Document the Clinical Evaluation Report (CER) for the EU MDR and CE Mark

Description:

This webinar will examine the key elements of the CER - The body of the CER consists of: 1) a description of the state-of-the-art, defined as the ‘Developed stage of current technical capability and/or accepted clinical practice in regard to products, processes, and patient management, based on the relevant consolidated findings of science, technology, and experience’, and 'what is currently and generally accepted as good practice in technology and medicine... [it] does not necessarily imply the most technologically advanced solution.' (International Medical Device Regulators Forum (IMDRF)): and 2) a comprehensive analysis of pre clinical data and pre- and post-market clinical data relevant to the device. All data sets should be documented, adequately analyzed, evaluated, summarized, and referenced in the CER.

Why Should You Attend:

This webinar will discuss the Clinical Evaluation Report (CER). The CER contains proven data to show that the device performs as intended without exposure to unacceptable risks to both users and patients. The CER should comply with strict regulatory guidelines (EU MDR 2017/745 and MEDDEV 2.7/1 version 4). In the EU Medical Device Regulation (MDR), no specifications on the CER or its table of contents are given. However, guidance on the CER outline is provided in Appendix A9 of MEDDEV 2.7/1 Rev 4, "Clinical evaluation: Guide for manufacturers and notified bodies". The CER contains a collection of research material and peer-review journal articles and similar clinical data demonstrating the safety of effectiveness of a medical device. The CER is part of a device's Technical Documentation File, and is one of several key documents involved in proof of meeting the applicable requirements of the EU MDR and in obtaining and retaining a device's CE mark. The CER contains a collection of clinical evidence for the safety, performance, and usability of a device. It shows that the device performs as intended without exposure to unacceptable risks to both users and patients. It can include applicable peer reviewed technical articles. It defines the medical condition or disease, and patient population being treated. It evaluates currently available treatment options including by approved benchmark devices, both their pros and cons. The literature review that was performed is documented in a Literature Search Plan and Report, and discusses both favorable and unfavorable information about the device.

Areas Covered in the Webinar:

• What Is a CER?

• EU MDR and MEDDEV Requirements

• Important areas to be considered / documented in the CER
• Types of clinical sources to be referenced / included
• Two key components
• What is meant by "state-of-the-art", and what is not
• What constitutes a comprehensive clinical data search? How documented?

Who Will Benefit:

• Senior management in Devices, Combination Products
• QA / RA
• Medical Device product development teams
• R&D
• Engineering
• Production
• Operations
• Marketing
• Consultants; others tasked with device QA, product development, manufacturing, process / product / data analysis, regulatory submission responsibilities

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 41 years experience in U.S. FDA-regulated industries, 27 years as head of his own consulting company. John has worked with companies from start-up to Fortune 100, in the U.S., Mexico, Canada, France, Germany, Sweden, China and Taiwan. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, new / changed product 510(k)s, process / product / equipment including QMS and software validations, ISO 14971 product risk management files / reports, Design Control / Design History Files, Technical Files. He's held positions in Manufacturing Engineering, QA, QAE, Regulatory Affairs, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, 5 chapters in the RAPS textbook on validation, conducted workshops and webinars worldwide on CGMP subjects. John is a graduate of UCLA.

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