or contact an EU trade consultant.
Is an importer required if you have an authorized representative
If there is an importer in the EU, by definition the manufacturer must be from outside the EU and therefore must appoint an authorised representative within the EU. An importer is, by definition, inside the EU and therefore does not/cannot do it.
Can my Authorized Rep also act as my Importer? Or are the two roles filled by two separate individuals? Also, who is responsible for assigning an Importer – Manufacturer outside EU or Authorized Rep inside EU?
Yes, nothing in the MDR prevents an authorised representative from also acting as an importer. Keep in mind that although a device can only have one authorised representative, it is not the same for importers. A device can have several importers, for example in different EU countries.
I would like to import our new product, disposable syringe to France . May i ask you to check its suitability for Europe . I am importer and same time i am the distributor . As i write EU REP , should i mention myself as importer ? Or it is enough to keep the word DISTRIBUTOR ?
Or i can write DISTRIBUTOR & IMPORTER
I attached the BOX.
The device labelling must show the name of the manufacturer and if applicable the authorised representative. Those two are the mandatory minimum. Importers can be mentioned on the label but as it’s not mandatory, options should be discussed with the manufacturer. As a device can have several importers it is sufficient if the importer is mentioned in a document which accompanies the product in the supply chain. It is also not required to mention the distributor on the label so again, it should be discussed with the manufacturer.
The Legal Manufacturer is located in UK and its European Authorized Representative (EU REP) in an EU country.
The medical devices are sold by the EU REP to the distributors located also in EU countries. I would like to ask you if the distributors are considered as importers?
If the ownership of the devices is transferred from the UK manufacturer to the authorised representative based in the EU, then the company in the EU is likely both authorised representative and importer. Any distributors within the EU buying from the importer are simply that, distributors.
I would like to notify a product to EU countries that need to be notified. (ex Spain, Portugal…)
Basically, we already have CE MDR.
Here, I have questions.
1. Does the importer or distributor have to do notification? or Can manufacturer who is not established in the Union do this?
2. If we have multiple distributors for Spain and AA distributor already notified the product to Spain authority. Can BB distributor sell the product without going through the notification process?
Thank you!
The manufacturer registers in EUDAMED both their company details, as an economic operator (See Article 31), and their devices’ details (See Article 29). If the manufacturer is an EU based company that is the all.
If the manufacturer is based outside the EU then its authorised representative and its importer(s) must also register their company details as “economic operators” in EUDAMED.
Some individual EU member states additionally require distributors of medical devices to register in a national database, but this is not described in the EU MDR. You must consult the national health authority whether this is a requirement of that country.
I would like to check notification process for EU Countries.
In case of having multiple importer or distributor, although the device already notified to the applicable authorities, do other importers or distributor notify the device as well? or If already have notification, can others sell the product?
Manufacturers register their devices in EUDAMED (see Article 29). Whereas Authorised Representatives and Importers register their companies as “economic operators” in EUDAMED (see Article 31). Once the device has been imported into the Union, any other company in the distribution chain (ie. buying and selling) must comply with the requirements of a Distributor (see Article 14). However, the number of distributors is not restricted.
We have a class I self-certified device approved under MDR. Is it mandatory to have an importer for that? Do we need to include this information also in our technical files or labels?
Assuming you are representing a manufacturer outside the European Union, anyone who is based within the European Union and buys your device will, by definition, become an importer of that device into the European Union. As such, you don’t really appoint your importer(s), they take that decision by agreeing to import your products.
MDR states: “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established.” May we kindly ask you to specify some examples of acceptable accompanying documents. Can an invoice or delivery note be considered as acceptable accompanying documents?
There is a guidance MDCG 2021-27 which states “The importer may choose the appropriate accompanying documentation, as long as it reaches the end user.” Will an invoice or delivery note reach the end user? Examples given in the guidance include “a sticker affixed to the label or a leaflet.”
See https://health.ec.europa.eu/document/download/82d9adbc-dbf0-40d4-93ed-ade673c8232a_en?filename=mdcg_2021-27_en.pdf
Case Study: The Legal Manufacturer is based in the UK, however their device is manufactured, released and dispatched from a supplier in the EU direct to the end user. Sales are managed from the UK via their e-commerce website.
Given the physical product originates in the EU, does the UK Legal Manufacturer need an Importer under the EU MDR?
Regardless, consider the address of the manufacturer in the labelling and instructions and you will probably have your answer. If the manufacturer’s address is in the UK, there must also be an Authorised Representative. If there needs to be an Authorised Representative in the Union it follows there will also be an importer in the Union.
