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Complimentary Webinar
September 21, 2021 | 11:00 a.m. - 12:00 p.m. ET
Increased EU Clinical Requirements
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The Medical Device Regulation 2017/745 introduced higher pre- and post-market clinical requirements on manufacturers of all classes of devices. Class III and Implantable devices are required to conduct clinical investigations and just in some exemptional cases allowed to justify the reliance on existent sufficient clinical data. Non-implantable class IIa and IIb devices must fulfill higher requirements to be able to use the equivalence approach when justifying safety and performance of a device. All devices are obliged to conduct PMCF which is divided into general and specific activities including also activities related to similar or equivalent devices. All these requirements remain challenging for the various stakeholders due to the missing experience in their implementation. During this webinar we will be able to share with you the first experience with the implementation of the regulatory requirements and the feedback of a designated notified body on the first submissions according to the new legislation.
SPEAKERS
Robert Dostert
Sales Manager Medical Devices
DNV
Robert has 20 years of experience in the Healthcare industry. At DNV, Robert collaborates with a team of more than 150 experts, who serve the medical device industry worldwide. Robert is driven to ensure DNV's clients are provided quality services including assessments, CE Marking, software tools, training, and technical expertise to successfully bring their products to the healthcare market in a safe and timely manner.
Dr. Bassil Akra
CEO & Owner
AKRA TEAM GmbH
Dr. Akra is a regulatory expert supporting his clients in the field of medical device, in-vitro diagnostic, and combination devices. He has long experience in leadership, business management, research, development, quality management, and regulatory approval of medical devices, combination devices, and ATMP Products. 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. He was also involved in the drafting of several European guidance documents (e.g. MEDDEV, MDCG, etc.) and International Standards.
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