Home SiteMap English Korean

GLOBAL RA

ICMC (International Certification Management Center Co., Ltd.)

pic

icmcert@naver.com

pic

+82-2-851-3111

EU AR Service

EU Authorized Representative

EU Medical Device Regulation (EU) 2017/745 and Regulation (EU) 2017/746) define it as follows:
‘authorised representative’ means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer's behalf in relation to specified tasks with regard to the latter's obligations under this Regulation.




EU AR Servoce

Where the manufacturer of a device is not established in a Member State, the device may only be placed on the Union market if the manufacturer designates a sole authorised representative.
ICMC company offers AR service.




EU Authorized Representative for ICMC

We offer a variety of services, coworkers with AR which of Europe Union.

1
EU AR (Authorized Representative)
2
UK RP (Responsible Person)

From January 1, 2021, medical devices coming to the UK market will be regulated under UK MDR 202 and other manufacturers will be required to appoint a UK head similar to the EU's official representative.

3
CH-REP (Switzerland Authorized Representative)

Medical devices are excluded from the Swiss-EU mutual recognition agreement, requiring separate appointments of agents in Switzerland.




ICMC Authorized Representative work

1
Register medical devices with relevant authorities in the country prior to the marketing of medical devices
2
The role of key liaison officers in contact with all national authorities
3
Provide customers with the authority to indicate the name and address of European agents on medical device labels, packaging and instructions for use
4
Keep the latest version of technical documents and maintain confidentiality for cooperation with European authorities
5
Storage and maintenance of reports on the evaluation of all data collected during clinical evaluation
6
In cooperation with customers and distributors, serious medical device accidents and on-site safety corrective measures to the relevant authorities



For further information, please find refer here Article 11 Authorised representative(Regulation (EU) 2017/745) or Authorised Representative Guidance(MDCG 2022-16 - Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746)




Benefits of ICMC's EU Authorized Representative Service

★ For cooperation with European authorities, we maintain the latest version of technical documents. I am well aware of the European licensing environment and related authorities, so I can represent the best interests of customers.
In addition, we promise to maintain confidentiality and expedite processing on behalf of all the customer's regulatory responsibilities and interests..

★ ICMC specializes in CE consulting work necessary for acquiring CE Marks for essential requirements when entering Europe (EU).
The AR service required for CE certification is represented by the European specialized agency.

★ICMC will provide good services to domestic companies through many experiences in AR work such as Europe, the UK, and Switzerland.