Comprehensive Guide on European Authorised Representatives and the new Market Surveillance Regulation

We have created a full Authorised Representative guide for you to help you ensure that you have an in-depth understanding of the new regulation and what it means for your business. We will take you through an overview of what an Authorised Representative is, when you need an Authorised Representative, and how you can appoint one successfully and easily. We will also explain the new Regulation and what this means for your business.

What is an Authorised Representative?

If your business is based outside of the European Union, you need an authorised representative to verify that your product is legally allowed to bear the CE mark. An Authorised Representative does this by checking the technical file of a product. This includes specifications, CE test reports, instructions for use, design documents, and a Declaration (CE certificate) of Conformity.

What are the key duties of an Authorised Representative?

Authorised Representatives act as a representative based in the EU and represent a business on all communications, legislation, documentation, and certification matters. Below are 10 key responsibilities of an Authorised Representative:

• Registering the product with the National Competent Authorities (NCAs) before they are marketed
• Acting as a primary contact point for all NCAs
• Maintaining a current copy of all technical files, available for inspection by NCAs
• Including their name, address and contact details listed on the packaging and associated materials of the product
• Being responsible to Incident and Field Safety Corrective Action (FSCA) reporting to NCAs, in corporation with distributors
• Advising of any changes to relevant laws that will impact the marketability of the product
• If a member state seeks to withdraw the product from the market, the EU Authorised Representative will represent the company to the European Commission
• Maintaining reports concerning the critical evaluation of all data collected during evaluations for review by NCAs
• Notifying or are notified by NCAs if there are serious product incidents or FSCA
• Carrying out any post-market surveillance that is necessary

What important documents and files do they authorise and take care of?

Authorised Representatives verify that your product is legally allowed to bear the European CE mark by checking the technical file of a product, including:

• Specifications
• CE test reports
• Instructions for use
• Design documents
• Declaration (CE certificate) of Conformity

What kinds of products require an Authorised Representative?

Authorised Representatives are required for many products on the EU market including:

• Aerosol dispensers
• Agricultural and forestry vehicles
• Aircrafts
• Appliances burning gaseous fuels
• Batteries and accumulators
• Biocidal products
• Bottles used as measuring containers
• Cableway installations
• Chemicals
• Construction products
• Cosmetics
• Crystal Glass
• Detergents
• Electronic products
• Energy-related products (falling under Directive 2009/125/EC)
• Equipment for use outdoors emitting noise
• Explosives
• Fertilisers
• Fluorinated greenhouse gases
• Footwear
• Hot-water boilers fired with liquid or gaseous fuels
• Hydrogen-powered motor vehicles
• In vitro diagnostic medical devices
• Lifts and safety components for lifts
• Machinery
• Marine equipment
• Measuring instruments, such as most beverage glasses, pints etc.
• Medical devices
• Motor vehicles, trailers and systems
• Non-automatic weighing instruments
• Personal protective equipment, such as sunglasses, gloves, and face masks
• Packaging and packaging waste
• Petrol and diesel fuels
• Pressure equipment
• Products containing mercury
• Pyrotechnic articles, such as fireworks
• Radio equipment
• Recreational craft and personal watercraft
• Simple pressure vessels
• Textile products
• Tobacco products
• Toys
• Tyres

What is an economic operator?

The term ‘economic operator’ refers to any natural or legal person who is legally obligated in relation to the manufacturing or distribution of products, in accordance with the relevant European Union harmonisation legislation.

What is a Manufacturer?

A manufacturer refers to any natural or legal person who designs or manufactures a product with the intention of making the finished product available for use under their name. The manufacturer is who trademarks the product and uses its brand to market the product.

Manufacturers should always ensure the design of their products meets the requirements set out in applicable directives. They are also responsible for ensuring that the correct technical documentation is provided and kept for the required period. The product should be marked with their name and address, and they should ensure that suitable information and instructions are provided with the product.

What is an Importer?

An importer refers to any natural or legal person with a base in the EU who places a product from a non-European country into the EU market.

Importers should always ensure that any CE-marked product is compliant with the CE marking requirements of the European Union. They should identify themselves as the importer and provide their name and address on the product, packaging, and instructions for use. The language of the instructions for use should be suited to any of the end-users. They are also responsible for keeping copies of the Declaration of Conformity for at least 10 years after the last date on which the product was sold and should respond to any requests for information from MSA.

What is a Distributor?

A Distributor refers to any natural or legal person in the supply chain who helps to make the product available in the EU market.

