Clinical Challenges under the EU MDR

With the European Union (EU) Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the EU MDR, and introducing new products. Although Medical Device Coordination Group (MDCG) guidance has been forthcoming, there remain significant gaps in guidance and interpretation of requirements, and varying interpretations of expectations. In addition with the limited number of notified bodies designated under the EU MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024.

The clinical and regulatory challenges are broad and include: strategies for post-market clinical follow-up (PMCF) and implementation of those activities, making new clinical investigation submissions, and presentation of clinical data within the MDCG and Medical Devices Documents (MEDDEV) framework, to name but a few.

Manufacturers need to utilise multidisciplinary teams to address these challenges.

Join this webinar as NAMSA brings together expertise from multiple domains of the EU MDR, to provide practical insights as well as an extended Q&A session.

Speakers

Adrian Keene, BSc (Hons), Senior Director, Global Biological Safety and Validation and EMEA Consulting Services, NAMSA

With 29 years of experience in the medical device industry, Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced interpretation of the needs and expectations of Notified Bodies, competent authorities and manufacturers. His current responsibilities at NAMSA involve leading the regulatory, quality and biological evaluation teams — working with a broad range of devices including drug-device combination products.

Prior to working at NAMSA, Adrian was Head of Notified Body for the UK Notified Body SGS, and spent 10 years in the notified body sector, where he was responsible for conformity assessment activities of high risk (class III) devices. He is a toxicologist by training and worked for a number of years in the medical device industry in research and development, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.

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Jane Arnold-Round, Principal Regulatory Scientist, NAMSA

Jane Arnold-Round has 30 years of experience in the medical device industry working with a broad range of medical device technologies and organizations from start-ups to multinationals.

Jane began her career with Medtronic and then Sulzer Vascutek before joining BSI in 2000 where responsibilities included conducting Product Conformity Assessments against the requirements of the European Directive 93/42/EEC. While at BSI, her time was dedicated to products utilizing animal tissues, device-drug combination devices and high-risk wound care products. Following these positions, Jane joined NAMSA in regulatory consulting where she focuses on partnering with manufacturers of high-risk, Class III devices to achieve regulatory approval.

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Sara Finocchietti, Senior Clinical Study Manager, NAMSA

Sara Finocchietti serves as Senior Clinical Study Manager at NAMSA, managing both pre- and post-market studies. She has over 10 years’ experience in clinical affairs and management in the medical device domain. She has been working with a wide range of organisations, from start-ups, SMEs, and public research entities, bringing innovative products to market or supporting existing portfolios. She was notably Clinical Affairs Manager for a French orthopaedic manufacturer, responsible of the company’s clinical strategy and study management.

Sara has extensive experience of working within cross-functional and cross-cultural teams. She holds a master’s degree in Biomedical Engineering from Italy and a PhD in Clinical Science from Denmark.

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