유럽 대리인(Authorized Representative)

유럽 대리인 (Authorized Representative)

 

독일 현지 법인인 Lebenko GmbH는 유럽대리인 서비스 및 CE 마킹이후 독일 DIMDI 사이트에 등록 서비스를 제공하고 있다.

유럽 외에 위치한 제조사는 유럽대리인을 선정하여야 하고 해당 유럽대리인은 유럽대리인이 위치한 국가에 CE 마킹된 의료기기 제품 정보와 해당 의료기기 제조자를 등록해야 함을 의무화 하고 있다.

*유럽 대리인의 의무*

  • 유럽 ​​연합에 등록 된 주소를 제조업체에 제공
  • 유럽 ​​당국이 검사 할 수 있는 모든 관련 기술 문서 제공(declaration of conformity and technical documentation)
  • 유럽 ​​당국에 신고 절차 완료
  • 필요한 경우 국가 데이터베이스에 등록 프로세스 완료
  • 사고보고(perform with MANUFACTURER the analysis of the incident)
  • 유럽위원회, 당국 및 인증 기관을 향한 제조업체 대표
  • 지속적인 규제 업데이트로 규정 준수 보호
  • 유럽 ​​규정에 대한 제조업체 상담 및 조언
  • 의료기관의 불만 및 보고서에 대해 제조업체에 제공
  • Field Safety Corrective Action (FSCA)
  • 다국어 라벨 번역지원(번역비 별도)

유럽 의료기기 지침 (Medical Device Directive 93/42/EEC) 에서는 아래와 같이 유럽대리인을 정의 하고 있다.

 

유럽대리인에 대한 가이드라인 (GUIDELINE FOR AUTHORISED REPRESENTATIVES – MEDDEV 2.5/10)에 따르면 유럽대리인의 선정이 제조자의 책임에는 변동사항이 없지만 제조자로부터 정확히 지정 및 감시가 되어야 한다.

유럽대리인의 경우 단순히 유럽 외에 국가에서 의료기기를 제조하는 제조자들을 대신하여 유럽 내에서 발생하는 사항에 대한 연락창구 역할만을 대행 하는 것이 아니며 제조자가 CE 마킹이후 유럽대리인 국가에 의료기기 제품 등록 및 유럽 의료기기 시장에 판매되어진 이력 관리에 대한 정보를 제조자로부터 의무적으로 받아야 한다.

 

MEDDEV 2.5/10 : http://ec.europa.eu/DocsRoom/documents/10339/attachments/1/translations/en/renditions/native

 

    • Registration of the authorised representatives, manufacturers and devices.

 

    • An authorised representatives designated for a device covered by the obligation to notify the Competent Authorities is obliged to register with the competent authority of the member state in which he is located and to inform the Competent Authorities of the a ddress of the registered place of business of the manufacturer and the description of the devices concerned (AIMDD Art 10a, MDD Art 14).

A.1.3. Registration
In addition to the requirements described hereunder, there may be specific national
notification requirements, which are incumbent to the manufacturer, but which can be
delegated to the authorised representative.
MDD and AIMDD
Registration of the authorised representatives, manufacturers and devices
An authorised representatives designated for a device covered by the obligation to
notify the Competent Authorities (MDD class I, procedure packs and custom made
devices and AIMDD custom made devices) is obliged to register with the competent
authority of the member state in which he is located and to inform the Competent
Authorities of the address of the registered place of business of the manufacturer and
the description of the devices concerned (AIMDD Art 10a, MDD Art 14).
Registration of Clinical Investigations
The manufacturer or the authorised representative must notify of the intention to
carry out a clinical investigation to the Competent Authorities of the Member States in
which the investigations are to be conducted. They shall also notify when it ends and
shall make available the written report of the clinical investigation (AIMDD Art 10,
MDD Art 15). The manufacturer may delegate these tasks entirely or in part to the
authorised representative (MDD Annex VIII Section 2.2; AIMDD Annex VI Section
2.2).
IVDD
Registration of the authorised representatives, manufacturers, devices and
certificates
An authorised representative designated for a device covered by the IVDD is
required to register with the competent authority of the Member State in which he is
located and to inform the Competent Authorities of the address of the registered
place of business of the manufacturer, and to provide information related to the
devices, and to the certificates (Art 10).
Registration of performance evaluations
A manufacturer who does not have a registered place of business in a Member State
of the EU, and who wants to undertake a performance evaluation of a diagnostic

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device, within these territories, must appoint an authorised representative. The
authorised representative will communicate the information on the manufacturer and
on the device to the Competent Authorities of the Member State in which he has his
registered place of business. The declaration required for devices for performance
evaluation (IVDD Annex VIII) is drawn up by the manufacturer or the authorised
representative