European Medical Device Authorized Representative for Medical Devices (EU Rep)


The European Union (EU) requires any non-European manufacturer who intends to sell their medical devices in any of the EU Member States to designate a sole EU medical device authorized representative with a physical address within one of the EU Member States.


What are the duties of an EU Medical Device Authorized Representative (EU Rep/ EU AR)?

The role of an European Medical Device Authorized Representativein (also referred to as an EC REP or EU AR) is varied and challenging. The main duties include, but are not limited to, the following:

  • Providing medical device representation services with a registered address within the European Union (EU), as EU medical device authorized representative
  • Reviewing and keeping all technical documentation available for inspection by the European Competent Authorities (Ministries of Health), provide consultancy services as needed
  • Prepare the medical device submissions and notifications for the proper European Competent Authorities (Ministries of Health)
  • Completing the medical device registrations in the EU national databases
  • Provide consultancy services related to medical device Incident Reporting
  • Represent the medical device manufacturer towards the European Commission, EU Competent Authorities and/or EU Notified Bodies
  • Safeguarding and ensuring compliance with constant regulatory updates as a EU Authorized Representative Service
  • Provide medical device consulting for regulatory and quality departments on European Regulations as a EU Medical Device Authorized Representative Service


As your European Medical Device Authorized Representative (EU), RQMIS will
:

  • Registration of your Medical Device acting as Authorized Representative in "Europe" (EU). Register the manufacturer in EUDAMED database.
  • Provide EU Authorized Representative consultancy service for the medical device labeling throughout European Union (EU) market
  • Documentation check, into the EU Authorized Representative Service
    • Verify the Declaration of Conformity (DoC) for Europe (EU)
    • Review the medical device Technical Documentation
    • Review where applicable that an appropriate conformity assessment exists
    • Keep the previous documentation (Declaration of conformity, Technical Documentation, certificates issued by Notified Body and amendments) at the disposal of competent authorities (at least 10 years; 15 for implantable devices)
  • Make available to European Competent Authorities (Ministries of Health, Notified Bodies) a current copy of the medical device Technical Documentation and/or CE Declaration of Conformity for inspection as requested
  • Vigilance report for medical device into the EU Authorized Representative Service
    • Immediately tell the medical device manufacturer about complaints and reports from European Competent Authorities, patients and users related to suspected incidents caused by their device.
    • Assistance with European Competent Authority communications acting as EU Authorized Representative
  • Registration check (EU Medical Device Authorized Representative services)
    • Verify that the medical device manufacturer is complying with the registration of the Unique Device Identification according to Article 27 (Medical Device Regulation EU 2017/745).
    • Ensure the registration of the medical device manufacturer and importers are completed according to Article 31, (Medical Device Regulation EU 2017/745).
  • Audit support, acting as Medical Device Authorized Representative in Europe
    • In case requested by the competent authorities, the European Medical Device Authorized Representative service should give all the information and documentation necessary to prove the conformity of a device, in an official language.
    • The European Medical Device Authorized Representative service involves to keep the manufacturer informed of any request coming from the competent authorities.
    • Verify that the European competent authorities receive the samples or is given access to the medical device, by the medical device manufacturer. If not, the European Medical Device Authorized Representative can provide that service.
    • An other service provided by the European Medical Device Authorized Representative is to cooperate with the European competent authorities for any preventive or corrective action taken to cut or mitigate the risks posed by medical devices.

Need an European Medical Device Authorized Representative service (EC REP or AR)?

You've come to the right place. Our experienced consultants will provide you the service of review your Technical File, register your medical device or IVD, as required, and respond to any questions or concerns from the European Competent Authorities. Also, our experts consultants will send frequent updates to all our European Medical Device Authorized Representation clients with important regulatory updates focused on Europe, as part of our European Medical Device Authorized Representative service.

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