Iguana-Q provides EU authorised representative (EAR) services for non-EU manufacturers and to represent their certified products in the EU market. In Iguana-Q we have 15+ years of experience on product safety, testing, quality control, audit and certification process. We have long and

extensive experience with EU Directives and Regulations. Our consultant has helped many clients to become EU compliant before entering the EU market. Iguana-Q is specialised in Machinery, Toy, Food Grade items, Electrical and Wireless equipment. In addition, Iguana-Q provides a cloud-based customer portal such that customers can interact with us seamlessly and digitally. Please feel free to contact us if you have any questions.

The main purpose of the Market Surveillance Regulation is to set up a high degree of control within the EU to conduct market surveillance on imported products, and it is expected that the authorities will do more frequent inspections after the 2019/1020 change. EU regulation 2019/1020 Market Surveillance regulation requires all non-EU manufacturers selling products to EU consumers to have an importer or an authorised product representative (EAR) within The EU. The regulation applies to a wide range of high-risk product sectors, including but not limited to machinery, toys, textile, electrical and electronic equipment. The regulation application begins on 16 July 2021.

First of all, you need to have test reports issued by a test lab to prove the product passes compliance requirements. If the product fails some of the tests, it may be necessary to change the product and do a retest before entering the product into the EU market to prove that your product is compliant with EU Directives and regulations.

Once the tests pass all the relevant directives/regulations, you need to prepare a technical document which describes the technical details of your product, provides information about the manufacturer, and lists the product compliance information. You will also need to prepare a technical file which contains all compliance documents. 

Lastly, you as a manufacturer or your EU authorised representative (EAR) needs to prepare a EU Declaration of Conformity (DoC) to declare a product complies with the EU requirements and to take full responsibility for compliance with the applicable EU law. The DoC contains information about the manufacturer, the EAR, the product, its compliance details, and a declaration of responsibility. The DoC needs to be signed by the EAR. It is important to pay attention to the details of a DoC otherwise you risk being rejected by the authorities even if the product is fully compliant.

There is no simple answer to this question. Each product has specific compliance requirements towards a given destination country. Although there are common EU compliance standards (Harmonised standards), there are also national standards maintained by individual countries. If you have a new product to be released, it is highly recommended to talk to EU product regulatory experts or a test lab to discuss the legal and product test requirements. 

Furthermore, as product compliance is highly complex, you may get different answers from different labs (See question 4 below). It is wise to do research before you meet with these experts in order to qualify their guidance and to be in control. If you are in doubt, seek a second opinion from another expert, for example, your EAR.

Due to the complexity of the regulatory requirements, it is not surprising that different labs may give you slightly different answers. A well known lab usually has its core strength and specialities, particularly on the regulations from its main territories. For example, Intertek is very familiar with the directives in the UK, TÜV Rheinland for Germany, Kiwa for Finland and Sweden. In addition, some labs are specialised in particular industries, e.g. Ship construction, oil & gas. 

As a result, depending on the nature of a product and the targeted market, it is wise to research which labs have strong experience and select the best match for your budget.

After Brexit the UK has its own compliance label called the UKCA marking, and it no longer follows the European CE marking. There are minor differences between the UK standards and the EU standards. In many cases the approved test reports and technical documents can fulfill both marking requirements. However you will need two different DoCs for the UK and for the EU. Talk to your EAR to ensure you meet both sets of requirements and have the DoC documents ready for both cases.