Bassil Akra

Dr. Bassil Akra is the CEO and co-owner of QUNIQUE GmbH, a medical device and in-vitro diagnostic consultancy company, located in Germany and Switzerland. He spent the last decade as a subject matter expert at the biggest notified body in Europe and represented locally and the globally the notified body association in the various European discussion. Dr. Akra was the Vice President for strategic business development at the Global Medical Health Services of TÜV SÜD Product Service GmbH in Germany. 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 (MDR 2017/745) in Europe and was involved in the drafting of the several European guidance documents (e.g. MEDDEV, MDCG, etc.). 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) and their impact on the EU healthcare  system.

After 4 years of transition period followed by a pandemic year, we reached the date of application of the medical device regulation 2017/745 on May 26, 2021. A lot of uncertainty is still associated with this date and key stakeholders are still questioning the readiness of the system. Twenty notified bodies out of fifty applicants were already designated for this legislation, more than sixty guidance documents clarifying the wording of the regulation were published and partial implementation of EUDAMED was achieved, but is it enough to ensure smooth transition from the old directives to the new legislative framework? It is positive to see twenty designated notified bodies for this legislation that are committed to support its implementation by continuously hiring and training new resources ensuring sufficient capacity for the various scopes necessary. Nevertheless, we should not forget that more than 80 notified bodies were available in 2012 and the system was not able to deliver predictable assessment and certification decisions. With the requirement for initial certification of all devices regardless of their market history, the prerequisites written in Article 120 and especially the expectation on notified bodies to apply appropriate surveillance ensuring continuous compliance of directives´ certificates during the grace period of the regulation from May 2021 till May 2024 it remains questionable if the current capacity will be sufficient. Therefore, it is key to start applying practical and reasonable interpretation avoiding additional burden on the notified bodies who are struggling to keep on track with the continuous changes and implement the requirements in a timely manner. Also positive is the publication of the huge number of guidance documents supporting notified bodies and manufacturers implementing the requirements. Nevertheless, we still miss key guidance documents and common specifications which are essential for the implementation of the regulation (e.g. appropriate surveillance, article...