With the upcoming overhaul of the European Union's Medical Device Regulation and Approval Process, the regulatory landscape will change dramatically. Quality Assurance and Regulatory Affairs staff at many medical device manufacturers have already begun preparing for these changes.
To help manufacturers tackle these challenges, TÜV SÜD is pleased to offer its 2017 MDR Workshop on March 13, 2017 in San Diego, California. Located at the Kimpton Palomar Hotel, registration for the workshop will open at 1:30 p.m. PST, while the workshop itself runs from 2:00 p.m to 6:00 p.m. A group reception and buffet for refreshment and networking will follow.
We are excited to announce that Dr. Bassil Akra, TÜV SÜD's global director at our Clinical Center of Excellence, will be leading the event. With a distinguished career in research and development, quality management and regulatory affairs, Dr. Akra is deeply involved with the development of the EU's guidance and standards in his capacity as a member of the Working Group on Clinical Investigation and Evaluation.
Dr. Matthias Fink will also speak, along with Dr. Gerold Labek and Dr. Yuan Li of TÜV SÜD.
The focus of this workshop will be the regulatory requirements surrounding complex, Class III medical devices such as orthopedics, implants and those that are used in contact with the spinal column. Devices that were previously certified on an equivalence basis and those for which there is not a significant amount of clinical data may not be certified under the new regimen.
Overall, the MDR calls for increased standards for clinical evidence, more intensive documentation, an expansion of the scope of covered devices, and the implementation of unique device identification codes for better tracking of potential defects.
As the world's largest EU Notified Body, TÜV SÜD's range of auditing, certification and testing services make us exceptionally equipped to help manufacturers promote safety and manage risk. Device safety and compliance becomes a more complex task everyday, and our services, knowledge and workshops can help you navigate these intricate waters.