About EU Importer Services
These are the most common questions asked by our medical device and IVD clients. If you do not find the answer you are looking for, please feel free to contact us.
If an EU entity of the Legal Manufacturer will acts as the Importer, where will audits/inspections be held?
Inspections will take place at the registered place of the Importer. If the EU entity of the Legal Manufacturer will be the Importer, the address of that entity will be the location that will be inspected. MedEnvoy may be asked to be on site during those inspections.
Do manufacturers need to audit their EU Importer?
As an Economic Operator under the MDR the importer plays an important role in the manufacturer’s shipment activities into the EU. The Importer needs to have well developed processes in place to ensure they can execute on their role. If they do not have good processes in place and overall capability to act as the Importer, this could lead to challenges in the manufacturer’s supply chain and MDR compliance. It is for these reasons a manufacturer should consider the Importer to be critical to their MDR compliance in PMS, Vigilance and important chain to get their devices to the distributor or end user. As such it would warrant to audit the Importer. Whether this a desk top review of the Importer’s QMS or conduct on-site audits is up to the manufacturer.
Our European Authorized Representative (EC REP) is not part of the EAAR association? Is that an issue?
Not being a member of the EAAR (European Association of Authorised Representatives) does not in any way mean that your current EC REP is not a quality provider. We just would like to conduct a cursory review of your contract with your EC REP and confirm whether they have the ability and capability to provide the needed services expected from the EC REP. As your selected Importer on record, we can be held fully liable for your devices placed on the European market and as a result we need to make sure that our clients' devices are in compliance, including where agreed responsibilities between the EC REP and you as the Manufacturer are addressed and properly executed on.
Can we have MedEnvoy as the EU Economic Operator according to MDR Art.13 and also list someone else as the Importer of Record?
Yes. In fact we recommend using the ”EU Economic Operator according to MDR art. 13” wording in order to avoid being confused with the Importer of Record by customs.
Do System and Procedure Pack Producers (SPPP) have to register as actors in EUDAMED?
According to Article 29 (2) MDR, before placing a system or procedure pack on the market, the natural or legal person responsible (SPPP) has an obligation to assign a Basic UDI-DI to be provided to the UDI database, together with the other data referred to in Part B of Annex VI MDR.
What is a Single Registration Number (SRN) in EUDAMED?
The SRN number is the number by which your company will be identified in the EUDAMED database and all official regulatory documents in the EU. It is generated through the EUDAMED system after your registration there is validated by the relevant Competent Authority and (if applicable) your Authorized Representative. Read this in-dePth artricle about the EUDAMED SRN.
Do we need an importer for Northern Ireland?
Northern Ireland is part of the EU market. A manufacturer or importer established in the EU does not need to have an importer in NI (but does need a UKRP!). Vice versa a NI manufacturer or importer can place products on the EU market. He does not need to have an AR for this either.
From a complaint handling process, if the importer and EAR are two different parties, who would you advise to take charge of these complaints?
Both the EAR and the Importer have an obligation to forward complaints from the market to the manufacturer they represent. The most common process is that the EAR and Importer first forward the complaints to the manufacturer who will determine if the complaint is reportable or not. Another option is to give the EAR a written mandate to assess complaints and determine if the complaint is reportable before the manufacturer sees the complaint.
When in doubt or reportable, the manufacturer discusses and coordinates next steps with the EAR, who then takes action with regards to reporting and communication with the Competent Authority(ies).
What is the mandatory deadline for a device to comply with the UDI requirements?
The obligation for UDI assignment applies as from the date of application of the two new Regulations, i.e. 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices.
The obligation for submission of UDI data in the EUDAMED database applies from 26 November 2022 for medical devices and 26 November 2023 for in vitro diagnostic medical devices (provided that EUDAMED is fully functional before the date of application of the respective Regulation; otherwise, this obligation applies 24 months after EUDAMED has become fully functional)
However, manufacturers will be in a position to voluntarily comply with registration obligations as from 26 May 2021 for medical devices and 26 May 2022 for In Vitro diagnostic medical devices.
Do we need to translate our EU Declaration of Conformity?
Article 19(1) says: ‘The EU declaration of conformity … shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.’
This is a somewhat ambiguous piece of text. On the one hand it refers to the official language or languages of a Member State, on the other hand it also states that this must be required by that Member State. MedEnvoy takes the position that this is allowing a Member State to require the DoC to be translated. For as long as that is not the case, it seems that English can be used everywhere. We’ll monitor this going forward.
