Today, you’ll learn everything about the “European Authorized Representative for Medical Devices”
I planned 11 questions that everyone asked me regarding this entity. I tried to provide the best answer possible. So don’t hesitate to comment if you have some additional information you want me to clarify.
This FAQ will focus on the role of the Medical Device European Authorized Representative following the new Medical Device Regulation MDR 2017 745.
What you’ll learn today?
Today you’ll understand why it is really instrumental to choose the right European Authorized Representative to support solid business growth in Europe.
The relationship you will create is similar to getting married. It’s easy to give the ring but extremely difficult to get it back because it can cost you a lot.
I will go through 11 Frequently Asked Questions about the EC Rep or European Authorized Representative.
So if you don’t have already an Authorized Representative it’s important to apply all that you will learn today. I will go step-by-step so you’ll be really a Master on this topic.
If you already have one in Europe, then you should assess if he is the right one. You’ll understand why in a few minutes.
I am not saying that all that you’ll read here applies to everyone but to be honest it applied to the most. So please take actions and don’t just turn back thinking that it’s not important.
Below is a Video which summarize the role of a European Authorized Representative.
My Video: What is a European Authorised Representative?
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Table of content
- 1- What is a European Authorized Representative? (Definition)
- 2- Who needs a European Authorized Representative?
- 3- How to become an Authorized Representative?
- 4- What are the roles & responsibilities of a Medical Device Authorized Representative?
- 5- What are the result of not appointing an Authorized Representative?
- 6- Does your Authorized Representative name appear on your product?
- 7- Can my Authorized Representative get audited?
- 8- Can I change my Authorized Representative after I appoint one?
- 9- Why your distributor is not a good choice?
- 10- What if my Authorized Representative is in the United Kingdom? (Podcast)
- 11- How to select an Authorized Representative?
- Include KPIs to your Agreement (Podcast Episode)
- European Authorized Representative Powerpoint presentation - PPT (Bonus)
- Wrap up
1. What is a European Authorized Representative? (Definition)
If you look at the definition extracted from the new Medical Device Regulation 2017/745
‘Authorized Representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation;
LEARN MORE: Free Mini-Course MDR 2017/745
On the Regulation, an Authorized Representative, an importer, a distributor are also considered ‘Economic Operators’.
From my side, I would say ‘Economic Partners’ as they should be really close to your business and offer you the right support and service in exchange of a payment.
But don’t give to one of your Economic Partner all the keys. We’ll talk about that later with the question – Why you should not choose your Distributor as your Authorized Representative?
So to summaries, this partner should be in the European Economic Area (EEA), European Union (EU) & European Free Trade Association (EFTA) – See on next paragraph all the countries). As we are talking specifically about this region it makes sense.
However, don’t rush yourself to choose anyone. Be patient, I will also give you some tips on how to choose it later.
2. Who needs a European Authorized Representative?
From the definition above you can imagine that if you are in a country of the European Union, you don’t need an Authorized Representative. You can already start a business without any problem if you are complying to the CE marking regulation.
Only companies that are located outside the European Union and who wants to sell Medical Devices inside European Union need to appoint an Authorized Representative to be their legal Representative.
Countries that don't need an EU Authorized Representative
To be more specific here is the list of countries that don’t need an Authorized Representative to sell Medical Devices in Europe. They are part of 3 groups:
- EU: European Union
- EEA: European Economic Area
- EFTA: European Free Trade Association
EU
France, Germany, Netherlands, Belgium, Luxembourg, Italy, (United Kingdom), Denmark, Ireland, Greece, Portugal, Spain, Austria, Sweden, Finland, Hungary, Poland, Slovenia, Slovakia, Czech Republic, Estonia, Lithuania, Latvia, Malta, Cyprus, Romania, Bulgaria, Croatia
EEA
Norway, Iceland, Liechtenstein
EFTA
Switzerland
The Authorized Representative will have to fulfill tasks defined on Article 11(3) of the regulation.
- First of all, he must accept your mandate in writing.
- He shall at least be representing the same generic device group.
So if you have many generic device groups, you can choose many Authorized Representative.
A Generic Device Group
You should understand this as a category of products that are similar. If you are selling wheelchairs so all the wheelchairs are part of a generic group. But if you sell pacemakers and orthopedic implants, this is 2 different generic devices.
