Placing a Medical Device in the European Union, Switzerland and United Kingdom region can be challenging nowadays. With Brexit, Swixit, and the issuance of the new legislation, this becomes a nightmare to organize.
So let’s review the situation and help you define your plan.
Table of Contents
What do you need to start with?
The most important is to first be clear with your marketing strategy. Which products do you want to sell to which region? I know that maybe your plan is to be able to sell everything everywhere but sometime this can become costly for no reason.
Why I am saying costly, is because if you are located outside of the region where you want to market your device you will need to appoint some Economic Operators to represent you.
Which Economic Operator do I need?
The problem with Brexit, Swixit is that before that you needed only 1 Authorized Representative and 1 Importer for the all region.
Now as all are separate, you will need 3 Authorized Representatives and 3 importers. I know this is making things complicated.
So you will need to find a representative and importer in the region where you want to sell your products. This company will represent you in front of authorities and help in case there are some issues. They have really strict responsibilities mentioned.
The identity of these companies should be clearly disclosed on your product and documentation. So this is not confidential information. I may say that only for the UK this is for now not mandatory.
Let’s review in more detail the situation in each country.
You want to sell in Europe?
Ok, let’s be more precise now. You are located outside of the European Union and you want to sell your products in the EU region.
So as mentioned before, you will need some support from EU companies that will help you do that.
But first, you will need to be compliant to the legislation in Europe and for that you will need to follow:
- For Medical Devices: EU MDR 2017/745
- For In-Vitro Diagnostic: EU IVDR 2017/746
What is great about the change in the regulation in Europe is the fact that the requirements for Economic Operators in EU MDR and IVDR are the same now.
Medical Device manufacturer responsibility
So prior to go to the EU market, the manufacturer needs first to check if they are compliant to the legislation.
For that I would advice to start with the EU MDR or EU IVDR article 10. This will provide you with all the requirements that should be fulfilled.
Why is it important? Because the economic operators that you will contact will need to check that. The Authorized Representative and Importer cannot accept your product in the EU if this is not compliant with the legislation.
So coming to them and asking them to take you as a customer can be challenging. Why? Because they are liable in case of an issue on the market.
What is liability?
I may let a lawyer explaining that to you but let’s try. Liability is mainly the fact that if something goes wrong with the medical device that was placed on the market, the economic operator is liable.
The main reason is the fact that they are your representative so they represent your company. Also because they accepted the products that are placed on the market and if there is an issue, they may need to justify their implication on it. They will also need to involve an insurance to then being able to get covered in case of a trial.
These elements are now carefully checked by these economic operators. This is why some of them will ask you to include them inside your liability insurance because they want you to cover any potential issue.
EU Authorized Representative support
The Authorized Representative in the EU is a company that has its place of business in the EU and that accepts your mandate to represent them.
This company should also have within its organization a PRRC which is a Person Responsible for Regulatory Compliance.
The Authorized Representative has clear and strict requirements to follow per article 11 of the EU MDR and IVDR.
1. Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.2. The designation shall constitute the authorised representative’s mandate, it shall be valid only when accepted in writing by the authorised representative and shall be effective at least for all devices of the same generic device group.3. The authorised representative shall perform the tasks specified in the mandate agreed between it and the manufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 51, at the disposal of competent authorities for the period referred to in Article 10(7);(c) comply with the registration obligations laid down in Article 28 and verify that the manufacturer has complied with the registration obligations laid down in Article 26;(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.4. The mandate referred to in paragraph 3 of this Article shall not delegate the manufacturer’s obligations laid down in Article 10(1), (2), (3), (4), (5), (6), (8), (9), (10) and (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.6. An authorised representative who terminates its mandate on the grounds referred to in point (h) of paragraph 3 shall immediately inform the competent authority of the Member State in which it is established and, where applicable, the notified body that was involved in the conformity assessment for the device of the termination of the mandate and the reasons therefor.7. Any reference in this Regulation to the competent authority of the Member State in which the manufacturer has its registered place of business shall be understood as a reference to the competent authority of the Member State in which the authorised representative, designated by a manufacturer referred to in paragraph 1, has its registered place of business.
So as said, a Manufacturer needs to be prepared to provide all this information to its authorized representative.
Symbol for the EU Authorized Representative
When an Authorised Representative is appointed by a Manufacturer, then its name and place of business should be mentioned on the product label.
There is an EC REP symbol that should be used. Behind it you will need to place the information of your Authorized Representative.
