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EU Authorised Representative

Med-Di-Dia can act as your EU authorised representative

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What is an EU Authorised Representative? (E.A.R. / EU-AR)

The European Union requires any foreign manufacturer from outside of the European Union who intends to place their devices in any of the Member States to designate an authorised representative (EC REP) with a physical address within one of the Member States. Article 11 of the MDR states: 

 

where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 10, the authorised representative shall be legally liable for defective devices on the same basis as, and jointly and severally with, the manufacturer

Under MDR and the IVDR, the EU Authorised Representative has more responsibilities than previously under the 'old' Directives. As per Article 11 of the MDR, the manufacturer and the EU Authorised Representative should agree the specific tasks in a mandate which the EU Authorised Representative will undertake on behalf of the manufacturer.

 

Under these new regulations, the EU Authorised Representative role is not a 'post-box' service. In fact, they are obliged to undertake certain compliance tasks which cannot be delegated or outsourced - see 'responsibilities' below.

Under the Medical Device Regulation and In-Vitro Diagnostic Regulation, the EU Authorised Representative will include the following responsibilities:

  • Verify that the manufacturer’s device has undergone the appropriate conformity assessment
  • Ensure that the Declaration of Conformity and the technical documentation has been completed
  • Keep a copy of the Declaration of Conformity and the technical documentation along with a copy of the device certificate including supplements and amendments for a suitable time
  • Ensure that the details of the manufacturer, EU Authorised Representative, importer and distributor are uploaded to an electronic system and kept up to date
  • Provide Competent Authorities with any information or documentation required to demonstrate that the device meets conformity
  • Forward any requests to the manufacturer from the Competent Authorities for sample devices
  • Cooperate with Competent Authorities on any corrective or preventative actions
  • Immediately inform the manufacturer of any complaints or complaints related to their devices
  • Terminate their mandate as EU Authorised Representative if the manufacturer acts contrary to the MDR

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What impact has Brexit on the operations of medical device and in-vitro diagnostic companies?

As from 1st January 2021, all manufacturers based in Great Britain (England, Scotland and Wales) who place their devices on the market in the European Union must contractually engage an EU Authorised Representative so as to keep their devices on the EU market. This is a mandatory requirement because on this date Great Britain became a third country and therefore, outside Europe. It is also a mandatory requirement that the details of the EU Authorised Representative must be listed on the device label.

 

The requirements for placing devices on the market in Northern Ireland (NI) differs from those which apply to Great Britain (England, Scotland and Wales).  Understanding the regulatory requirements for Northern Ireland under the Northern Ireland Protocol is a complex subject and specialist advice should be sought.

Med-Di-Dia can support UK companies keeping their devices on the EU and NI markets

 

For more information see our post for UK companies at:

 

Impact of Brexit on UK Manufacturers

Benefits of using Med-Di-Dia as your EU Authorised Representative?

  • Use of Med-Di-Dia’s name and address for CE Mark labelling
  • Support for creating and updating technical documentation as per the MDR
  • Registration of your device(s) with the Irish HPRA and EUDAMED when available
  • Provide support with Competent Authority questions related to the client’s device(s)
  • Presentation of the client’s technical documentation to Competent Authorities upon request
  • Contact the manufacturer to inform them of any reported complaints related to their devices
  • Access to a monthly regulatory intelligence newsletter outlining updates in the EU regulatory landscape
  • Access to ad-hoc regulatory support when required

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Please complete the form below and we will be in touch.

 

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