What You Should Know About MDR Best Practices, Including PMCF
The Medical Device Regulation (MDR) 745/2017, published in 2017, established a stricter and more uniform regulatory framework for the European Union with the goal of improving the clinical safety of the devices. Today, all medical devices in Europe must comply with the MDR yet many companies are still facing difficulties navigating these new regulations.
In this webinar, we review major changes introduced by the MDR. We focus on the post-market requirements, especially the Post-Market Clinical Follow-up (PMCF). Our panel of experts also shares their experiences with the new MDR regulation and offer best practices for companies in the middle of, or about to start, their own MDR journey.
We can help you navigate PMCF across the entire lifecycle of your MedTech products.
Anagha KarnikDirector, Regulatory Affairs, Edwards Lifesciences Anagha has extensive experience in the medical device industry with a proven track record building strong regulatory affairs teams for product development and sustaining manufacturing of Class II and Class III medical devices including cardiovascular, endovascular, IVDs, polymers and has been responsible for bringing several devices to market. Her regulatory experience covers EFS IDEs, pivotal IDEs, Modular PMAs, 510(k)s, CE Marking - MDD Design Dossiers, Technical Files, MDR Technical Documentation (TD), International Dossiers, Clinical Evaluation Reports (CERs), Ad/Promo reviews, product claims/substantiation and market adoption strategies as well as successful domestic and international regulatory authority(ies) interactions and negotiations.
Arthi ChandranDivisional Vice President, Health Economics and Reimbursement, Abbott Arthi has been a leader in both US and Global roles and is focused on driving public health outcomes while delivering commercial growth in highly competitive markets. In her 15+ year career, in the Medtech and Pharmaceutical industries, Arthi has been recognized for embedding a practice of value demonstration and communication through differentiated evidence generation strategies and accompanying economic tools. She has championed, and continues to drive the proliferation of, cross-functional approaches to innovation and market development to secure broader access to, and adoption of, health care technologies.
Arthi holds an MPH in Chronic Disease Epidemiology from Yale University, an MS in Regulatory Affairs from Temple University and a Doctorate in Health Policy and Management from the City University of New York.