Read more on EU Authorized Representative
To go further in detail of the EU Authorized Representative role, we have also issued an article answering 11 questions about it.
Some people are thinking that the Authorized Representative is the only entity that is needed. You will also need an importer and here is the definition mentioned on the EU MDR and IVDR.
‘importer’ means any natural or legal person established within the Union that places a device from a third country on the Union market;
So if you are located outside of the European Union, the Importer will need to verify that your products are compliant with the legislation as per Article 13 of the EU MDR and IVDR.
Below is a copy-paste of the legislation. I put in red the part that oblige the importer to not place on the market a product that is not compliant to the legislation.
1. Importers shall place on the Union market only devices that are in conformity with this Regulation.
2. In order to place a device on the market, importers shall verify that:(a) the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;(b) a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;(c) the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;(d) where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
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.
3. 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.
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.
5. Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
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.
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.
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.
9. Importers shall, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
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.
What are the activities?
Each time the manufacturer is sending products to Europe, they will not be considered placed on the market until the Importer is releasing them to the next entity.
To understand the term placing on the market, you should have a look at the Blue Guide. This document is not specific for the Medical Device industry but to all the CE marked Products.
The main activity of the importer is to check that the product is complying to the regulation. They do that by verifying:
- that the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- that a manufacturer is identified and that an authorized representative has been designated by the manufacturer;
- that the device is labeled in accordance with this Regulation and accompanied by the required instructions for use;
- and where applicable, a UDI has been assigned by the manufacturer.
So this means that each product they will receive should be checked accordingly and proof of this check may be recorded for that in case of inspection by a Competent Authority.
When the product will then moves to the next entity which can be a distributor or a hospital, for example, this will then be considered as placed on the market.
A product still not released by the Importer is not considered as placed on the market.
What is an independent importer?
The importer is usually a company that is taking responsibility for a product and has also a warehouse.
Some historical importers are willing to take care of the logistic for the products but not for the regulatory part which was newly included in the EU MDR and IVDR. This is why a new kind of company has been setup which are the Independent importer.
This company located in Europe will be the importer for the products but will not see them or store them physically. This company will check all the elements written in the regulation but as a desktop audit. The manufacturer will need to send all the information per email, for example, and then the independent importer will review these data to confirm that all is compliant. The declaration of conformity, a copy of the labels, a review of the EUDAMED database, a review of the UDI information… All will be checked and then the independent importer will release the product to the Distributor (formerly the Importer).
So logistically there is no difference but the information will be reviewed by an additional actor.
Symbol for importer
One of the rules also defined in article 13 is the fact that the importer’s contact information should be placed on the product. This means that for an imported product you should have
- the Manufacturer’s name and address with the Black plant symbol
- the Authorized Representative’s name and address with the EC REP symbol
- The Importer name and address with the Importer symbol
Example of Labels
So know that you know all the symbols needed to place a device on the EU market. Let’s show to you an example.
You need to understand that if your company is located outside of the EU, there should be 3 symbols on your packaging.
- Legal Manufacturer
- Authorized Representative
With the name of each Economic Operator behind it.
EUDAMED is the new European Database for Medical Devices and this is the place where you have to register your company. If you are a Manufacturer, Authorized Representative, Importer, or System, and Procedure Pack provider, you will need to register your company.
After registration, you will receive your SRN number. This number is kind of an authorization for you to act as an economic operator in the European Union.
Manufacturers outside of Europe, will not be able to register to the database without having already an Authorized Representative appointed. The system as soon as you mention that you are coming from a country outside of the EU will ask you to select your Authorized Representative. So if you have none this will be difficult. This also means that your Authorized Representative should be registered in EUDAMED. If they are not you will not be able to register yourself.
Now, if your company act as a Manufacturer, Authorized Representative, and Importer, they will need to obtain 3 SRN numbers so which means 3 registration on the database.
Eudamed registration in 20 minutes
In this video, we explain to you how to register your company with the Economic Operator Module in EUDAMED. This didn’t go very well at the beginning but after sorting out the account creation then it was straightforward.
We can be your EU Authorized Representative and Importer
How to market your devices in Switzerland?
Switzerland is a specific case. Historically, the EU and Switzerland had a Mutual Recognition agreement under EU MDD/AIMDD/IVDD. But when there was the switch to MDR and IVDR, this Mutual Recognition agreement was not renewed. So this had a major consequence as Switzerland is now considered a third country and not part anymore of the European Union (Only for Medical Devices, not for other products).