A Distributor should ensure that the product bears the CE marking and that it is accompanied by the required documents and instructions for use in a language that can easily be understood by consumers and other end-users. They should always ensure the goods are identified with model, serial, and batch identification numbers. They should check that the name and address of the manufacturer (or Authorised Representative) are clearly marked and visible on the product. They should also inform the manufacturer or importer if the goods are unsafe and take necessary steps to ensure that the product conforms to the applicable requirements.

What is a Fulfilment Service Provider?

A Fulfilment Service Provider offers end-to-end solutions. They store products on warehouse shelves, pack them, address them and deliver them to customers. No matter whether fulfilment for online shops or for companies that sell their goods via wholesale or foreign trade – with the commissioning of a specialised service provider and a tailor-made service portfolio, they primarily relieve themselves of a lot of work. This enables them to concentrate fully on the company’s core competencies. The providers’ comprehensive range of tasks includes numerous activities, for example:

• Warehousing
• Acceptance of orders
• Order picking
• Article master data maintenance
• Packaging of goods and products
• Franking of consignments
• Shipping to the end customer
• Returns management

What do ‘harmonised standards’ mean?

Harmonised Standards refer to the standards the EU holds for certain things, such as product compliance, which relate to the goal of the EU to achieve uniformity in the laws of its member states.

What is CE Marking?

CE Marking is the manufacturer’s declaration that the product meets EU requirements for health and safety. All products requiring the CE mark also require an Authorised Representative.

What is a Conformity Assessment?

A manufacturer can only place a product on the EU market when it meets all the applicable requirements. The conformity assessment procedure is carried out before the product can be sold. The European Commission’s main objective is to help ensure that unsafe or otherwise non-compliant products do not find their way to the EU market.

How does it work?

• The conformity of a product is assessed before it is placed on the market
• It needs to demonstrate that all legislative requirements are met
• It includes testing, inspection and certification
• The procedure for each product is specified in the applicable product legislation

What are the objectives of the Conformity Assessment procedure?

• To demonstrate that a product being placed on the market complies with all legislative requirements.
• The procedure should ensure confidence of consumers, public authorities and manufacturers regarding the conformity of products.

How does it work in practice?

• Product legislation describes the conformity assessment procedures for each product.
• Manufacturers may choose between different conformity assessment procedures, if applicable.
• The assessment is carried out by the manufacturer. If the applicable legislation requires it, a conformity assessment body is involved in the conformity assessment process.
• Conformity assessment is complementary to market surveillance. Both procedures help ensure the smooth functioning of the internal market.

What is a Declaration of Conformity?

As part of conformity assessment, the manufacturer or the Authorised Representative must draw up a Declaration of Conformity (DoC). The declaration should contain all information to identify:

• the product
• the legislation according to which it is issued
• the manufacturer or the authorised representative
• the notified body if applicable
• a reference to harmonised standards or other normative documents, where appropriate

Why do I need an Authorised Representative?

Authorised Representatives are important as they keep the European marketplace safe and consistent. They ensure that the standards of products are adhered to and oversee the legal components of a product’s safety.

When do I need an Authorised Representative?

According to Regulation (EU) 2019/1020, companies without any presence or an address in the EU who are selling products to EU customers must have a European Authorised Representative. When there is an agreement signed between an Authorised Representative and a manufacturer, the manufacturer can, and must, use the legal name and address of the Authorised Representative on the product’s packaging.

It’s important to note that the obligation to have an AR is exclusive to manufacturers of Medical Devices. While it’s not mandatory for manufacturers dealing with other product categories to appoint an AR, they have the option to do so if they wish. According to the EU Market Surveillance Regulation (MSR), a European Economic Operator is necessary, and this role can be fulfilled by an importer or a Fulfillment Service Provider. Understanding these distinctions is vital for manufacturers navigating the regulatory landscape of the EU market.

How to know if you need an Authorised Representative? Perhaps some of these common scenarios will help

Q. I am an e-commerce operator selling products globally, do I need an Authorised Representative?

As of 16th July 2021, if you are importing your products to the EU and you do not have a physical presence in the EU, then the answer is yes. You should follow the same procedure as regular product manufacturers to obtain an Authorised Representative.

Q.I am a UK (or other non-EU) manufacturer of products that fall under the General Product Safety Regulations (GPSR). I have EU distributors. Do I need an Authorised Representative?

If your EU distributors and retailers are prepared to take on the obligations of the producer then the answer is no. These obligations include checking the safety of the product, marking their name and address on it, and dealing with consumer protection authorities. If they cannot take on these obligations or you do not want to use them as your importer then you must appoint an AR E-commerce platforms are likely to demand from you to appoint an AR, as the new GPSD states that they are responsible for potential hazards as well, and appointing an authorised representative would relieve them from these obligations. 

