The regulation EU/2019/1020 requires manufacturers from non-EU countries to appoint an authorised representative within the EU to ensure the traceability of product “safety” during circulation and use after the product is placed on the EU market. Technical documents must be maintained in the European representative for 10 years for inspection by EU local authorities at any time.
According to regulatory requirements, manufacturers outside the EU must require a responsible person designated by Europe, and the authorised representative must be located in the European Economic Area and have a business registered address. The competent authorities of the member states can find an authorised representative at any time to check whether the overseas manufacturer has fulfilled the duties required by the relevant EU directives and laws.
The regulations require that all products that fall under CE scope must be marked with company name and address of the European generation while the CE mark is required on the packaging. CE means that the product compliant with the safety compliance certification.
The Purpose of European representative is traceability. Client and customs or the EU authorities
Why need an EU/UK Representative company?
As of July 2021, companies located outside the EU, but selling B2C to consumers in the European Union, must have an authorised representative. after the UK leaves the EU, any UK-based Authorised Representative will no longer be recognised under EU law. This means they will not be recognised as able to carry out tasks on the manufacturer’s behalf for the purposes of placing products on the EU market. In order to place devices on the EU market, manufacturers with an Authorised Representative based in the UK will need to establish a new Authorised Representative in an EU country.
Great Britain does not recognise authorised representatives and responsible persons based in the EU. If you need to use an authorised representative or responsible person, they will need to be based in the UK for products being placed on the GB market.
The role of the authorised representative can be summarized as follows:
1. The authorised representative authorizes the non-EU company to use their address on the packaging (which is mandatory)
2. The authorised representative holds the technical file, test report, and other relevant compliance documents
3. The authorised representative communicates with the national authorities (e.g. market surveillance authorities) on behalf of the non-EU company
There are a number of companies acting as European Authorised Representatives as a paid service, some of which are listed in this article. These companies normally charge a yearly fee. That said, paying a fee alone is not sufficient, as you must also provide extensive documentation:
Business registration documents
Product liability insurance
Compliance documents (e.g. test reports, DOC)
In short, you need to have your act together before you can even appoint an authorised representative. Keep in mind that the customs authorities can, and will, confiscate and destroy inbound shipments without an authorised representative address.
What We Can Do
If you choose to appoint us as an Authorised Representative to act on your behalf, we are able to provide the following services:
Approving the affixing of the CE Mark and/or UKCA Mark and, where relevant, other markings and information to your Product(s);
The preparation and authorisation of EU and/or UK Declarations of Conformity;
The maintenance of Declarations and associated Technical Documentation;
Liaising and cooperating with national authorities during any enquiries into compliance;
Providing national authorities with information and documentation necessary to demonstrate compliance and conformity;
Negotiating with national authorities on behalf of clients about methods to be taken to eliminate any risks posed by products;
The provision of advice on changing compliance requirements.
Accepting legal risk on behalf of Clients for compliance within the UK and EU.
If you are a manufacturer located outside of both the EU and the UK, but selling into those markets, there are many potential benefits to appointing we IGM as your Authorised Representative.