051 - "EU MDR" with Bassil Akra

Combinate Podcast - Quality in Pharma and Medical Devices

On this episode, I was joined by Bassil Akra, the CEO of AKRA Team. Bassil and I discuss:

• EU MDR and Implementation Timeframe
• Notified Bodies, Competent Authorities, MOH's and the EU Commission
• Article 117 & Drug/Device Combination Products
• Differences between MDD and MDR for Economic Operators
• His Favorite Book: EU MDR

Dr. Bassil Akra spent the last year supporting medical device, in-vitro diagnostic, combination device companies preparing their strategy for the EU regulations MDR 2017/745 and IVDR 2017/746. Before that, he spent many years as a subject matter expert at the biggest notified body in Europe acting in the various roles and representing locally and globally the notified body association in the various European discussion and guidance documents preparation. Dr. Akra was the Vice President of Strategic Business Development at the Global Medical Health Services of TÜV SÜD Product Service GmbH. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. Dr. Akra played an essential role during the implementation of the medical device regulation in Europe. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standard. He spent the last years of his career at TÜV SÜD training and educating the various stakeholders on the EU Legislations (e.g. MDD/AIMDD, MDR and IVDR), supporting their implementation towards achieving the relevant designation ensuring continuity of the healthcare system in the interest of the patient population.