EU Authorized Representative

EU Authorized Representative

The term and responsibilities of the “Authorized Representative” (AR) have been coined by the European Parliament and the Council and is outlined in the Medical Device Directives. Thus, the Authorized Representative is a regulatory requirement applicable to manufacturers wishing to do business within the EU but not having a registered place of business within a Member State.

The European Commission has outlined a number of Guidelines which are easily legible and of a practical approach to accompany the Medical Device Directives, with a focus on actual application of the Medical Device Directives.

In short, the Authorized Representative is the door to Europe (EEA, Switzerland and Turkey) and a regulatory requirement for CE-marked medical devices in addition to investigational medical devices i.e. devices in clinical investigations.

Choosing your Authorized Representative

The foundation for a fruitful and proficient Authorized Representative relationship is a close and professional collaboration with the manufacturer based on real-time information sharing, particularly in relation to Competent Authority communications, regulatory compliance and the safety profile of a medical device.

In general terms, the responsibilities of the Authorized Representative are to act on behalf of the manufacturer in relation to:

  • Registrations with the EU Competent Authorities,
  • Undertaking of EU regulatory assignments e.g. lodging conformity assessments and drawing declaration of conformity,
  • Being available for inquiries from the EU Competent Authorities e.g. safety profile queries and queries in relation the technical file/investigation brochure,
  • Pre- and post-market safety reporting to EU Ethics Committees/Competent Authorities

Last, but not least - it is within the Authorized Representative's standard responsibilities to represent the view point of the manufacturer in lieu of their absence.

Qmed is your Authorized Representative of choice

As a full-service, ISO 9001 certified CRO, Qmed Consulting can provide you with the necessary Standard Operating Procedures (SOP´s) regarding Authorized Representative services. In addition, we also provide expert training throughout the Authorized Representative SOP framework, including maintenance.

To supplement or reinforce your internal capacities, we offer customized training sessions on the EU regulatory requirements related to Authorized Representative services, including:

  • Competent Authority registration processes & EUDAMED
  • Conformity assessment processes for the various classes of medical devices
  • CE-marking process
  • Clinical investigation process
  • Pre- and post-market safety surveillance processes
  • Processes related to recalls and safeguard clause

As your Authorized Representative, Qmed-Consulting provides you with proficient, hands-on services and in strict compliance with the Medical Device Directives. For more information on how we can help you, please contact us today.

Qmed-Consulting is a member of the European Association of Authorized Representatives EAAR.

Resources:

MEDDEV 2.5/10 Guideline for Authorized Representative