What you need to know about your "at-risk" CERs
Sponsored by: Covance
- Council Directive
Date: 9 May
Days to go: 17
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 the required content and suggested format of Clinical Evaluation Reports (CERs). The revision was written to address the requirements of the Medical Device Directives (MDD) and the anticipated requirements of the Medical Device Regulation (MDR). Additionally, it focuses attention on the requirement that all technical documentation (Technical Files or Technical Dossiers) supporting a CE Mark requires a compliant CER.
Due to some of these changes, several device manufacturers with existing devices on the market have lost their CE Mark, incurring significant financial losses and spending more resources to receive a new CE Mark. Don't let this happen to you!
This webinar will discuss practical approaches to producing rev. 4 compliant CERs, and some of the procedural updates that should be considered as the MDR replaces the MDD in 2020. The webinar will also present some empirical case studies, providing examples of how Covance was able to help clients successfully address CER non-conformities.
Mary Beth Henderson, MBA, PhD,
Mary is VP of Regulatory Affairs and Quality Systems and a Senior Principal Advisor at RCRI, Inc. She has worked for over 30 years in medical device and biotechnology industries. She brings experience in strategic regulatory, quality, R&D, and business development roles to her project work. As a Senior Principal Advisor for RCRI, Mary has worked with clients to develop domestic and international regulatory strategies, draft submissions, and negotiate their approval by FDA and/or other regulatory
agencies. Leveraging her years of R&D and product development experience, Mary often works with product development teams or early-stage companies during initial phases of product design to provide regulatory support and guidance. Her chemistry and biotechnology expertise help to efficiently support project involving combination products or medical devices incorporating biological materials.
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
- Clinical Managers
- Regulatory Managers
- Medical Writers
- Portfolio Managers
- Chief Medical Officers