The New EU MDR and What It Means for Medical Devices

With the transition end date from the European Medical Device Directives (MDD 93/42/EC and MDD 90/385/EEC) to the new European Medical Device Regulations (EU MDR 2017/745) approaching on May 26, 2020, we are less than a year away from the most significant change in European medical device regulations since the 1990s.

EU MDR brings several highly impactful changes, noteworthy whether you are a small or large medical device developer, manufacturer, supplier, contract research organization (CRO), or notified body. For example, the fact that EU MDR is a regulation, not a directive, means it has binding legal force throughout all EU member states. Failure to meet compliance requirements could now have more costly legal repercussions.

EU MDR emphasizes patient safety, stipulating greater transparency, traceability and clinical evidence in support of product safety and efficacy claims. It focuses on the product life cycle, which is evident in the major categories of change, including the European Data Bank on Medical Devices (EUDAMED), supply chain, clinical evidence and investigations, post-market surveillance, and notified bodies responsibilities.

Join this free webinar to gain insights into requirement shifts surrounding clinical evaluations and data. Whether you’ve been long planning for EU MDR or taking the ‘wait and see’ approach, stay informed of the latest developments in interpretation, guidance and timelines. Get best practices on how to plan for EU MDR, and discover what options clinical research organizations have. Attendees will learn:

• Why and how the new EU MDR regulations came about
• How to take appropriate steps to ensure you’re prepared
• About EU MDR’s emphasis on clinical evaluations and investigations – and why this matters
• Why EU MDR necessitates eClinical platforms that boost efficiency, accuracy and compliance

Speaker

Verna Manty Rodriguez, Founder and Principal, Manty Medtech, Adjunct Lecturer, Bioengineering Department, Santa Clara University

Verna Rodriguez has over 35 years of experience in medical device design, development, quality and manufacturing. In 2018, she founded Manty Medtech which provides product development and design control consulting services to the medical device industry. In addition, she teaches design control for medical devices in the bioengineering department at Santa Clara University. She received her Bachelor of Science in Mechanical Engineering and Materials Science from UC Berkeley. Before embarking on consulting and teaching, Verna spent the previous six years as senior R&D director at PneumRx, Inc., a Bay Area start-up where she focused on leading the engineering team to develop a nitinol (nickel-titanium) implant for treating patients with severe emphysema. PneumRx was successfully acquired by BTG plc in 2015 for $475M. Prior to that, she led engineering teams at Boston Scientific and Guidant Corp. (now Abbott Vascular) for development of various cardiovascular devices including stents, grafts, balloon and ablation catheters and delivery systems. Her expertise includes design control, root cause analysis, risk management and process validation, and she has special interest in the application of nitinol and its superelastic properties to medical devices.

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