To simplify this grouping, we use the GMDN codes (Global Medical Device Nomenclature). I find a PDF for you so you can understand better how you can do this grouping. LINK
EC Rep for Clinical Investigation products
Even if you are not selling your products on the European Union for the moment, as soon as you’ll need to execute some clinical investigation on this territory, you’ll have to appoint an Authorized Representative.
So don’t choose a quick one only because it’s to support you on the Clinical Investigation. Take your time to find the right one.
3. How to become an Authorized Representative?
It can be really seductive to become an Authorized Representative of a company and offer the service. You are maybe an expert on Medical Devices and want to start your own business. Helping other companies to grow their business can be really challenging.
So let’s see if you are able to comply on the definition of a European Authorized Representative.
What are the requirements to be a representative?
To become an EU Authorized Representative of a company there are 2 main obligations:
- Being a natural or legal person established in the European Economic Area (EEA), European Union (EU) & European Free Trade Association (EFTA)
- You should be explicitly designated (Authorized) by a non-European manufacturer with a written mandate
- And most importantly you should accept to be the Representative of this company.
So it looks easy. Anyone can do it apparently.
But before you accept this role, please understand that you should comply with a lot of rules.
In Europe, you will be legally considered as the main representative for the manufacturer. So if the manufacturer act fraudulently, you can be judged responsible if you are not alerting the Competent Authorities.
To show more credibility, we recommend you to already have some experience in the Medical Device Quality & Regulatory field. At least, if I am a manufacturer looking for such a Partner, I would not choose a newbie.
Your reputation in this business is really important. So a recommendation for you is to keep learning and stay up-to-date with the regulation so you can really support your Partner.
Can I be my own EU Authorised Representative?
This question is really interesting. And my answer is Yes.
If for example your company is based in China and opens an office in Germany. The German office can be your Authorized Representative.
To be honest this would be the best scenario with only one condition.
You need to have a Regulatory Compliance person at this office. The objective is not only to have a European address but also to perform all the tasks of an Authorized Representative.
You need to have a PRRC
One thing that has changed between MDD and MDR is the fact that now you need to have a PRRC within your European Authorized Representative. I have also created an article about that. Click here.
In short, this is a person that will guarantee that all the activities done by the EU Authorized Representative are compliant with the regulation.
An EU Authorized Representative is liable in case there is an issue on the market, so you should be sure that all your activities are good to be on the safe side.
As usually, an EU Authorized Representative is a small structure, they can hire a consultant to be the PRRC for their organization.
If you need the support of a PRRC for your organization, don’t hesitate to contact EASY MEDICAL DEVICE.
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4. What are the roles & responsibilities of a Medical Device Authorized Representative?
First of all, the European Authorized Representative must do the tasks you defined on the agreement you signed together. The service that they offer is not voluntary. You are paying for that.
What is important is the fact that this written mandate can be requested by the Competent Authorities so it should be available at any time. The content can be inspected and the minimum requirements should be listed. Below is the list of activities that should be normally done by your PRRC.
The EU Authorized Representative responsibilities are :
1. Documentation check
- Verify the Declaration of Conformity
- Review the Technical Documentation
- Check where applicable that an appropriate conformity assessment exist
- Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years and for implantable devices, it’s 15 years)
If the Authorized Representative has multiple clients, his Record Retention and Document control procedure should be clear. This is to be sure that he is not losing all the information or providing the wrong version of some documents.
2. Registration check
- Verify that the manufacturer is complying with the registration of the Unique Device Identification according to article 27
- Make sure that the registration of the device is performed according to article 29
- Also that the registration of the manufacturer, Authorized Representative and importers are done according to article 31
3. Audit Support
- In case requested by the competent authorities, the Authorized Representative should give all the information and documentation necessary to prove the conformity of a device, in an official language
- Keep the manufacturer informed of any request coming from the competent authorities.
- Verify that the competent authorities receive the samples or is given access to the device
- Cooperate with the competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by devices
4. Vigilance report
- Immediately tell the manufacturer about complaints and reports from healthcare professionals, patients and users related to suspected incidents performed by their device.
