What you need to know about your "at-risk" CERs
Sponsored by: Covance
- Council Directive
Date: 9 May
Days to go: 47
Time: 4PM London/11AM New York
Understanding and navigating the regulatory landscape for Clinical Evaluation Reports (CER)
The MEDDEV 2.7/1 revision 4 - CLINICAL EVALUATION: A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC, published in June 2016, presented significant changes in requirements to the previous (revision 3) version. The additional requirements for substantive literature and clinical trial data have posed increased challenges, especially for Class 2b and 3 device manufacturers; some of whom have even lost their CE Mark for existing devices on the market, incurring significant financial losses and more resources to receive a new CE Mark. In addition, REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of April 2017 (MDR), published in April 2017, presented a fundamental overhaul and amalgamation of requirements introduced in Council Directive 90/385/EEC and Council Directive93/42/EEC, and subsequent Directive 2007/47/EC amending the two. The new, stricter requirements of the MDR, combined with uncertainties surrounding the economic operators impacting the total product lifecycle of the device, have posed additional challenges to device manufacturers and sponsors.
This webinar will highlight the MDR, outline the changes in requirements for CERs from MEDDEV 2.7/1 revision 3 to revision 4, and demonstrate the process for effective CER development according to the stages prescribed in revision 4. Requirements in revision 4 were created not only to address gaps in the previous revision and incorporate changes introduced by Directive 2007/47/EC amending Council Directive 90/385/EEC and Council Directive93/42/EEC, but also to prepare medical device manufacturers to meet the requirements in the MDR. The webinar will also look at some empirical case studies, illustrating the pain points manufacturers experienced that were caused by the insufficiencies in the CER, providing examples of how Covance was able to help address these insufficiencies so the manufacturer could obtain a positive assessment by a notified body.
How’s your transition to your MDR going? Register today to gain new insights and tips on successfully navigating to the MDR.
Sr Director, Regulatory Affairs
Prithul started her career as a health informatics software developer 20 years ago. Prithul has served in business development, clinical research, protocol writing, clinical development planning and head of global regulatory affairs roles. Prithul is a Senior Director within Strategy Product Development, Global Regulatory Affairs specializing in medical devices and responds continually to requests for additional information by notified bodies. Prithul has served as a lead technical reviewer of premarket notifications for software medical devices. Biomedical and clinical informatics remain Prithul’s area of post graduate study and research at the Institute of Health Informatics, University of Minnesota
Lisa Moore, PhD,
Executive Director, Head, Medical Device and Diagnostic Solutions
Dr. Moore has a PhD in cardiovascular physiology and a degree in nursing. She has been a critical care and trauma nurse prior to beginning her career in clinical research. Her experience includes protocol and trial development, DSMB/CEC, regulatory submission support and management for more than 35 cardiovascular trials. She has experience in the following therapeutic areas: cardiovascular (stents, ablation, endovascular and valve), electrophysiology and arrhythmias, CNS, dermatology, infectious disease, oncology, transplant (solid organ), and women’s health. Dr. Moore is currently Global Head, Covance Device and Diagnostic Solutions business and a Research Professor, Florida Institute of Technology.
Key Learning Objectives
- Understand the new requirements in MEDDEV 2.7/1 revision 4 for CERs
- Know how to develop a CER that satisfies these requirements
- Understand how to address gaps, identified by a notified body, in a previously submitted CER
- Chief Medical Officers
- Heads of Research
- Regulatory Management