Date/TimeMarch 24, 2022
With the EU Medical Device Regulation (MDR) now fully applicable, manufacturers are facing the challenges of both transitioning legacy devices to the MDR, and introducing new products. Although the 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 MDR, there is substantial pressure to make MDR submissions as soon as possible to avoid the “cliff edge” of May 2024.
A few examples of the clinical and regulatory challenges include:
- Strategies for Post-Market Clinical Follow-up (PMCF) and implementation of those activities
- New clinical investigation submissions
- Presentation of clinical data within the MDCG and MEDDEV framework.
NAMSA invites you to view this webinar as our team of regulatory experts discuss practical insights to address these challenges.
Attendees can expect to gain a better understanding of:
- Increased clinical data requirements under the EU MDR, particularly in relation to PMCF
- How to define and plan appropriate strategies to meet requirements under the EU MDR
- NAMSA experiences with multiple manufacturers and Notified Bodies
- Challenges faced by other manufacturers and proposed solutions
- Carefully planned MDR submissions
Adrian Keene, BSc (Hons)Associate Vice President of Global Biological Safety & Validation and EMEA Consulting Services
Adrian has more than 30 years of experience in product development and registration within the medical device industry, with manufacturer, regulatory agency, and consultancy perspectives. Adrian’s knowledge of new product development combined with EU regulatory requirements enables him to provide a balanced and pragmatic interpretation of the needs and expectations of both regulators and manufacturers. His current responsibilities at NAMSA are leading both the global biological safety and validation teams and the EMEA regulatory teams.
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 under the Medical Device Directive (MDD). He is a toxicologist by training and worked for several years in the medical device industry in Research and Development, providing toxicological and risk management strategies to expedite product launches for multiple global registrations.
He attended the School of Pharmacy at the University of London following and conducted postgraduate research in “Retinoid-Induced Skeletal Toxicity.” He also holds a diploma in “Managing Medical Product Innovation” from the Scandinavian International Management Institute.
Jane Arnold-RoundPrincipal Regulatory Consultant
Jane Arnold-Round has over 25 years of experience in the medical device industry, working with a broad range of medical device technologies and organizations from start-ups to multinationals. She worked as a Notified Body reviewer for over 15 years at BSI as a Medical Device Product Specialist with particular responsibility in the wound-care sector. Prior to joining NAMSA in 2018, she was a Regulatory Consultant for 14 years. Jane’s current focus involves complex submissions for high-risk devices, including development of regulatory and clinical strategies, design dossier and technical file compilations, device-drug consultations, clinical evaluations and regulatory due diligence.
Sara FinocchiettiSenior Clinical Study Manager
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 industry. She has been working with a wide range of organizations, from start-ups, SMEs and public research entities, bringing innovative products to market or supporting existing portfolios. She was notably Clinical Affairs Manager in 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 Degree in Biomedical Engineering from Italy and a PhD in Clinical Science from Denmark.