This can be something important to precisely write on the agreement. Check the last chapter on KPIs
5. Compliance
- Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation
Be careful to not break the law!
To clarify the responsibilities of the manufacturer or the company, I have to tell you that the written mandate signed with the Authorized Representative does not delegate the manufacturer’s obligation written on article 10.
In case the manufacturer is not complying with article 10, the Authorized Representative is legally liable for defective devices on the same level as the manufacturer.
Administrative tasks
One activity the manufacturer can delegate to his Authorized Representative is for the specific national notification requirements.
If he is based in France, he can be required by you to act on your behalf as a service for some administrative action in the country.
On each member state, there are some national laws and someone should execute them. Important is that it should be clearly described in the agreement.
In case the Authorized Representative is terminating his mandate with the manufacturer. He should tell the Competent Authorities and if applicable the Notified Body that issued the certification. And he should also mention the reason for this termination.
Is it the same for the In-Vitro Diagnostic Medical Device Manufacturers (2017/746)?
For manufacturers of In-Vitro Diagnostic Medical Device, they should also appoint a European Authorized Representative.
If you look at the regulation 2017/746 article 11, you can see that the main requirements are similar. There are some differences related to the specificity of the devices.
5. What are the result of not appointing an Authorized Representative?
As the Medical Device Regulation state it, you need for sure to appoint an Authorized Representative if you want to sell your product in Europe.
If you don’t,
- I assume that your Notified Body will not issue your EC Certificate which is kind of mandatory to legally market your medical device.
- If you still try to send your products to Europe, I bet that someone will stop it at the border.
Why does this matter?
Because there is no Marketing Authorization issued by the Competent Authorities for your product.
All this is in place to protect patients against counterfeit products and cut the risk of injury.
6. Does your Authorized Representative name appear on your product?
Yes, anyone using your product should know who is your Authorized Representative. There is a special logo for that. See below
Behind this logo, you should write all the information related to your Authorized Representative.
His name, address and contact number should be on your labeling, packaging, and Instruction for Uses (IFU) behind this logo. In case of a complaint, he is immediately informed of any customer issues or reports issued by a healthcare professional, user or patient.
If it doesn’t appear, this can also be an alert at the border. If your place of business is outside EU and that you don’t mention an Authorized Representative on your products you can be in trouble.
One important risk having your Authorized Representative detail on your product is when you want to change him. In that case, it can cost you a lot of money and time.
Here is the deal:
Because you’ll have to:
- change all your labeling, packaging and Instruction for Uses.
- tell the competent authorities and your Notified Body.
- change marketing material
So you really need to take care of choosing a solid Authorized Representative for your business. Someone that will not close after a few years and someone who will really give you some expertise for what you should do in the region.
That’s not all…
I can tell you also that your Notified Body is also appearing on your labeling (The number under or behind the CE mark is the ID number of your notified body) but only if your product is underclass:
- I with a measuring function or delivered sterile or re-processed to be re-used
- IIa
- IIb
- III
So if you decide to change your Notified Body, it’s the same story.
Learn more on the new Medical Device classification Link: New EU Medical Device Classification
7. Can my Authorized Representative get audited?
Yes! The Authorized Representative is equal to the manufacturer for the Competent Authorities. So an audit is something they should be ready for.
All mandatory documentation should be available at the headquarter of the Authorized Representative. This is important as these document should be presented to the Competent Authorities upon request.
As mentioned before, a good Document Retention procedure is important. As you visit your Authorized Representative, take the time to test this by asking him to show you these documents. You can then verify if they have the right version.
We can say that this is an unannounced audit “lol”.
But out of all this, the question you should ask yourself is: Is he ready for that?
Do you have some confidence that he can work for you? You should be sure of that as your business is at risk.
8. Can I change my Authorized Representative after I appoint one?
Yes, a European Authorized Representative of a company can be changed. It will be like a divorce.
On Article 13 of the Medical Device Regulation 2017/745, you learn how to change your Authorized Representative.
First of all, this change should appear in the agreement between the manufacturer and the Authorized Representative (Outgoing and incoming).
Compliance aspects
To be compliant, the manufacturer should address the following aspects:
- The date of termination of the outgoing Authorized Representative and the date of start of the incoming one.
