Why do I need an Authorised Representative service?
Starting on the 16 July 2021, a new EU regulation, (EU) 2019/1020 comes into force requiring non-EU manufacturers to have an EU representative’s name and address on all products placed on the EU market.
If the UK leaves the EU single market, which currently seems to be the intention of the UK government, manufacturers based in the UK will require the services of an EU-based economic operator if they wish to market their products in the EU.
How much does an Authorised Representative Service cost?
Our pricing is based on individual requirements. Please contact us for an estimate.
Do I need to give you a copy of my Technical File and Declaration of Conformity?
We will need to keep a copy of each product's Declaration of Conformity or Declaration of Performance but not the rest of your technical file. However you will need to produce the technical file if requested by a market surveillance authority.
What if I don’t have all of the required documents?
You are required to have a complete Technical File and Declaration of Conformity if your product is CE or UKCA marked before you place your product on the market and before we will represent you. If you don’t have these documents, we will refer you to Conformance Ltd who can help you complete them.
What happens at the end of my Subscription?
The subscripton lasts a year and is renewable, we will send you a subscription reminder in time for you to renew the contract if you wish to.
If you do not renew, or if you cancel the contract, we will simply respond to any enforcement requests by telling the enforcement authority that we are no longer acting on your behalf and giving them your details so they can contact you directly if they choose to.
Do I need a separate Authorised Representative contract for each individual product I sell in the EU?
It depends on your product range. We have a number of services on offer to cover:
- An single product or piece of equipment sold once.
- An single product type sold regularly.
- A product family covered by a single technical file.
- A wider product range with multiple technical files
What is the ‘Market Surveillance Regulation’?
Officially known as “REGULATION (EU) 2019/1020 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011” the Market Surveillance Regulation is a measure intended to make it easier for safety enforcement authorities to identify someone responsible for placing goods on the market, primarily to make it easier to take action in the event that there is a problem which could create a danger for users and others.
What is the ‘Goods Package’?
The Goods package is a series of measures proposed by the European Commission to strengthen enforcement action against faulty and dangerous goods sold in the EU and improve co-operation between Member States in dealing with unsafe products. It includes the Market Surveillance Regulation.
When does the Market Surveillance Regulation come into force?
Compliance with the requirements of the MSR will be compulsory for product sold within the EU from 16 July 2021.
I’m importing CE marked goods into the EU. Can I wait until July before I have to mark the goods with the name and address of my Authorised Representative?
Most of the CE marking directives already require the name and address of a responsible person based within the EU to be marked on products, and have done so for some years.
Will the Market Surveillance Regulation be implemented in the UK?
No, but the UK has said it is looking at similar measures.
If the Market Surveillance Regulation is not implemented in the UK, where does the requirement for marking the name and address of a responsible person within the UK come from?
All of the CE marking directives and regulations which were in force at the end of 2020 are now part of UK law so the requirement to identify a responsible person within the UK is inherited from the transposition of the CE marking requirements into UK law.
What is the difference between the United Kingdom (UK) and Great Britain (GB)?
The United Kingdom is England, Scotland, Wales and Northern Ireland. Great Britain is just England, Scotland and Wales.
Who are the ‘market surveillance authorities’?
This varies from country to country. In the UK the MSA for most products used in factories, on building sites, in agriculture or in industry is the Health and Safety Executive, and for consumer products, offices and shops it is the local authority Trading Standards Service. EMC and radio products are regulated by Ofcom and medical devices by the Medicines and Healthcare products Regulatory Authority (‘MHRA’). Similar organisations exist in most EU Member States. In some states (but not everywhere) customs officers also have enforcement powers for product safety.
The legislation says there must be a ‘person’ who acts as manufacturer or authorised representative or other economic operator. Does that mean we have to identify a specific individual to undertake these tasks?
No. The responsible ‘person’ can be either a natural or a legal person. A ’natural person' is an individual human (i.e. a ‘person’ in the normal sense of the word) whereas a ‘legal person’ is a registered company (or some other legally recognised organisation such as a limited liability partnership).
My products do not need CE marking. Does the requirement for an Authorised Representative still apply?
Yes, in most cases the General Product Safety Directive (GPSD) applies and this mandates that product must have a ‘manufacturer’s representative’. This is basically the same function as an Authorised Representative.