Q. I am an EU (or other non-UK) manufacturer of products that fall under the General Product Safety Directive (GPSD). I have UK distributors. Do I need an Authorised Representative?

If your UK distributors and retailers are prepared to take on the obligations of the producer then the answer is no. These obligations include checking the safety of the product, marking their name and address on it, and dealing with consumer protection authorities. If they cannot take on these obligations or you do not want to use them as your importer then you must appoint an AR.

Who can be an Authorised Representative?

To become an Authorised Representative of a non-EU company, you need to fulfil the following obligations:

When accepting the role of an Authorised Representative, keep in mind that if the manufacturer acts fraudulently, you may be held responsible unless you alert the competent market authorities. Also, you must have a Regulatory Compliance person working for you who is familiar with the EU legislation and the EAR’s duties.

What would happen if an Authorised Representative wasn’t appointed?

If an Authorised Representative is required and not appointed, the products are illegal to be sold to EU consumers. It is a risk that is best not to be taken and one that can cause many issues for your products. If market authorities discover that you do not have an EU Authorised Representative, the product will be recalled. Furthermore, if the Authorised Representative details aren’t clearly visible on the packaging, they will often be destroyed upon arrival.

Can the Authorised Representative be changed once appointed?

Yes, the Authorised Representative can be changed however, it is not an easy process. The change is required to appear in the agreement between the manufacturer and the Authorised Representative (outgoing and incoming). In order to ensure compliance, the manufacturer should ensure they address the following aspects:

• The date of termination of the Authorised Representative and the date of the start of the new one
• The date up until which the manufacturer can display the departed Authorised Representative on the information or promotional material
• The transfer of documents, including confidentiality aspects and property rights
• The obligation of the departing Authorised Representative to send any complaints or reports to the new Authorised Representative about any incidents relating to the product

What are the obligations of an Authorised Representative once the contract has ended?

When the contract of an Authorised Representative has ended, it is very likely that there will still be products on the market that have been granted access to the market while the old Authorised Representative was still under contract. This means that even though the old Authorised Representative is not under contract anymore, they will most likely still be contacted for certain matters. In these cases, the old Authorised Representative will most likely forward those matters to either the manufacturer or the current Authorised Representative.

When the contract of one Authorised Representative ends and issues come up with the products on the market, the current Authorised Representative would be responsible for handling those issues. If any of those issues would imply that the old Authorised Representative has neglected any of their tasks as Authorised Representative, it would seem logical that the old Authorised Representative would be held responsible. However, this is not laid down in any product-specific legislation.

What happens if an Authorised Representative or manufacturer becomes bankrupt?

Keeping documents is one of the key responsibilities of an Authorised Representative. There are different requirements for how long this should be kept depending on the product. For example, medical devices require documents to be kept for 10 years.

If the manufacturer becomes bankrupt and therefore ceases to exist, the Authorised Representative will still keep the technical documentation for the products that currently exist on the market. If the Authorised Representative becomes bankrupt and ceases to exist, then the manufacturer will need to appoint a new Authorised Representative and transfer the documentation to the new Authorised Representative.

If both the manufacturer and Authorised Representative cease to exist, the situation will occur that the product is on the market but with no manufacturer or Authorised Representative. The documentation will most likely end up on a server or in storage where there is no knowledge that the documentation is there. If anything happens to the product on the market, there will be no company to contact. The current legislation does not outline anything specific for a situation like this. In these situations, there is no way to contact a responsible party and the documentation would be treated as unavailable.

What if the Authorised Representative is in the UK, not the EU?

If the Authorised Representative has their place of business in the UK, then they should not be your Authorised Representative. You should immediately rescind all contracts and appoint an Authorised Representative based in the EU. The same applies to Notified Bodies.

Is the Authorised Representative legally responsible for defective or non-compliant products?

Depending on what is stated in the relevant EU legislation pertaining to the product, the Authorised Representative may or may not be legally responsible for defective or non-compliant products. For example, according to most CE marking regulations and directives, such as the Low Voltage Directive and Toy Safety Directive, the Authorised Representative does not hold any responsibility. However, if the product is under the Medical Device Regulation, the Authorised Representative is liable.

Generally, the manufacturer is responsible and liable for the product placed on the EU market.

What are the obligations my distributor must take on if they have to become my importer?