Where should we indicate our European Authorized Representative (EAR) in compliance with the EU MDR?
Under the previous Medical Devices Directive (MDD) the requirement was that the AR had to be listed on the label OR the IFU. The ‘new’ Medical Device Regulation (MDR) requires this for the label, but does not mention the IFU. Devices certified under the MDD may still have the AR listed on the IFU instead of the label, but MedEnvoy expects this will gradually change.
Important: It is allowed to add the AR to the IFU redundantly.
Do we need to translate the label and the IFU into the respective languages of the markets where we place the product? Are there any exceptions?
It is MedEnvoy's understanding that the labels and IFUs of your products need to be translated to the language(s) of the countries in which they are placed on the market, even if for professional use only. However, if your Authorized Representative or Notiifed Body explicitly has informed you that your current set-up (IFUs for professional use in English only, and the customer has to approve it is only in English) is acceptable, it is also acceptable for us. Please discuss this with your AR and/or NB. Read this article on translation requirements.
We have a legacy device. Are we exempt from the need to comply with importer requirements in Article 13 of the MDR?
The argument that (legacy) devices subject to an MDD certificate after 26 May 2021 are exempt from all provisions of the MDR expect Article 120 (3) MDR and the MDR provisions that this clause refers to does not hold up. Article 120 (3) MDR refers to these clauses to be applied in place of the corresponding clauses in the (AI)MDD, but does not state that it defers all other Articles of the MDR, since only Article 123 MDR contains the Articles of the MDR that are deferred.
Applying Article 120 (3) MDR as suggested would also lead to devices with identical appearance in the Union market, with some (MDR approved ones) subject to economic operator verification and others (MDD approved ones) not.
The interpretation that Articles 13 and 14 MDR apply to legacy devices is endorsed by several competent authorities and the Commission, and not contradicted by any authority.
Accordingly, it follows that as of 26 May 2021 Articles 13 and 14 MDR also apply for importers and distributors of legacy devices. Read this article for more details.
Do I need an importer, although I place only legacy products on the market for now?
The regulations do not stipulate or explicit state (yet) that a non-EU legal manufacturer needs to appoint an Importer, while a requirement for the legal manufacturer outside the EU to appoint an EAR is required. The regulation does indicate that a device is “placed on the market” and this can only be the responsibility of the legal manufacturer or, if a non-EU based legal manufacturer, the importer.
If a non-EU legal manufacturer markets devices in the EU and ships for example directly to end users, our current understanding is that the end-user cannot be the person or entity that can be responsible for placing on the market. Our legal scholars are indicating that if no formal Importer has been identified in the supply chain, that in this scenario possibly the EAR could be considered the Importer or potentially an involved 3PL. As we are all aware, 3PLs and EARs do not want to take on the role of Importer in any scenario. And when distributors are involved in the supply chain then they could become the defacto importer in the event there is no importer on record identified. Distributors as importers do come with numerous cons for the non-EU based legal manufacturer, in particular when you consider that the importer must be identified on the label or information that accompanies the device.
As a result, there are many nuances around the role of the Importer and who within the supply chain can be considered or becomes one if no Importer has been formally identified by the non-EU legal Manufacturer. If the non-EU legal manufacturer does not manage its supply chain in the EU, including the Economic Operators, they may face non-compliances from a MDD/MDR PMS perspective. The need for making a formal arrangement between the non-EU legal manufacturer and an entity (or entities) to take on the role of the importer is therefore not based on an explicit requirement in the MDR (or MDD) for the non-EU legal manufacturer to appoint an importer, but is driven by a need for the non-EU legal manufacturer to manage regulatory compliance in their supply chain that if not handled correctly by importers, EAR or distributors can directly have an impact on the compliance of the non-EU legal manufacturer.
Do manufacturers of ONLY legacy devices have to register as actors in EUDAMED?
Manufacturers of only legacy devices will have to register as actors in EUDAMED.
The obligation to register as actors in EUDAMED is applicable also to non-EU manufacturers and authorised representatives of only legacy devices.
Registered manufacturers and authorised representatives of only legacy devices are assigned an Actor ID that is not a SRN.
Our device has a valid MDD CE certificate. Do we need to comply?
Even if you hold a valid Medical Devices Directive (93/42/EEC) certificate that expires as late as 2024, and even if you don't make any changes to the product whatsoever, there are certain aspects of the MDR you must meet going forward from May 26, 2021. One of those is the need to appoint an EU importer. Read this in-depth article to learn why.
