If you are as a seller in Amazon, it is likely that you're familiar with this language, since, throughout the year 2023, the different marketplaces have been asking for this requirement is gradually after the entry into force of the rule.
The relevance of the Authorized Agent emerges in the context of the Regulation of the Market Monitoring (EU) 2019/1020, especially for those companies situated beyond the limits of the European Union that entered into the market specific products targeted at consumers within the market of the union, articles 4 and 5 of that regulation underscore the imperative need of having an authorized representative, especially for products that require the CE mark.
From a pragmatic perspective, this implies that the entities foreign disbursed funds to organisations or european players to assume the role of authorised representatives. In addition, it is vital that both the bottle and the label clearly show the name and the location of the authorized representative, together with the iconic symbol that can be seen on the packaging of EC REP.
In the following lines, we will explore some key considerations to keep in mind in relation to the authorised representative.
The background of the authorized representative in the EU
The guidelines set out by the Directives 93/42/EEC and 2007/47/EC already dealt with the figure of the Authorised Representative, European, emphasizing the need for the Manufacturer to appoint this representative. However, the transformation was complete with the introduction of the European Regulation 2017/745. In fact, the obligations and requirements of the Authorized Representative are described in detail in the article 11 of the MDR (EU) 2017/745, establishing a control function products more active and substantial than in the past.
In particular, the Authorized Representative European takes on the task of checking the conformity of the products marketed with the requirements of the new regulatory framework. In addition, you must interact with the Competent Authorities in Europe, the Manufacturer in non-eu citizen and Importers, especially in surveillance and control activities.
Also, it has a direct responsibility in case of damage caused by defective products, which implies that both the Manufacturer in non-eu citizen and the Authorized Representative are directly responsible in situations of lack of safety or efficacy with physical damage to the patient, the operator or to third parties.
This is clearly set out in paragraph 5 of article 11, which establishes the liability of the Authorised Representative before the law for defective products under the same conditions as the Manufacturer.
What are the implications of being an authorized representative in the EU?
Representing foreign entities that market their products to consumers in the European Union, the authorized representative plays a fundamental role. This key actor must be a legal entity duly registered in an EU member state and is subject to various responsibilities as stipulated in the regulatory framework.
Documentary Evaluation: The main task is to guarantee the adequate preparation of the EU declaration of conformity and the technical file.
Records Management: It is imperative to comply with the obligation to maintain detailed records and documentation related to the product. Such records must be available to market surveillance authorities during the period specified by legislation. Likewise, it must be ensured that technical documentation can be provided to these authorities when they request it.
Labeling Compliance: The responsibility is assumed to verify the conformity of the labels and markings, ensuring that they comply with the legislation applicable to each product. Product Testing Guarantee: Verification that product testing meets the requirements established by EU legislation is essential in the work of the authorized representative.
Solidarity liability of the authorized person responsible
Without a doubt, one of the most important implications of the Authorized Representative is joint and several liability. According to the regulatory framework in the European Union, the Authorized Representative shares joint and several liability with the manufacturer in relation to the products marketed. This means that both the manufacturer and the Authorized Representative share the burden and responsibility in case of problems or defects in the products.
Joint and several liability implies that both parties can be held jointly responsible before the authorities and before the law in situations involving regulatory non-compliance, defective products or any other problem that affects compliance with applicable regulations. It is crucial that both the manufacturer and the Authorized Representative comply with all legal obligations and requirements to ensure product conformity and mitigate any risks associated with marketing products in the European Union.
Communication with market surveillance authorities
The authorized representative must provide the national market surveillance authorities with all information and documentation necessary to demonstrate compliance. This includes test reports, risk assessment, product labels and packaging labels.
Furthermore, if there is reason to believe that a product poses a risk, market surveillance authorities must be informed. The EU Representative requests and verifies the seller's documentation to support the conformity of its products. Additionally, it communicates with national market surveillance authorities in the event of measures against products due to compliance issues.
Do I need to have an authorized representative?
If your company is outside the EU and you sell products within the scope of one or more EU directives that require CE marking, an Authorized Representative is required. This designation is crucial and required to ensure compliance with European regulations.
The Regulation takes a non-exhaustive approach by not providing a specific list of affected products. Instead, it applies to particular regulations that encompass products within defined categories. Examples of these covered categories include, but are not limited to, construction products, personal protective equipment, and gas appliances. This strategy allows for a broader and more adaptable application of the regulation, addressing various sectors and products within a specific and precise regulatory framework.
Based on the above, it can be determined that any economic operator, whether manufacturers, importers or suppliers, as long as they are not established in the European Union and their products are affected by the CE marking and the directives to that effect, must have an authorized representative. in the European Union.
If your company is based in the European Union, you do not need an Authorized Representative, since you are already directly assuming responsibility for the products you import, for which you have already declared conformity.
If you have any questions about what is discussed in the article or about any regulatory compliance process for your product, contact us.