- The date until which the manufacturer can show the outgoing one on the information or promotional material
- The transfer of documents, including confidentiality aspects and property rights
- The obligation to the outgoing Authorized Representative to send to the manufacturer or incoming Authorized Representative, any complaints or reports from healthcare professionals and patients or users about suspected incidents related to the device for which it has been designated.
Expensive choice
I know I repeat myself, but remember that changing your Authorized Representative will be really expensive. So you will need to try to follow the advice that is coming on the next chapters so select him.
9. Why your distributor is not a good choice?
By understanding the interest of an Authorized Representative and the one of a Distributor I would say that it’s pretty dangerous to appoint a Distributor as your representative for European Union.
Let’s list the main reason.
Your Authorized Representative of a company should be independent and neutral.
This even when it comes to judging that another distributor will be of the best interest of the manufacturer
The Authorized Representative should be aware of any problem that happens with your product on the market.
He will be your key partner and should also handle some confidential information.
But he will also have to make decisions that can go against the interest of the Distributor which then can be beneficial for you.
The Distributor on those cases will not be neutral and will push on his direction.
In the case there are a lot of complaints about a good selling product, the Distributor can try to lower the risk so you don’t go for a voluntary field action.
When at the same time, a qualified Authorized Representative, will define all the regulatory aspects and take the right decision as he has no financial interest when you sell more or fewer products.
Your Authorized Representative should have a copy of your technical documentation. So he will be informed about all the secrets of this product.
The Competent Authorities may ask him to give that as quick as possible for its review but as it is not a professional regulatory agency, the record retention and change control of those documents can be a problem.
As this can happen with all the European Union member states, you need to have a professional that has the ability to give the right information and data at the right time.
The European Authorized Representative of a company should have enough skill on Regulatory Compliance to be able to give you the same service as a lawyer. He should defend your interest in front of authorities.
He will have to assess that your product is complying to the regulations and that you respected all the rules.
To put you and himself on the safe side, he will have to check if the classification you identified is correct. This can be challenging if you make a mistake to this one.
On one side, it’s on its interest that the manufacturer respects the rules. When on the other side a Distributor can decide to take the risk knowing that they can sell a lot more products.
For manufacturers, that are really new to the EU Regulation, it can also be important that the Authorized Representative of your company is supporting you on the CE Marking process to obtain the CE Certification and the ISO Certification. So this skill is really a “Must”.
My conclusion is: Regulatory Compliance is not a specialty for the distributors.
As you know, the name of the Authorized Representative is on the label of the product. The distributor knows that and for him, it’s free advertisement.
But if there is a conflict with your distributor because of a fee increase or anything else, it will cost you a lot of money to change all the labeling material.
Your distributor can also use this as an argument to put pressure on you to accept some changes. He will start with a small fee increase. Then can go to a bigger one… But you are stuck. This small increase will cost you less than to fully change all your labeling material.
The best model for you
So now you will ask me what is the best model for you. Below is a schematic of it.
The best model for you is to define:
- An Importer/Distributor on one side to take care of your products
- An Authorized Representative on the other side to take care of the compliance of your company
I hope this helps you to see how it is a bad idea to appoint your Distributor as your Authorized Representative. I am sure there are good distributors but I would prefer to protect my business than to bet on this.
10. What if my Authorized Representative is in the United Kingdom?
As you may know, United Kingdom submitted on March 29th, 2017 the notification of its intention to withdraw from the Union Pursuant to Article 50 of the Treaty on European Union. See the page related to that on the European Commission Website.
So it means that, from March 30th, 2019 the United Kingdom will then become a ‘third country’.
Today, the result for a manufacturer who mandates an Authorized Representative in the United Kingdom is really critical.
Why !!!
Because the UK is going out of the European Union. Look at the definition of an Authorized Representative. He needs to have his place of business in the EU.
The manufacturers will then lose their certificate unless they act now to change it to a new one.
As mentioned earlier, the financial consequence can be important. The change of it means also a change in the labeling.
What applies to the Authorized Representative is also applicable to the Notified Body. So don’t choose one that is in the UK.
So if you are on this situation act now before you put your business at risk.