What about food, medicines, cosmetics, chemicals etc. Do they need a local representative?
These products are subject to different rules which are not explained here. Authorised Representative Service does not currenly represent these products.
If we sell into the UK and the EU do we need two names and addresses on the product (a UK and an EU one)?
Yes.
We sell in the UK only but sometimes our products are purchased by others and resold into Europe. Do we need two addresses on the product (one UK, one EU)?
No, it will be the importer’s responsibility to put their address on the products which are sold in Europe, not yours.
Does the name and address of the Authorised Representative have to be given on the Declaration of Conformity?
Yes.
We are a UK company that sells into the EU via a distributor based in Germany. Does that distributor automatically become our Authorised Representative?
No. The legislation says that an Authorised Representative must have a written mandate from the manufacturer which describes the duties that the Authorised Representative is expected to undertake.
We manufacture and assemble electrical products in the UK. We self certify all our products and have a technical file etc. We sell some products in the EU, but only directly to the end user. Can we continue to do that without any EU representation if selling directly to the end customer and not via a dealer or importer?
No, you must appoint an Authorised Representative.
We are a subcontract manufacturer of electronic products based in Ireland. Most of our customers are in the UK. We do not do any design work, all our products are specified by the customer and we just manufacture to drawings supplied by them. Our products are only sold to the company which designs them, we never sell to others or on the open market. Do we need an Authorised Representative in the UK?
Your products are not being ‘placed on the market’ so no, you do not need a representative.
If the delivery paperwork has the importer’s name and address on it will that be sufficient?
The legislation says that the importer’s details must go on the product, in its instructions or on the packaging.
Does the technical file have to be kept on EU/UK soil?
No, the legislation does not specifically require this, it says that the manufacturer must keep the technical information “at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request”.
Our company works on the basis of dealerships. We have dealers across the EU. What happens if we do not appoint an Authorised Representative?
If you do not specifically appoint an Authorised Representative then your dealers will each have to take responsibility for the products they sell as if they were the importer. This means they will have to mark the machines with their name and address and act as the contact point in the event of a market surveillance action. You will need to supply them with copies of your declarations, and also a copy of the technical file if it is requested.
We have a distributor in Germany who also distributes similar products made by one of our competitors. Do we have to provide them with a copy of our technical file?
In theory the technical file information could be passed direct from you to the market surveillance authority, but this will only be possible with the co-operation of the distributor. If you want the information to remain confidential then you should appoint an Authorised Representative.
We import products from China and sell them under our own name in the UK and Europe. What are our obligations?
The fact that you re-brand the products means that you are the ‘manufacturer’ according to the CE/UKCA mark rules. You have to be able to show that your products meet the applicable directives and standards, and you have to issue a Declaration of Conformity in your name. If you continue to sell in Europe, you will have to identify an ‘economic operator’ to act as your point of contact with the market surveillance authorities and if you do not appoint an Authorised Representative then the company which was distributing your products before the end of 2020 will become your importer by default.
I am based in the UK and import products from China which I only sell within the UK. I know that sometimes products are purchased from me and shipped into Europe where they are re-sold. Do I have to appoint an Authorised Representative?
If you have no involvement in the resale or shipping of your product into Europe then no, you do not need an Authorised Representative.
I am based in the UK and import products from China which I only sell within the UK. I know that sometimes products are purchased from me and shipped into Europe where they are re-sold. Do I have to give my technical documentation to the re-seller if they get a request for it from a market surveillance authority?
No, not unless you have agreed this with the re-seller at the time of sale.
Must all CE marked / UKCA marked products imported into the UK have the importer’s name and address on them?
Yes, the importer’s name and address must be on the product, instructions or the packaging.
We import and re-sell consumer electronic goods into the UK and Europe. Do we have to supply instructions in paper form or can they be supplied via a website link?
Certain specialist goods are allowed to be sold with instructions in electronic format, but consumer products must have the instructions in paper form.
What is the difference between an ‘Authorised Representative’ and a ‘Responsible Person’?
‘Responsible Person’ is the term used in UK medical devices legislation to mean the same as ‘Authorised Representative’ in the Medical Devices Regulation.