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New CE Mark Regulation

From 16 July 2021, CE Mark products cannot be sold in Europe without an Authorized Representative based in Europe.

Selling CE Mark Products online

New rules. New requirements.
If you are selling or considering selling CE Mark products online, you need to be aware of new rules that will affect you. On 16 of July 2021, the new regulation 2019/1020/EU – Market Surveillance and Compliance of Products Regulation – comes into effect. The new regulation will affect the European e-commerce and online trade business of market leading retailers like amazon. CE Mark products which are sold online will still have to meet the EU quality and safety requirements but now there is an additional need to have someone always present in the European Union who takes responsibility and is the point of contact for these products, an “Authorized Representative”.CE marked products manufactured outside of the European Union cannot be sold in the EU without an Authorized Representative as of July 16, 2021.

A dedicated service to keep you compliant.

From July 16, 2021, Amazon EU and equivalent retailers will require an Authorized Representative for each CE Mark product from non-European marketplace sellers.TÜV Rheinland and its partner company Obelis Group have developed a specialist service to help non-European sellers who don’t have a legal presence in Europe.

Stage 1 The Compliance Check

Stage 1 The Compliance Check

As part of the compliance check, TÜV Rheinland will first check whether your products are compliant with EU regulations and that no mandatory tests have been overlooked. If any missing mandatory tests are discovered, with over 250 laboratories around the world, we can arrange for testing at short notice, in any product Group, at a location convenient to you. Normally, a fully compliant result will initiate the second stage. In the unlikely event that the result of the compliance check turns out to be negative, Obelis Group can determine with the seller the necessary adjustments for the Stage 2 Representation Agreement to come into effect.

Stage 2 “Authorized Representative” Representation Agreement

Stage 2 “Authorized Representative” Representation Agreement

Obelis Group will enter into an agreement with the seller for one or more products as an “Authorized Representative”. The Seller can flexibly determine the duration of the agreement which is valid for distribution on the Amazon Marketplace and other equivalent retailers.

EU – Market Surveillance Regulation | TÜV Rheinland

A flexible process to support selling CE Mark products online

Proven partners connected for your success

Get connected for quality and confidence. A unique combination of market leading experience and expertise in testing/certification as well as European regulatory affairs. Dedicated partners with the power to keep you trading safely.

TUV Rheinland

TUV Rheinland

TÜV Rheinland stands for safety and quality in virtually all areas of business and life. Founded almost 150 years ago, the company is one of the world’s leading testing service providers with more than 20,000 employees and annual revenues of 2 billion euros. TÜV Rheinland’s highly qualified experts test technical systems and products around the world, support innovations in technology and business, train people in numerous professions and certify management systems according to international standards.

Obelis Group

Obelis Group

Obelis Group is a dynamic, quality-driven and service-oriented company based in Brussels, Belgium. After over 30 years, it is one of the largest and most experienced regulatory centers in Europe. It offers specialist expertise on the CE Mark and European Authorized Representative (EC REP) services as well as a broad spectrum of compliance solutions to manufacturers worldwide to help meet regulatory requirements in the 27 EU, 4 EFTA member states, and the UK. Obelis is also involved in a number of professional associations and EU commission working groups that keep it at the forefront of regulatory news & developments.

Selling CE Mark products online with no presence in Europe?

Downloads

pdf TÜV Rheinland - Fact Sheet for Online Sellers EN 298 KB Download

FAQ

CE Mark new regulations for online selling in Europe

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What products will this apply to?

CE Mark products that are sold online in Europe will all need an “Authorized Representative” based in and readily available for contact in Europe.

What is an Authorized Representative?

An Authorized Representative can be any one of the following:

  • A brand owner or manufacturer who has a legal entity and/or legally responsible person(s) in Europe
  • An importer legally based in Europe
  • An authorized representative based in Europe, who is legally elected by the brand owner or manufacturer
  • A fulfillment service provider based in Europe

What documents will I need?

  1. General product description, product list and pictures from each model/color
  2. Operating instructions
  3. List of safety-relevant components
  4. Certificates/data sheets for safety rel. Components
  5. Data sheet for LED and Luminary + Circuit diagrams if electrical driven
  6. Declaration of conformity
  7. Layout / artwork / label / packaging as print template
  8. Safety assessment
  9. If product is related to toys, infant or children, EN71 reports apply

Will your service apply only to selling on Amazon?

No it will be valid for all online selling in Europe.

Can I use Stage 2 without using Stage 1?

In order to deliver the Representation Agreement in Stage 2, it will be necessary to have successfully completed the Compliance Check in Stage 1.

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