So manufacturers that are located in Switzerland need now to appoint an Authorized Representative and an Importer within the EU. But this works also the other way around. Manufacturers located outside of Switzerland need to appoint an Authorized Representative and Importer located in Switzerland.
Legislation to follow
For Switzerland now you have 2 new legislations to follow:
- 812.213 Medical Devices Ordinance of 1 July 2020 (MedDO)
- 812.219 Ordinance of 26 May 2022 on In Vitro Diagnostic Medical Devices (IvDO)
But if you look carefully inside the texts, you will see that a lot of it is copying the EU MDR and IVDR or is directly mentioning it inside.
For example for the Authorized Representative, you need to look at article 51 and you can see inside this sentence:
The authorised representative’s rights and obligations and the scope of its mandate are governed by Article 11 EU-MDR.
So the text is not copying the rights and obligations from the EU MDR but directly mentions the article to follow that comes from the EU MDR. So you may understand that a lot of the elements you have to comply with are similar to EU MDR
Difference for Authorised Representative and Importer in Switzerland?
Yes there are differences even if the law is the same. The differences are in some important details. To help you understand the requirements, Swissmedic issued guidance (link).
First, the symbol to be used by the Authorized Representative is not the EC REP symbol but the CH-REP. You can find this symbol on the Swissmedic website.
The second difference is the registration in EUDAMED. Swissmedic is outside of the EU so there is no possibility to register in EUDAMED: Swissmedic is having another system in place where you request your registration to them and then obtain the CHRN number (Equivalent to SRN in EU). Swissmedic plans to create a SWISSDAMED database to imitate EUDAMED.
The third difference is in the rules between legacy devices and new devices. There are some dates or advice provided by Swissmedic on what to do for each of them and from which date. See below.
So this is pretty easy to register your devices in Switzerland if you already have CE marking.
WE CAN HELP YOU!!!
Do you need a Swiss Authorized Representative?
How to reach the UK market?
Since Brexit, the UK is not part anymore of the European Union. This is why you need now to appoint a UK Responsible Person and an Importer to continue distributing your devices in the UK. Ireland is excluded for this and remains an EU region. But this can still change.
UK Responsbile Person
The UK Responsible Person is similar to the EU Authorized Representative or the Swiss Authorized Representative. This is a company that is representing you in the UK.
The principle and responsibility are also common to the EU with some specificity. But the UK is excluding the EU MDR and IVDR and recognizes only the MDD, AIMDD, and IVDD. So this is maybe the major element to take into account.
The UK law is called the UK MDR 2002. And the responsibility of the UK Responsible Person under this regulation is the following:
- ensure that the declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer
- keep available a copy of the technical documentation, a copy of the declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements for inspection by the MHRA
- in response to a request from the MHRA, provide the MHRA with all the information and documentation necessary to demonstrate the conformity of a device
- where they have samples of the devices or access to the device, comply with any request from the MHRA to provide such samples or access to the device
- where they have neither samples of the device nor access to the device, communicate to the manufacturer any request from the MHRA to provide such samples or access, and communicate to the MHRA whether the manufacturer intends to comply with that request
- cooperate with the MHRA on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices
- immediately inform the manufacturer about complaints and reports from healthcare professionals, patients, and users about suspected incidents related to a device for which they have been appointed
- if the manufacturer acts contrary to its obligations under these Regulations:
- terminate the legal relationship with the manufacturer; and
- inform the MHRA and, if applicable, the relevant Approved Body of that termination.
Now when you read that and read the EU MDR article 11, you see a lot of similarities. This is why we can consider these roles identical.
One thing that is different is the fact that in the EU a Manufacturer can register his device by himself in EUDAMED or within a country whereas in the UK you cannot do that without the support of the UK Responsible Person. Only this company has access to the MHRA database and should populate all the information.
For more information on the UK rules for UK responsible person, here is the link that you should visit.
Symbol to be used
One thing that is strange is the fact that the UK government has not issued a symbol for the UK Responsible Person. So people actually write “UK Responsible Person” and then mention its name and address behind it.
This mention is even not mandatory for CE-marked products but only needed for UKCA products. As CE marking is authorized until mid-2024 so companies can still continue to distribute in the UK without changing their labeling.
See MHRA LINK
Learn More about UKCA
Adam Rae was my guest on the podcast and he shared with us the UKCA situation. So if you are still now aware of it please have a look.
Medical Device expert. Monir founded Easy Medical Device to help Medical Device companies to place compliant products on the market. He proposes his consulting services so don’t hesitate to contact him at firstname.lastname@example.org or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.