Legal & Liability
For which EU shipments is MedEnvoy considered the Importer?
As your importer, MedEnvoy verifies shipments based on information and documentation received from you. We can only assume importer responsibilities for those shipments where you have provided us with the required information. If you need to ship through different channels such as for example to a distributor that also operates as the Importer, MedEnvoy cannot be identified as Importer.
If a EU branch of the legal manufacturer takes on the role of importer, can the goods be shipped to distributors directly or must it be routed to the importer first?
The EU branch can act as the single Importer in the EU and be responsible for the Importer obligations as stated in Article 13 of the MDR while shipments go direct to distributors and/or end users.
For this, the EU branch must keep proof of shipment arrival at the distributor and needs to be able to show its shipment verification process. In addition, the EU branch needs to provide access to shipment records including verification in the event it is being inspected by Competent Authority of the country where the EU branch resides.
Please note: this answer is based on the assumption that inspection by the importer and placement of the importer label is done prior to goods physically entering EU.
If the manufacturer is based within the European Union, is it essential to update the contract with distributors to cover the obligations of manufacturer and distributor?
Although we are not providing legal counsel, we do recommend that you do update the contract with your distributors. Many of your distributors may not be aware of their MDR economic operator responsibilities and obligations and addressing these in the contract will help making them aware and prevent possible challenges down the road from a MDR compliance perspective.
Can an EU Authorized Representative have a contract in place with client only covering legacy MDD devices after May 26, 2021?
For the AR acting as a MDD/AIMDD AR after the date of application of the MDR means they are acting in non-compliance and they expose themselves, and thereby their clients, to their local competent authority.
Regarding risks for non-EU manufacturers: from a market surveillance perspective the manufacturer can only place devices on the market under the MDR after they mandated a MDR AR; they will have to stop placing devices on the market after May 26 until there is a MDR mandated AR.
In the case an EU entity of the Legal Manufacturer will be the Importer, what does this mean for the responsibilities and/or liabilities of MedEnvoy? How about audits/inspections?
MedEnvoy will provide a service that ensures that the EU entity of the Legal Manufacturer operating as Importer will be compliant. The service will need to be monitored accordingly. In case of neglect or misconduct, MedEnvoy might be held accountable.
Can you explain what you mean with 'responsible for defective devices'?
There is a liability exposure to the EAR for devices of the companies they represent as EAR and which were defective. This is a heavy load to carry for EAR since EARs have no influence or control over the manufacturing, packaging and labeling, shipping and placing the devices on the market, but nevertheless a defective device can be their problem.
This is also mentioned in MDR Article 11.5: “Without prejudice to paragraph 4 of this Article, where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer.”
Who is the Importer / Distributor when shipments are sent directly from a manufacturer located outside the EU to a hospital within the EU?
Nobody is considered the Importer / Distributor of a US company when shipments are direct to a hospital in the EU. Although this could possibly create issues down the road. The Legal Manufacturer must be sure that devices are not sold onwards by the end user in the EU. Also, EUDAMED will show which Legal Manufacturers operate on the Union market without listed Importers and/or Distributors. This might raise questions and create attention for those Legal Manufacturers from Competent Authorities.
What if we ship to an EU country and then export onward to another EU country?
Your devices will need to be cleared by customs for the European Union at the first point of entry. After that the EU allows the free movement of products, just as the US does between individual states.
What is meant by a “third country”?
A third country is not a member of the European Union or European Economic Area (EEA which includes 27 members of the EU plus Iceland, Liechtenstein and Norway). The EEA is where the MDR is in force and where there is currently a grace period for devices which have valid MDD / AIMD CE Certificates and can continue to sell their devices until their certificate expires and will be void after May 2024.
Does a non-EU based manufacturer shipping products directly to distributors in the EU still need an Importer?
A non-EU based manufacturer that ships products directly to distributors in the EU, needs to have an Importer. If the manufacturer has not selected an Importer, the distributors who receive the manufacturers products will in that scenario automatically become the Importer.
A non-EU based manufacturer can decide to select one of their distributors or each of their distributors to be an Importer as well. But distributors may not always be aware of the responsibilities and obligations that come with acting as the Importer. And if they do, they often do not want to take on the Importer responsibility. Another challenge doing it this way is that the non-EU manufacturer now needs to manage many different distributors who act as the Importer in the supply chain which will require each of them to have developed an efficient importing process and be identified on the label or information that accompanies the device. So much to manage with a chance that things do go wrong in the non-EU manufacturer’s supply chain and lead to MDR noncompliance.