해외인증경영센터(주)해외유명규격 인증 전문기관
 
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[EU-CE]유럽대리인(AR)Selecting a European Authorized Representative MEDDEV 2.12-1 rev 4 -ICMC가 (EU AR Agnet)를 기술지원(소개)함.
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   Guidelines on a Medical Devices Vigliance System MEDDEV 2.12-1 rev4.pdf (115.4K) [1] DATE : 2009-06-22 23:43:14

ICMC는 국내 의료기기.진단기기등 제조하는 기업에게 유럽 수출시 필수적으로 등록해야하는 유럽대리인을 선임할 수있도록 기술서비스를 제공합니다.

ICMC는 유럽 소재 오스트리아.헝가리에 당사의 연락사무소를 운영하고 있습니다.
EU Authorized Representatives 문의--------->(주)해외인증경영센터로 연락바랍니다.
(Medical Devices Directives(93/42/EEC.Active Implantable Medical Devices 90/385/EEC and In Vitro Diagnostic Medical Device Directive 98/79/EEC)

What exactly is an EU 'Authorized Representative' ?

  1. The EU Authorized Representative is given the responsibility for maintaining the medical device manufacturers Quality Management System in the European Union.
  2. The EU Authorized Representative is the legal interface, between the EU Authorities and the non-European medical device manufacturer.
  3. The EU Authorized Representative is responsible for Medical Device Reporting (MDRs) The EU Authorized Representative must be available to the Competent Authorities (in charge of market surveillance) AT ALL TIMES, particularly in emergencies i.e. 365 days a year, (including holidays etc.)
  4. The EU Authorized Representative MUST be reflected on either the manufacturers product labeling, outer packaging and/or instructions for use. Can be called upon, (by the manufacturer), to initiate procedures for:
    • EC Type Examination.
    • EC Verification.
    • EC Declaration of Conformity (Class I and Class IIa Devices).

The Authorized Representative must meet all relevant deadlines. Failure to adhere to them carries painful penalties.

  • The Authorized Representative requires qualified staff i.e. some Member States have regulations over and above those required by Directive e.g. Safety Officer (for Germany) who must have a University Degree and a minimum 2 years Medical Device experience

  • The Authorized Representative requires the the 'Person' is capable to make qualified pre-submission judgement (in the event of an incident) on behalf of the manufacturer.

  • The Authorized Representative should be in a position to ensure that he provides qualified and trained (Regulatory Affairs) personnel to cover the responsibilities entailed.

  • The Authorized Representative ought to have sufficient of individual Member State requirements. (wherever applicable)

  • Appointing a distributor could lead to a system of hierarchy to evolve between Distributors; those not chosen may perceive themselves a being second class.

  • Appointing a distributor may cost time and money, should the manufacturer wish to change this particular distributor at any future time. Products carrying this distributors name on labeling or instructions for use, will however, be in the market long after the distributors have changed!

  • Appointing a distributor allows one distributor to be included on all labeling (and/or) instructions for use - an advantage to him but a huge disadvantage for his fellow distributors.

  • An Appointed distributor must allow the Authorities to access the Product Master Files, when asked. In the hands of a possible competitor, this could have disastrous long term consequences.

  • Appointing a distributor requires that he must remain neutral in all actions and responsibilities, especially toward 'rival' Distributors.

  • Appointing a distributor may require him to make decisions that are contrary to international sales objectives. This can potentially be hazardous