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.
In January 2012, the European Commission published a guidance document for Authorised Representatives, MEDDEV 2.5/10, providing guidelines for both manufacturers seeking to designate an Authorised Representative in Europe, and for Authorised Representatives themselves.
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 is also a founding member of the European Association of Authorised Representatives, an alliance of European Authorised Representatives who have joined forces to promote professional conduct and competence. EAAR members possess a shared vision of enhancing the quality of European Authorised Representation and aim to provide an understanding of European Authorised Representatives’ responsibilities to other stakeholders.
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