Hi,
want to apply for import permit license for medical device in EU market from overseas. Could anyone help me with what documents required and which import permit application please?????? also my company already have CE marking certificate.
thank you.
The MDR states in Article 13 (3) that “Importers shall indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.”
Is it therefore sufficient to show the name and address of the importer or is it mandatory to show the role of the importer with a symbol according to ISO 15223-1 or the indication “importer”?
Harmonised symbols are developed to provide an alternative to making multiple translations. So it likely depends whether the importer is importing the device only for a single language territory, or for wider distribution to users with different languages. As MDCG 2021-27 makes clear, the document which indicates the importer’s name and address must reach the end user, and by implication be understandable by the end user.
Is it mandatory for medical manufacturers to report their imports? Is that data publicly available?
Both manufacturers and importers are required to register in the EUDAMED database, together with their common devices. Therefore, if you know the name of company, you can search in EUDAMED for their importers and which devices they import.
Hi,
We are located in Austria and plan to buy examination gloves from a Chinese company that is registered in EUDAMED database, the product itself has also been imported to EU market before. But we want to add our company name and logo on the primary packaging when the Chinese factory finishes the production in China. The Chinese company is still shown on the primary packaging as manufacturer.
If we sell the gloves in EU market, we will be the importer since the product has new label?
If we don’t sell the gloves in EU market, we don’t need to follow the MDR regulation?
Thank you for your support and help 🙂
Concerning branding: As long as the legally responsible manufacturer is still shown on the label and in the instructions, the compliance of the device is unlikely to be affected by a change of branding. However, the manufacturer should always confirm this with the notified body that approves their labelling.
Concerning compliance: The wording used in the EU MDR is “makes a device available on the market”, so it doesn’t matter if a medical device is sold or given for free, it must still comply with the EU MDR.
Regarding individual medical device and importer:
I would like to know if I, as a legal manufacturer outside EU, sign an agreement with an importer.
Question 1: Should detailed individual product list or just product tpye be indicated in the agreement? Or, the importer of individual product can be found in EUDAMED.
Question 2: MDCG 2021-27 says that there shall be no multiple importers for one same individual device. If a distributor wants to by an individual product from the legal manufacturer, should the distributor buy the product from the manufacturer or the importer or both?
Concerning question 1: This question is not addressed by the EU MDR. It is a matter to be decided between the manufacturer and the importer. Regardless, the imported medical devices must be registered in EUDAMED along with the manufacturer, the importer, and the authorised representative.
Concerning question 2: Your statement is not correct. According to MDCG 2021-27 question 4. There can be multiple importers of a device model/type. There is no restriction made by the EU MDR. It is a matter to be decided between the manufacturer and its importer(s).
We plan to sell medical items under our own brand, but the products are designed and/or manufactured by someone else outside of the EU. Are we considered an importer or manufacturer if we only sell medical items on e-commerce platforms? Also, as an importer, is it required to have a Quality Management Systems (QMS)? Thank you.
You asked “Is the CE mark mandatory for importers and distributors in EU countries to import and sell my products?” Yes. Importers and distributors must check the devices they intend to import or distribute in the European market are CE marked.
You asked “Can importers and distributors get it?” No. The Manufacturer is responsible for compliance.
I am a medical device manufacturer and my products are not CE marked. Is the CE mark mandatory for importers and distributors in EU countries to import and sell my products? If yes, who should register the CE mark? Can importers and distributors get it? Or can only products with a CE mark be imported?
Hello, one of our customer imports CE certified products with Class 2B and Class 3 “medical device” status produced outside Turkey and distributes them on the market in Turkey.
The relevant product is currently offered to the Turkish market in accordance with the “ANNEX II TECHNICAL DOCUMENTATION” section 2 of the “REGULATION (EU) 2017/745” regulation, with a bilingual label in English and also with the necessary Turkish information within the scope of local legislation.
However, the importer company, which is our customer, wants to offer the products to the Turkish market with labels only in Turkish within the scope of “MDR – language requirements for manufacturers (January 2024)”.
https://health.ec.europa.eu/system/files/2024-01/md_sector_lang-req-table-mdr.pdf
Within the scope of “MDR – language requirements for manufacturers (January 2024)”; Is it possible to obtain approval by submitting apostilled Turkish label & packaging samples translated by a sworn translator to the Notified Body, and in this way, to place the products on the market in Turkey with only Turkish labels?
Thank you.
Best regards,
Your question about the procedure to be followed should be addressed to the notified body involved. However, given that the EU MDR does not specify individual language(s) – it requires only those languages determined by the Member State in which the device is made available to the user or patient – it is difficult to imagine any grounds on which the notified body could refuse.