1. Authorised Representatives can be referred to in different ways
The legal entity that is designated to represent non-EU manufacturers in the European Union is formally called a European Authorised Representative. However, this party can be referred to in different ways, including:
- EC REP
- EU Responsible Person
The terminology used to describe AR services often depends on the product category and related legislation. For example, the commonly used term for medical devices is EC REP.
Regardless of the product category or how such a legal body is called, the main function of an AR remains the same: an Authorised Representative verifies the CE marking of products and registers as an EU point of contact so that businesses gain access to the European market.
2. More businesses will soon require an Authorised Representative
All non-EU companies require an AR to sell their products in the European Union. Since the United Kingdom is no longer a part of the EU, all producers based in the UK must now choose a European Authorised Representative to continue selling their products in the EU (read more about Brexit and how we can help here).
Furthermore, the Market Surveillance Regulation, which will come into force in July 2021, will affect which businesses must have an AR. The new regulation will increase controls to ensure that all products sold into the European Union have an official EU representative to verify compliance and cooperate with national authorities.
While the new regulation will have the greatest effects on e-commerce, these strengthened controls apply to all businesses selling their products in the European Union. The best way for all non-EU businesses to prepare for the Market Surveillance Regulation is to register with an Authorised Representative now.
3. An AR does not carry out the CE marking process, but verifies it
Even when a business is located outside of the European Union, CE marking is the obligation of the manufacturer. This means that it is the manufacturer’s responsibility to ensure that their product complies with all relevant EU Directives by carrying out the necessary testing, compiling a technical file and applying the CE mark.*
An AR does not certify products, but they review the technical file provided by the manufacturer and evaluate the safety of a product by checking that the CE marking process has been completely and correctly carried out.
*In some cases, (such as with certain medical devices), the AR can carry out additional steps for the manufacturer such as performing conformity assessments. If you have questions or need assistance with the CE marking process, contact us.
4. Authorised Representative services continue after CE marking verification
After evaluating the certification procedures and confirming the safety of a product, the Authorised Representative registers as the official EU point of contact. At this point, the AR acts as a liaison between the non-EU manufacturer and the European national authorities. The address and contact information of the AR must also be provided on the product and its packaging.
As the EU point of contact, the Authorised Representative has several important responsibilities on behalf of the manufacturer. These include:
- Ensuring the availability of technical documentation
- Cooperating with market surveillance authorities
- Informing authorities when there is reason to believe that a product presents a risk
5. Choosing an AR is an important part of the process
Considering the responsibilities of the Authorised Representative, it is important to choose your AR wisely. Your Authorised Representative will have access to all files and information of the concerned product(s), so appointing a party that is not economically or commercially involved with products is a preferred choice for manufacturers.
Given the AR’s duties to verify the Declaration of Conformity and liaise between the manufacturer and market authorities, it is crucial to choose an Authorised Representative that has expertise in compliance. Choosing an AR with sufficient knowledge of legal frameworks and regulatory changes prevents legal complications and ensures that you, as the manufacturer, will only be notified of compliance matters that affect your product directly.
Are you an exporter or e-commerce seller based outside of the European Union? Choose AR Experts as your Authorised Representative. Powered by Certification Experts, AR Experts offers:
- 25+ years of experience
- Technical and legal knowledge of CE marking
- Fast, flexible and customer focused service
To learn more about AR experts, click here.