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EU AUTHORIZED REPRESENTATIVE

Medical devices

In Europe, medical devices are regulated by the Medical Devices Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC), and the In Vitro Medical Devices Directive (98/79/EC). For manufacturers located outside the European Economic Area (EEA) and associated countries, from 21 March 2010 they must designate one European Authorized Representative (AR) for each medical device family. The AR is designated by the manufacturer to carry out certain regulatory activities under the European Directives for medical devices.

Certain member states also require sponsors of medical device clinical investigations being carried out in that country to designate an AR, so that there is a local organization or contact that can be referred to by the national Competent Authority in the event of questions or problems. 

Why select Donawa Lifescience Consulting?

European AR services are important because in the event that a regulatory authority is unable to contact a company directly or expeditiously, it may require from or provide to the AR information or documents pertaining to the clinical investigation. This action is considered to be equivalent to providing the same information or documents to the sponsor.

Therefore, medical device companies seeking regulatory representation in Europe should designate only those companies that are qualified to offer these services and that can represent the company's regulatory interests in an appropriate manner. Donawa Lifescience Consulting meets this requirement. 

Donawa Lifescience Consulting AR services

Depending upon client company needs, Donawa Lifescience Consulting (DLC) offers the following clinical investigation AR services: 

• Assisting companies in understanding and complying with European medical device requirements
• Maintaining the necessary technical documentation within the EU*
• Identifying clinical study national language requirements
• Identifying national medical device registration requirements and completing the registration process where required
• Serving as the official contact for the study with relevant Competent Authority

* Part of the documentation that should be kept within the EU is the statement required by Annex VIII of the MDD and Annex 6 of the AIMDD. This document must state that:

“The device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.”

DLC can help companies develop the documentation to support this statement, for example the Essential Requirements Checklist and risk management file.

Please feel free to contact us to request further information or a sample AR agreement for clinical study representation.