MEDICAL DEVICES REGULATORY AFFAIRS, Prague, Czech Republic
8-9 June 2017
This conference brought together leading professionals from the medical device regulatory affairs sector from across Europe to discuss the future strategies for medical device companies. The main topics were focused on compliance with the new medical device regulations in Europe, including risk, quality management, and clinical issues, including study requirements and clinical evaluation. The conference also offered excellent networking opportunities.
With the Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) now having been published in their final forms, both the device and diagnostic industries are preparing to achieve compliance. As notified bodies play an enhanced role in the European healthcare setting under new rules, industry is anxious to learn more about the regulatory challenges ahead. It is critical for the industry to understand the increased focus on new responsibilities and requirements for all economic operators, including those involved in manufacture, importation and distribution.
In this context, DLC was the only 'Gold Sponsor' of the conference, and DLC's President, Dr. Maria E. Donawa, spoke on the first day on the subject of 'Clinical Evaluation: Meeting the challenges of evolving European requirements'. DLC also had a booth at the associated exhibition, where both Dr. Donawa and Roger Gray, DLC's VP Quality and Regulatory, were available to speak with existing and prospective clients.