REGULATION (EU) 2019/1020
EU-BASED ECONOMIC OPERATOR REQUIRED FOR PRODUCTS OF NON-EU MANUFACTURERS
Before July 2021, for many product categories, a self-declared CE certification was all that was needed to permit a product to be placed on the EU market. However, this is no longer the case.
On the July 16th 2021, EU regulation 2019/1020 came into effect. This requires non-EU manufacturers to have an EU-based Economic Operator to take responsibility for CE marked products placed on the EU market. The Economic Operator may be the manufacturer (if based in the EU); an Authorised Representative appointed by the manufacturer; an importer, or a fulfilment service provider.
This new Regulation has been adopted by the European Commission to ensure the safety of products sold within the EU. It also addresses the loophole created by E-commerce, which previously made the consumer responsible for ensuring that products bought online were in compliance with safety standards. It is intended to protect EU citizens from unsafe and non-compliant products being placed on the market.
EU-BASED ECONOMIC OPERATOR
Under the new regulation, the legally specified duties of the EU-based Economic Operator are:
- Verify that the EU Declaration of Conformity (DofC) or Declaration of Performance (DofP) and the Technical Documentation (Technical File) have been drawn up;
- Keep the DofC or DofP at the disposal of the authorities and ensure that the Technical File can be made available to the authorities on request;
- Whenever requested by the authorities, provide all the information and documentation necessary to demonstrate conformity (in a language easily understood by the authorities in the country concerned);
- If the Economic Operator has reason to believe that the product presents a risk, inform the authorities;
- Upon request, cooperate with the authorities to make sure that immediate corrective action is taken to remedy any non-compliance, and take action to mitigate the risks presented by the product, as requested by the authorities or on its own initiative.
HOW WE CAN HELP YOU
We have been helping North American manufacturers to CE mark their products since 2008. With the arrival of this new regulation, we can:
- Help you choose from the alternative approaches available under the Regulation;
- Review your certification documentation to check that everything is present;
- If necessary, arrange for an Authorised Representative who will act as your Economic Operator in the EU.
In the past, when requested, we have helped clients to find a company to act as a contact point within Europe but the new EU regulation requires a greater involvement by the responsible EU-based Economic Operator .
WHEN APPOINTED, YOUR AUTHORISED REPRESENTATIVE WILL:
- Review your Declaration of Conformity or Performance and your Technical File to check that it contains all the required information.
- Hold your DofC or DofP and keep them available for the Market Surveillance Authorities.
- As part of their contract with you, hold or have immediate access to your Technical File information in digital format for presentation to the Authorities upon request.
- Liase with the Authorities, and between you and the Authorities, in the event of any recall required by the Authorities.
Charges for this service will consist of a fee for the period of the contract plus charges based on a standard hourly rate for work involved in checking your Technical File and related information and acting as necessary in the event of action by the Authorities.
If you have any questions at all, please call Tony Baker at 416-500-7287 or email to box569@maww.com.
To get the complete low-down on CE Marking your product, call Tony Baker at 416-500-7287 or
toll-free at 1.855.222.6299 (MAWW)
For detailed explanations of other CE marking topics, click below:
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