Economic Operators? I know that some of you are really asking themselves if you are working with some of them? You are also interested to understand what you should do with them? Are they critical to your business or to help you obtain your CE marking?
In this article, I will try to answer all these questions and help you become compliant within the European Medical Device Regulations (EU MDR and IVDR).
I will also include in this article the podcast episodes I released about Economic Operators. This will help you to have a better understanding of each situation.
In this article, I will try to brainstorm every question possible on the Economic Operators. I will also include some of the episodes I had recorded on my podcast. Let’s put some light on your darkness.
Who are the Economic Operators?
Yes, first thing first. Who are we talking about?
Let’s take the definition that is existing on the MDR and IVDR.
‘Economic Operator’ means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Article 22(1) and 22(3).
Ok, so it’s apparently clear. But not really. When we are reading a lot of articles about Economic Operator we mainly talk about:
- Manufacturer
- Authorised Representative
- Importer
- Distributor
But what is this person referred to in Article 22(1) and 22(3)?
If I am checking this article I discover that this is about “Systems and procedure packs”.
For 22(1) we have, an entity that combines devices that bear a CE mark with:
- other devices that bear the CE marking
- in vitro diagnostic medical devices bearing CE marking (EU IVDR 2017/746)
- Compliant products used within a Medical Procedure or which presence on the pack is justified…
So if your company performs such activity even if they are not manufacturing these devices are considered an Economic Operator.
For 22(3) we have, an entity who sterilizes systems or procedure packs with the purpose of placing them on the market.
Summary
We should consider Economic Operators:
- Manufacturer
- Authorised representative
- Importer
- Distributor
- Device combinators
- Steriliser company
But don’t say I said what I didn’t say. For the last 2 entities, these are entities that decide to do that by themselves and not asking permission to the original manufacturer.
Why?
Because they respect the requirements of these manufacturers.
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Who controls your Economic Operators?
This is really a question that a lot of importer or distributors are asking me. “Should I contact a Notified Body to sell Medical Devices in the EU market?”
The short answer is “No” but for some of the Economic Operators, they can still receive the visit of a Notified Body.
If you are an Economic Operator (except Manufacturer) located in France for example, the only entity that should control you is your Competent Authority which is ANSM for France.
Importer, Distributor, and Co.
If you are a Distributor or Importer, the Competent Authority of the country where you are based will have the responsibility to check that you are doing the right job. But don’t think that they will act similarly to a Notified Body.
A Notified Body, like TÜV SÜD or BSI, will audit you every year to check that you are still performing as required by the regulation. They can even perform an unannounced audit (Surprise, we are here…)
A Competent Authority does have the right to inspect you to check that you are complying with the regulation, but there is no frequency for that. Usually, they come to visit you only when they suspect a problem.
Let’s take an example: If you are not respecting the storage conditions for the products you are distributing and because of that there were some issues to the final user, then they can suspect that this comes from the distributor and will come to visit you.
All this is also applicable to the Procedure Pack producer or Sterilizer which are also considered as Economic Operators.
Authorized Representative
For an Authorized Representative, it can be also inspected by the Competent Authority. But, because there is a “but”, it can also be inspected by a Notified Body.
The Authorized Representative is representing some companies in Europe. So there is a special link to that. The contract between the Manufacturer and Authorized Representative clarifies the fact that there are some special needs like having a PRRC available, or storing files, sharing product data,… So if the Authorized Representative activities are in the scope of the QMS or the Regulatory Requirements of the Manufacturer, then the Notified Body can have a review of some of those elements. This can lead to an audit of this Authorized Representative.
Now, if this Authorized Representative does have many customers, then it can lead to many audit days so this should also be planned.
Here is an episode with Erik Vollebregt on this topic.
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Do the Economic Operators need a Quality Management System?
This is really a tough question, not because I don’t know the answer but because we can say yes and no.
Why “No”, because it’s not clearly mandatory if you are not acting as a Medical Device manufacturer. But I would say “Yes”, because even if this is not mandatory, you still need to organize your processes and your flow of information and a Quality Management System will help you for that.
In this episode with Erik Vollebregt, we are explaining the reason why we recommend you to have a Quality Management System but in certain circumstances, there is no specific need to certify it.
There are also some other circumstances where you should have one like if your economic operators are clearly part of the Quality Management System of the Multinational company that owns the Medical Device manufacturers. In that case, distribution is on the scope of your certification so no choice.
Check the below episode to get more examples.
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What should verify your Economic Operators?
With the EU MDR and EU IVDR, the Economic Operators do have some clear responsibility written in:
- Article 11: Authorized Representatives
- Article 13: General obligations of Importers
- Article 14: General obligation of distributors
- 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;
- 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 56, at the disposal of competent authorities for the period referred to in Article 10(8);
- Comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29;
- 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;
- 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;
- 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;
- 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;
- Terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation.
- The device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- A manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
- The device is labeled in accordance with this Regulation and accompanied by the required instructions for use;
- Where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
- The device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- The device is accompanied by the information to be supplied by the manufacturer in accordance with Article 10(11);
- For imported devices, the importer has complied with the requirements set out in Article 13(3);
- That, where applicable, a UDI has been assigned by the manufacturer.
If you want to get more information on Economic Operators’ responsibility, don’t miss the bonus episode made with Erik Vollebregt.
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Frequently Asked Questions
After having recorded all these episodes, I asked the audience if there are more questions that need to be answered. And there were a lot. So we created a LinkedIn Live with Erik Vollebregt where we talked all the questions and this is why I say that this article is really complete.
Impact of MDR and IVDR on Distributors
To complete all the discussion, here is the view of a Distributor regarding the impact of MDR and IVDR. This will show you some of the difficulty that they are experiencing.
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.
