REGULATORY AND QUALITY

Manufacturers of medical devices regulated by the Medical Device Directives/Regulations who are located outside the European Economic Area (EEA) must designate an Authorized Representative (AR) to be contactable by the national competent authorities and, under the new Regulations, carry out certain regulatory activities. 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 AR in Europe, and for the ARs themselves. Donawa Lifescience Consulting (DLC) has a standard AR agreement which reflects the recommendations included within this guidance.

Medical device companies seeking AR services should designate only those companies that are qualified to offer such services and that can represent the company’s regulatory interests in an appropriate manner. The new Regulations also stipulate that ARs must have a ‘person responsible for regulatory compliance’, with specific educational and work experience requirements. DLC meets these new requirements, and is able to provide expert regulatory advice to its AR clients on an as-needed basis.

Depending upon client company needs, Donawa Lifescience Consulting offers the following services:

• assisting companies in understanding and complying with European medical device requirements, including Eudamed entry
• 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
• receiving and transmitting information on adverse events and field safety corrective actions
• if a medical device is intended for clinical investigations, notifying applicable national competent authorities
• maintaining technical documentation and clinical evaluation reports within the EU