Do you need a Notified Body for your CE Mark? Check the class of your product to define that: FREE FORM AVAILABLE
Podcast episode on Brexit
On Episode 13 of the Medical Device made Easy Podcast, I invited Richard Young from Sensus Group to help us understand what to do during the Brexit situation. His advise are critical to survive during this period.
11. How to select an Authorized Representative?
The most important thing to select your Authorized Representative is to follow a simple procedure.
Here’s the deal:
I created a 5 step process that is guiding you from the beginning to the signature of the agreement. When you’ll read it you’ll find it simple as you can compare that to 2 peoples that look for the right partner in life.
It’s cool to use real-life techniques to succeed in business. But nothing is guaranteed at 100%.
There is the first step where you are looking for the right one. So you investigate anything you can find and assess if there could be a good match. I never used it but I think you can compare that to TINDER.
Here you approach the right candidate and see if there is a feeling. If you are not asking yourself why you did contact it.
You need to see the candidates that you selected. You need to talk to them. At the extreme, if you cannot have a face to face the least is to organize a Skype or something so you can see if there is a good visual match.
Normally, you should also visit its offices. If you cannot, during the Skype meeting, ask if they can show you on camera.
During this face to face you’ll need to ask more question to the candidate to understand if he is really doing what he says he’s doing. And also that what he can do match with what you need. It’s also important to see the cost of their service.
Ok! Now that all if fine, we can write the papers and sign them. You should really write all the requirements that each party should follow.
I am sure I forgot some other tips but if you respect those, there is no reason to make a mistake.
To help you, I created a checklist that summaries some of the tips I provided you from this article. If you follow the 5 steps, you should be good to go.
I will also include an EU Authorized Representative list I did find with their contact detail. One of the famous ones I already been in contact with is Emergo.
Free Download
Free Package with checklist and list of European Authorized Representative
You are still not done after you signed the agreement. As discussed, you then have to start working on your labeling material and maybe create some promotional material. But all the registration steps with the competent authorities are also important.
You should maybe include in your agreement a support for CE marking or Vigilance reporting. But this really depends if you have the knowledge in-house or not.
Ultimate tip: If you are looking for an Association for European Authorized Representative, I did find the EAARMED.
This stands for European Association of Authorized Representatives for Medical Devices. Maybe they would help in case of more questions when you want to choose your European Authorized Representative.
European Authorized Representative services
I can be your EU Authorized Representative
You are looking for a European Authorized Representative
Contact me
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Include KPIs to your Agreement
Something that could be important when you choose your Authorized Representative is to start some Key Performance Indicators (KPIs).
For example, he has the obligation to tell you of any complaint. If you want really to satisfy your customers, you should be aware of that as soon as possible.
The Authorized Representative should not take his time to send you back this information. You can for that include that in written in the agreement.
Example: Within 2 business days, You should receive the complaint. This can also give you some sign if he is efficient. If you receive that after 1 week every time, then maybe a discussion will need to happen.
KPIs are also something that can help you to negotiate the agreement, the cost of the service. You are waiting for a certain standard for the service you pay for, so try to have some factual data that you can show and not only feeling.
Learn more about KPIs on Episode 7 of the Medical Device made Easy Podcast.
Podcast Episode 7 webpage: https://podcast.easymedicaldevice.com/7
European Authorized Representative Powerpoint presentation (PPT)
I prepared for you a Powerpoint presentation so you can get a summary of this article. This presentation was uploaded on Slideshare.
Wrap up
You understand from the definition that the Authorized Representative is really a critical partner for your success. His name is on your product and he is liable for any law that you have to follow.
Your choice can make your business grow or shrink. With the new information related to the UK BREXIT, it’s even possible to impact your business if your Economic Partner is located there.
This EU Partner can also be instrumental to help you for your CE Marking and defend your interest in case of a conflict in terms of regulation.
His responsibilities are key so don’t neglect any detail. You can even hire a consultant to help you test if he his skilled enough to support.
I hope this helped you to make the right decision and to understand the role of an important Economic Partner. Don’t forget to download the different material I ready for you so you can be ready for this challenge.
Please give me your comment. I am really interested to see if this topic was interesting to you and if there is an aspect that was missing. I promise to answer to you.
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 info@easymedicaldevice.com or +41799036836
My objective is to share my knowledge and experience with the community of people working in the Medical Device field.