Unlike distributors, importers are legally and financially liable for any non-compliance of products entering the market. If the distributor takes on the role of the importer, they will need to be aware of this. The fines levied by each EU country can be significant if these obligations are not correctly followed, particularly if these have led to non-compliance with the MDR. Distributors may not be up to the task of fulfilling those obligations.

Can a distributor or importer be an Authorised Representative?

Some companies opt to use their distributor or importer as their Authorised Representative. Many distributors, however, may not be aware of the role and responsibilities of Authorised Representation. There are other issues to consider.

• The distributor’s name and address will be on all of your materials, no matter where they are sold in Europe. If the distributor changes, all labels, manuals, and packaging will need to be reprinted.
• A distributor should focus on the sale and marketing of your devices, not on regulatory affairs. If the European laws and guidelines are modified, the distributor will need to remain aware of these changes and notify the company when changes affect their products.
• The distributor, as your Authorised Representative, will have access to Technical File(s), which may include proprietary information. If the Competent Authorities question an incident or a non-compliance that occurred with the, it is important to ensure that the distributor will defend the company and not just protect their own interests.

How do I get an Authorised Representative?

It is important to choose your Authorised Representative wisely. Your Authorised Representative will have access to all files and information of the concerned products, so appointing a party that is not economically or commercially involved with products is a preferred choice for manufacturers.

Considering the Authorised Representative’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. This prevents legal complications and ensures that you, as the manufacturer, will only be notified of compliance matters that affect your product directly.

What are the key factors in choosing an Authorised Representative?

You should make sure, above all, that your Authorised Representative is someone who you can trust. They should have a good reputation, be reliable, and have strong credentials. Having experience in the industry your product exists in is also very valuable.

• Steps to choosing an Authorised Representative
• Find an Authorised Representative who has had at least a few years of experience, has dealt with a variety of different products, and preferably has a compliance background
• Choose a pre-defined service plan or ask about any custom contract needs you may have
• Ensure all necessary paperwork is prepared prior (such as Technical Files and the Declaration of Conformity) and share it with your Authorised Representative
• Ask the Authorised Representative for their validation of any Technical Files or Declaration of Conformity
• Sign an agreement with the Authorised Representative and receive a certificate of representation
• Ensure the Authorised Representatives name, address and contact details are clearly displayed on your products

What is the new Regulation?

Regulation (EU) 2019/1020 aims to strengthen the market surveillance of products covered by EU harmonised legislation. This is to ensure the protection of health and safety, consumers, the environment, and public interests. In the realm of e-commerce, the Regulation means that a ‘fifth’ economic operator will now be included in the supply chain. Traditionally, economic operators were divided into four groups: manufacturers, Authorised Representatives, importers, and distributors. The fifth economic operator now being introduced is the Fulfilment Service Provider.

Why is the new Regulation being enforced?

The growing number of non-compliant products from e-commerce businesses has caused a series of problems in the EU market, including unfair competition and consumer risk due to non-harmonised standards. The EU subsequently developed the ‘Strategic Agenda 2019-2024’ (which includes the new Regulation 2019/2020), in order to address the regulation on market surveillance and product compliance. This update ensures that both physical and e-commerce businesses can continue to thrive and that the economic playing field remains fair and compliant.

What is a Fulfilment Service Provider under the new regulation?

In relation to the new Regulation, the ‘Fulfilment Service Provider’ is defined as an operator who is undertaking any two of the following services: warehousing, packaging, addressing, and dispatching, without having ownership of the products in question.

What will be the requirements of the economic operator?

Similarly to an Authorised Representative, the operator will be required to:

• Verify the required conformity documentation (such as the Declaration of Conformity and technical files)
• Represent the company in cooperating and liaising with market surveillance authorities, and
• Notify authorities in relation to any relevant safety or compliance issue

How is the responsible economic operator identified?

The name and contact details (including the postal address) of the responsible economic operator must be clearly presented on the product, it’s packaging, or with an accompanying document such as the Declaration of Conformity.

Conclusion

In conclusion, there are many factors that should be taken into account when appointing a European Union Authorised Representative. It is extremely important that any economic operators, including Fulfilment Service Providers, look into the legal obligations of their product and what measures should be taken to place the product on the European market. With the new Market Surveillance Regulation coming into force on 16 July 2021, it is imperative that businesses are aware of what this may mean for their products and act accordingly.

Certification Experts can offer the following Authorised Repersentative service, please do no hesitate to contact us.

• EU Authorised Representative
• EC Rep (EU Medical Devices)
• UK Authorised Representative
• UK Responsible Person (UKRP for Medical Devices)