The responsibilities of manufacturers that are based within the EU are straightforward, but for manufacturers based outside of the EU who sell on the EU market, it can be difficult to know which economic operator within their supply chain is responsible for what. In such cases, an Authorised Representative (AR) will play a part in ensuring a safe and legal production and trading process. As an AR is a term used within EU context, this blog will focus on this particular context only, leaving the role of an AR in UK context for our next blog.
What is an European Authorised Representative?
An European Authorised Representative (AR) is a legal party based within the European Union that acts as a liaison between a manufacturer outside of the EU and competent national authorities within the EU. They act on behalf of the manufacturer and ensure that the products being sold on the EU market comply with the European product compliance legislations. This concerns products that are sold either directly, via e-commerce (online), or through a fulfilment service provider.
The Regulations make it mandatory for the manufacturer and the AR to document the conditions of their partnership. This official and precise mandate should also list the tasks that the manufacturer will delegate to the AR. These tasks include, but are not limited to:
- Reviewing the CE marking
- Ensuring the availability of technical files
- Cooperating with market surveillance authorities
The Regulations also describe activities that cannot be delegated to an authorised representative, and that may not be part of the mandate between a manufacturer and an authorised representative. An AR should not be involved in verifying requirements related to the QMS (Quality Management System) for example, which remains an exclusive responsibility of the manufacturer.
The role of an AR
As established in the mandate, the manufacturer will thus outsource some of their tasks, meaning that the AR takes over some of the manufacturer’s responsibilities too, including:
- Ensuring the availability of technical documentation, among which the Declaration of Conformity, for national surveillance authorities and further cooperation with these parties
- Informing authorities when there is reason to believe that a product presents a risk and cooperate with these authorities to eliminate said risk
- Notifying the client of any duly reasoned request made by a competent authority with regards to the conformity of products
- In the event of any relevant dispute arising between Authorised Representative and a third party relating to the requirements of the Products, the AR shall notify the manufacturer of the dispute and shall attempt to resolve this dispute by providing all information, evidence, help and assistance which may be reasonably and/or mandatorily required.
For manufacturers of Medical Devices specifically, one more task has recently been added to the list: the AR should verify that manufacturers of Medical Devices register all the necessary information concerning their products in EUDAMED. This is in line with the most recent legislation (MDR/IVDR Article 11(3)(c)). A separate blogpost will be uploaded soon that will elaborate on the possible services of an AR for manufacturers of Medical Devices.
More tasks can be thought of, but these make up the very basics of what should be carried out if a manufacturer decides to appoint an AR.
Obligations when working with an AR
It must be said that having an AR is only mandatory for all manufacturers who want to trade their medical devices on the EU market, for manufacturers who want to trade other product groups on the EU market the manufactures are not obliged, but may appoint an AR. A European Economic Operator is required, but this could also be an importer or a Fulfilment Service Provider. There is an exception, however. Manufacturers who are based outside of the EU and whose products fall under the Machinery Directive must provide the name and the address of the party who compose the technical files on the Declaration of Conformity. If a manufacturer based outside of the EU chooses to appoint an AR, the AR can fulfil this role (composing the technical files) too.
Additionally, the Declaration of Conformity is not always marked with the AR’s address and signature. If the agreement between the manufacturer and the AR states that the AR’s details must be provided, this becomes mandatory. But it is not required for the AR to sign the Declaration, in which case it is the manufacturer’s details which need to be provided
Lastly, if an AR is officially commissioned, the aforementioned tasks that they can carry out, not only can but should be carried out by them from that point forward. The manufacturer has outsourced that part of their responsibility and should no longer execute these tasks themselves. The AR’s services can be extended beyond the previously mentioned list of tasks but should carry those out at the least.
Choosing the right AR
Appoint an AR prevents importers to have access to all of the manufacturer’s technical files, which includes documentation such as:
- CE test reports
- Instructions for use
- Design documents
- Declaration of Conformity (CE certificate)
For this, and multiple other reasons, having an AR is generally the preferred choice, seeing as this has the most advantages for the manufacturer. More information on the advantages of having an AR will be discussed in a separate blogpost soon.
So, since an AR will have access to all files and information of the production process and product, choosing the right one is very important. Appointing an AR that is not economically or commercially involved with products is logically a preferable choice for manufacturers. Similarly, it is crucial to choose an Authorised Representative that has expertise in compliance, considering the AR’s duties to verify the Declaration of Conformity and liaise between the manufacturer and market authorities. This will prevent legal complications and ensures that the manufacturer will only be notified of compliance matters that affect their product directly. A competent AR will be able to answer all question authorities can have and additionally advice you as the manufacturer accordingly.
If you are still looking for the right AR, click here to let us help you.
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