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European Generation under MDR regulations

"Euroday" as a keyword appeared in 81 cases in MDR and only 19 cases in MDD:

• Article 35 of the preface: Introduction of AR

• Article 2, paragraph 32: Definition of AR

• Article 11: EU authorized representative AR

• Article 12: Change of AR for eu authorised representatives

• Section 15, Paragraph 6: Qualifications of Odai Person Responsible for Regulatory Compliance

• Verify manufacturer: 1. Declaration of conformity, 2.. Technical documents, 3. Whether the product conformity path is in compliance

• Keep manufacturer's: 1. Technical documentation, 2. Declaration of conformity, 3 certificate

• Complete product registration and verify the manufacturer also completes the registration obligation

• Immediately convey adverse event information to the manufacturer

• Provide product information, documentation and samples to eu authorities to assist them in preventing and mitigating adverse effects of product accidents

• If ODAI finds that the manufacturer violates the rules, ODAI shall immediately terminate oDAI's authorization

If the manufacturer's products go wrong in the EU, ODAI will be equally responsible.

Definition and duties of authorized representatives of eu

A European Authorized Representative is a natural or legal person specifically designated by a manufacturer outside the EEA(including EU and EFTA) of the European Economic Area. The natural person or legal person may represent a manufacturer outside the EEA to perform specific duties required of the manufacturer by the relevant DIRECTIVES and laws of the Eu.

The "Technical Documents" must be kept by the authorized representative/Representative of the Eu (authorized agent of the EU), and the authorized representative/Representative of the EU (authorized agent of the EU) must keep the latest "Technical Files" of all products with the CE mark. According to the eu law, to ensure that it can be provided to the CE supervision authority in the EU at any time and in a timely manner. After the last batch of products are put on the market, their technical documentation shall be retained with the EU authorized representative/EU representative (EU authorized agent) for at least 5 years. An authorized representative of the EU may also, on behalf of the manufacturer, apply for the registration of the device with the competent EU authorities.

European Generation under MDR regulations

Definition and duties of authorized representatives of eu

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