Donawa Lifescience Consulting - EU Authorized Representative

Manufacturers of medical devices regulated by the Medical Device Directive (93/42/EEC), the Active Implantable Medical Devices Directive (90/385/EEC) and the In Vitro Diagnostic Medical Devices Directive (98/79/EC) who are located outside the European Economic Area (EEA) and with no subsidiaries in the EEA must designate an authorized representative to carry out certain regulatory activities.

Directive 2007/47/EC revised the Active Implantable Medical Devices Directive and the Medical Devices Directive with effect from 21 March 2010, making it a requirement for non-European manufacturers to designate an Authorized Representative - previously it was voluntary.

WHY SELECT DONAWA LIFESCIENCE CONSULTING

European Authorized Representative services are important because, in the event that a regulatory authority is unable to contact a company directly or expeditiously, this authority may provide information or documents to the Authorized Representative. This action is considered to be equivalent to providing the same information or documents to the company.

Therefore, medical device companies seeking Authorized Representative services 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 offers the following services:

assisting companies in understanding and complying with European medical devices requirements

identifying national language requirements

identifying national medical device registration requirements and completing the registration process

contacting Notified Bodies to carry out activities related to the CE marking process

serving as the official contact with European authorities if a Member State takes measures to withdraw a medical device from the market or prohibits or restricts its being put into service

receiving and transmitting information on adverse events related to a medical device

if a medical device is intended for clinical investigations, notifying European authorities of the Member States in which clinical investigations are to be carried out

maintaining technical documentation and clinical evaluation reports within the EU

Feel free to contact@donawa.com and see how we can assist you.

Regulatory References