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In order to better protect consumers and the environment in the EU, EU law requires that in order to achieve product traceability, products with the CE mark placed on the EU market by manufacturers must be marked with the manufacturer's name and contact address; If the manufacturer is from a country outside the EEA (including the EU and EFTA), the product must be marked with the name and contact address of both the manufacturer and the manufacturer's EU authorized representative. For example:
In order to improve the overall efficiency of market surveillance, the European Commission will be responsible for checking the efficiency of market surveillance and require all member states to meet minimum legal requirements and strengthen cooperation and exchanges. In addition, the European Commission will work with customs and with relevant stakeholders (manufacturers, EU authorised representatives, importers, distributors) to establish a product traceability system. The European Commission is focusing first on high-risk areas, such as medical devices.
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Hello, Odai's duties.
1) Responsible for liaising with regulatory authorities in various countries within the EU to deal with equipment complaints, adverse events and recalls;
2) upon request, save the technical file or the CE declaration of conformity for inspection by the competent authority;
3) Entrusted by the manufacturer, the product is registered in the EU and the free sale certificate issued by the EU is applied;
4) Provide the European representative logo and its registered address required for product packaging, labels and instruction manuals.
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An EU Authorized Representative is a natural or legal person who is expressly designated by a manufacturer located outside the EEA (including the EU and EFTA).
The natural or legal person may perform specific duties on behalf of a manufacturer outside the EEA in relation to the manufacturer under the relevant EU directives and laws.
According to the requirements of the market surveillance regulations issued by the European Union, from July 2021, all products with the CE mark must be entrusted to a person in charge of the EU to deal with the communication between the relevant ** department and the seller before they want to be placed on the EU market. Sellers also need to pay attention to affixing the European representative information on the goods, product packaging, packages or accompanying documents, if the European representative information is missing, it will be spot-checked by the EU customs, and it will also face a serious risk of seizure and destruction.
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1. It must be a product invention or process invention;
2. It is novel, i.e., it does not belong only to the prior art known to the public in any form before the filing date (including the priority date), but it is disclosed within 6 months before the filing date (including the priority date) due to obvious abuse of the relationship with the applicant or for the purpose of exhibiting at a specific international exhibition, which does not affect the novelty;
3. Be creative, i.e., not obvious to the general technical personnel in the relevant technical field;
4. Able to be industrially produced or used;
5. Full disclosure so that skilled persons in the relevant technical field can implement the invention;
6. An application can only involve one invention or a group of inventions belonging to the same invention idea, but a divisional application can be filed in the EPO;
7. It does not belong to the subject matter that cannot be patented, such as human or animal ** or diagnostic methods, new plants or animal varieties, substantial biological methods for the production of animals and plants, discoveries, mathematical methods, computational commotion machine software, commercial methods, etc.;
8. The invention shall not be carried out in violation of public order or public morality, such as cloning the human body or selling embryos for commercial purposes.
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A European Authorised Representative (EU) or European Authorized Representative is a natural or legal person who is expressly referred to as a jujube by a manufacturer located outside the EEA (including the EU and EFTA). The natural or legal person may perform on behalf of a manufacturer outside the EEA in the performance of specific duties required by the relevant EU directives and laws for that manufacturer.
PRODSG: German Product Safety Act PROD On September 23, the German Bundestag enacted a new "Equipment and Product Safety Act" (GPSG), known as the new "Product Safety Act" (PRODSG). The new PRODSG, which came into effect on December 1, 2011, replaces the previous Global Safety and Security Team with no transition period.
The main reason for this new PRODSG is the implementation of EC Regulation 765 2008, which sets out the certification and market surveillance requirements that came into force on 1 January 2010. The new PRODSG consolidates these regulations in accordance with EC Regulation 765 2008 and largely inherits the findings of the Global Security and Security Panel.
Generally, the European generation and PROD SG are done together.
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