According to the "EU Market Surveillance Regulation 2019/1020": From July 16, 2021, when a manufacturer located outside European Union exports products with the CE marking to the territory of EU, it is necessary to designate a natural or legal person in the EU as the European Authorised Representative of the manufacturer. Then, the authorised representative will represent the non-EU manufacturer to communicate with the competent authorities of EU Member States on related product compliance issues. At the same time, the manufacturer must print the name and address of its authorised representative on the label, packaging and instructions of CE marking product, otherwise it will be regarded as illegal.
Responsibilities and obligations of European Authorised Representative
1. Verify EU declaration of conformity or declaration of performance and technical documentation.
2. Keep EU declaration of conformity or declaration of performance and technical documentation for at least 5 years, and ensure that the technical documentation can be made available to market surveillance authorities upon request.
3. Upon a reasoned request of the market surveillance authority, provide the authority with all information and documentation necessary to demonstrate the conformity of the product in a language which can be easily understood by that authority.
4. When the product has potential risks, communicate with the market surveillance authorities in a timely manner.
5. Assist manufacturers outside of EU and EU market surveillance authorities to correct non-compliance issues, and provide assistance for accident reports, notifications, and recalls of products.
How to choose an excellent EAR?
1. Professional regulatory research capabilities to help companies understand and respond to EU regulations;
2. A legal registered address and permanent office in EU and able to respond to the inspections by the EU competent authority at any time;
3. Sufficient technical capabilities to verify and review company technical documents, implement internal reviews, and reduce quality risks;
4. Sound public relationships as well as rich experience to help manufacturers communicate with relevant EU authorities.
The advantages of CIRS Group as an EAR
1. High reputation: As a world leading regulatory advisory service organization, its subsidiary in Ireland is one of the world largest EU REACH regulation only representatives (OR). Its brand is highly recognized both at home and abroad.
2. Technical competence: With a technical team comprising of more than one hundred experts, CIRS has researched into the global environmental protection regulations for more than a decade. To serve customers around the world, CIRS has established several branches in Hangzhou, Ningbo, Nanjing, Ireland, the United States, South Korea.
3. Government support: CIRS Group is a regulatory service agency recommended by the General Administration of Quality Supervision, Inspection and Quarantine and the Ministry of Commerce. It has also been recognized and supported by the governments of Japan and South Korea, the European Chemicals Agency (ECHA) and the Irish government.
4. Service capabilities: CIRS Group is able to provide one-stop services including regulatory tracking, consulting, supply chain management, compliance registration, testing, product compliance informationization, and data analysis.
Address: 11F Building 1, Dongguan Hi-Tech Park, 288 Qiuyi Road, Binjiang District, Hangzhou 310052, China
Tel:+86 571 8720 6555 Fax: +86 571 8720 6533 Email: Info@cirs-group.com
Address: CIRS, Regus Harcourt Centre, Dublin, Ireland, D02 HW77
Tel:+353 (1) 477 3710