Since 2008 the European Medical Device Approval Process is undergoing a revision which is expected to be officially published in the first half of 2017. The new medical device regulation will include new requirements on implantable medical devices; and especially orthopedic devices and devices in contact with the spinal column. This new regulation does not include rules considering legacy devices but expect that these devices fulfill the new European requirements in order to be certified according to the new rules. In particular, orthopedic devices that were either based on equivalence and/or do not have their own clinical data over their expected lifetime will not have a possibility to be certified following the new rules in Europe. During this workshop TÜV SÜD experts will present you the new European requirements and discuss with you the pros and cons of the new system for both already approved and new planned certification in Europe.
Who should attend:
This event will benefit Regulatory Affairs and Quality Assurance staff from medical device manufacturing companies. The event will focus on implantable medical devices; and especially orthopedic devices and devices in contact with the spinal column.
About the speakers:
Dr. Basil Akra
Global Director – Clinical Focus Team
Clinical Centre of Excellence
Dr. Bassil Akra is the global director of the clinical centre of excellence at TÜV SÜD Product Service. Dr. Akra has long experience in research, development, quality management and regulatory approval of medical devices, combination devices and ATMP products. Dr. Akra is leading various consultation processes of medical devices incorporating an ancillary medicinal substance with the different competent authorities designated by the Member States or the EMA. He is presenting worldwide as a senior field expert the requirements in Europe and is involved in the development of several European guidance documents and standards. He is member of the Europe-an Clinical Investigation and Evaluation working group and is representing team NB and NB MED in several European discussions regarding the clinical requirements such as MEDDEV and other Guidance Documents on Innovative Devices.
CV, Ass. Prof. Gerold Labek, M.D.
Ass. Prof. Gerold Labek, M.D.
Clinical Centre of Excellence
Dr. Gerold Labek is member of the Clinical Centre of Excellence at TÜV SÜD Product Service. Dr. Labek is trained orthopedic surgeon, specialized on joint replacement. He has done his habilitation on research methodology, particularly on real world evidence, routine and register data and the reliability of clinical data from all sources. Dr. Labek has supported the development of joint replacement registries all over the world for 15 years. He is expert member of the European Commissions Clinical Investigation and Evaluation working group and in working groups revising MEDDEV guidance documents like MEDDEV 2.7.1. Dr. Labek is member of the IMDRF-registry working group harmonizing regulatory standards concerning real world evidence clinical data on a global scale.
Dr. Matthias Fink
Clinical Reviewer, Clinical Centre of Excellence
TÜV SÜD Product Service
Dr. Matthias Fink is a Clinical Reviewer for the CE certification under the European Medical Device Directives for mainly orthopedic medical devices in the Clinical Centre of Excellence of TÜV SÜD. Dr. Fink has expert knowledge in the field of orthopedic implants and cardiac devices and responsible for the leading of clinical teams within the department. He has the ability to build successful internal and external relationships enabling optimization and streamlining of operational clinical processes. Dr. Fink participated as investigator and co-investigator in national and international Phase III and IV clinical trials for medical device and pharmaceutical companies. He has profound medical and scientific knowledge with a broad understanding of musculoskeletal and degenerative diseases and the current standard of care.
Yuan Li, RAC, Ph.D.
Orthopedic Product Specialist / Auditor
TÜV SÜD Medical and Health Services
Dr. Li has been an Orthopedic Product Reviewer with 11+ years combined experience from Research and Regulatory Affairs, focused on biomechanics of human musculoskeletal system (i.e. spine, hip, knee and extremities). He is also a QMS/MDSAP auditor with auditing experience covering variety of device manufacturers. Dr. Li is a proven project/country manager with problem solving skills to complete projects (e.g. regulatory submissions and verification test) to the highest standard in a timely manner and an effective liaison between Product Development team and Competent Authorities with solid engineering understanding. Dr. Li is RAC (Global) certified Regulatory Affairs professional with knowledge to US, EU, Latin America, and Asia-Pacific regulations. He has eight peer-reviewed journal publications and five conference presentations on Biomedical Engineering field.