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CE MDR
[CE/MDR] Authorized representative
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- 2017-07-24 19:28:00
새로 개정된 Medical Device Regulation 에서는 Article 11, 12에서 유럽대리인에 대해 별도로 설명하고 있습니다.
또한 3항에서 유럽대리인의 의무를 설명하고 있으며, 그 내용은 아래와 같습니다.
3. The authorised representative shall perform the tasks specified in the mandate agreed between it and themanufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
인증된 대표는 본 계약과 제조 업체 간에 합의된 임무에 명시된 직무를 수행해야 한다. 유럽대리인은 요청 시 관할 당국에 위임된 권한의 복사본을 제공해야 한다.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
의무는 다음과 같아야 하며, 제조자는 유럽대리인이 다루는 기기와 관련하여 최소한 다음과 같은 작업을 수행해야 한다.
(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; 5.5.2017 L 117/25 Official Journal of the European Union EN
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation
상세 내용은 Regulation 원문을 참조해주시기 바랍니다.
감사합니다.
또한 3항에서 유럽대리인의 의무를 설명하고 있으며, 그 내용은 아래와 같습니다.
3. The authorised representative shall perform the tasks specified in the mandate agreed between it and themanufacturer. The authorised representative shall provide a copy of the mandate to the competent authority, upon request.
인증된 대표는 본 계약과 제조 업체 간에 합의된 임무에 명시된 직무를 수행해야 한다. 유럽대리인은 요청 시 관할 당국에 위임된 권한의 복사본을 제공해야 한다.
The mandate shall require, and the manufacturer shall enable, the authorised representative to perform at least the following tasks in relation to the devices that it covers:
의무는 다음과 같아야 하며, 제조자는 유럽대리인이 다루는 기기와 관련하여 최소한 다음과 같은 작업을 수행해야 한다.
(a) verify that the EU declaration of conformity and technical documentation have been drawn up and, where applicable, that an appropriate conformity assessment procedure has been carried out by the manufacturer;
(b) keep available a copy of the technical documentation, the EU declaration of conformity and, if applicable, a copy of the relevant certificate, including any amendments and supplements, issued in accordance with Article 56, at the disposal of competent authorities for the period referred to in Article 10(8);
(c) comply with the registration obligations laid down in Article 31 and verify that the manufacturer has complied with the registration obligations laid down in Articles 27 and 29; 5.5.2017 L 117/25 Official Journal of the European Union EN
(d) in response to a request from a competent authority, provide that competent authority with all the information and documentation necessary to demonstrate the conformity of a device, in an official Union language determined by the Member State concerned;
(e) forward to the manufacturer any request by a competent authority of the Member State in which the authorised representative has its registered place of business for samples, or access to a device and verify that the competent authority receives the samples or is given access to the device;
(f) cooperate with the competent authorities on any preventive or corrective action taken to eliminate or, if that is not possible, mitigate the risks posed by devices;
(g) immediately inform the manufacturer about complaints and reports from healthcare professionals, patients and users about suspected incidents related to a device for which they have been designated;
(h) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation
상세 내용은 Regulation 원문을 참조해주시기 바랍니다.
감사합니다.
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