The CE Mark: Understanding the Medical Device Directives
Les Schnoll, Principal of Quality Docs, LLC
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Since 1995, the European Union has implemented several directives relating to medical devices. The three current directives (Medical Device Directive, Active Implantable Medical Device Directive, and In-Vitro Diagnostic Directive) have evolved and have led to a considerable amount of confusion by EU Member States, EU regulatory agencies, and medical device manufacturers. Even now, there are ongoing discussions to amend the existing directives; unfortunately, EU Member States cannot agree on the regulations that are currently in place.
This seminar on CE marking of devices will review the evolution of the medical device directives, their content, inconsistencies, enforcement, and proposed changes. Similarities and differences between the directives and the Quality System Regulation will also be discussed.
Upon completing this course on CE marking for medical devices participants will:
- Understand the current medical device directives
- Learn the evolution of and the reasons for the medical device directives
- Be able to determine the appropriate directive(s) for distributing product in the European Union
- Obtain a basic knowledge of structure of the three directives for medical devices
- Understand the correct use of the CE Mark
- Be able to determine how to correctly classify their medical device
- Understand the role of the notified body and competent authority
- Understand the various routes of conformity assessment
- Review proposed changes to the medical device directives and the timing of those changes
Who will Benefit:
This course is designed for personnel responsible for ensuring compliance with medical device regulatory requirements in the European Union. The following personnel will benefit from the course:
- Quality Managers and Professionals
- Regulatory Managers and Professionals
- Compliance Managers and Professionals
- Materials Management Managers and Professionals
- Sales and Marketing Managers and Professionals
- Legal Professionals
- Executive Management
|Day One (8:30 AM – 4:00 PM)
||Day Two (8:30 AM – 12:00 PM)
Registration Process: 8:30 AM – 9:00 AM
Session Start Time: 9:00 AM
Introduction to and Overview of the Medical Device Directives: This session will provide a high level overview of the EU regulations and give participants with the information necessary to understand and comply with the requirements.".
The Medical Device Directive
- Conformity Assessment
- The Essential Requirements
- Medical Device Classification
- The CE Mark and its Use
- Notified Bodies
- Competent Authorities
The Active Implantable Medical Device Directive
- The In-Vitro Diagnostic Directive
- Proposed Changes/Timing to the Medical Device Directives
- Review and Wrap-Up
Meet Your Instructor
Principal of Quality Docs, LLC
Les Schnoll has extensive experience in quality assurance, quality control, auditing, regulatory compliance, management, and microbiology in the medical device, pharmaceutical, and clinical/pre-clinical industries. Mr. Schnoll is recognized for achievements in developing value-added quality management and regulatory compliance systems. He is recognized by the Medicines and Healthcare Products Regulatory Agency (MHRA) (formerly the Medical Devices Authority) in the United Kingdom to perform assessments to the European Union Medical Device Directive and the European sterilization standards.
Les is the Principal of Quality Docs, LLC, providing quality and regulatory services to the FDA-regulated and Arizona Department of Health-regulated industries. He is also currently an Instructor in the Master of Science in Regulatory Affairs for Drugs, Biologics, and Medical Device program in the College of Professional Studies at Northeastern University and a Faculty Associate at Arizona State University, College of Nursing and Health Innovation, in the MS Regulatory Science and Health Safety Program. He was most recently the Vice President, Quality Assurance and Regulatory Affairs with the J.T. Posey Company and has held executive positions at ThermoGenesis, Theravance, Solectron, Hill-Rom, Gliatech, Cyberonics, Southern Research Institute, KPMG Quality Registrar, and Dow Corning Corporation. Les has conducted various training programs, audits, and systems development in the United States, Canada, Europe, South America, Russia, Australia, and the Pacific Rim.
Les has written articles for such publications as Medical Design and Material, ISO 9000 Handbook of Quality Standards and Compliance, Pharmaceutical and Medical Packaging News, Food Quality, and Quality Progress. He is also the author of The CE Mark: Understanding the Medical Device Directives and The Regulatory Compliance Almanac, published by Paton Press.
Les professional affiliations include the American Society for Quality as a Certified Quality Engineer, Certified Quality Auditor, and Certified Quality Manager; the Regulatory Affairs Professionals Society as Regulatory Affairs Certified; the Institute of Certified Quality Consultants as a Certified Quality Consultant; the American Society for Microbiology as a Registered Microbiologist (clinical microbiology) and Specialist Microbiologist (consumer and industrial microbiology); and the International Register of Certified Auditors as a certified lead assessor. He is a Fellow of the Chartered Quality Institute (formerly the Institute of Quality Assurance) and is accredited as a Chartered Quality Professional. Schnoll is also a former member of the United States Technical Advisory Group to Technical Committee 176, International Organization for Standardization and the United States Technical Advisory Group to Technical Committee 210, International Organization for Standardization.
Les has a Bachelor of Science degree in biology from Ursinus College, a Master of Science degree in microbiology from Villanova University, a Master of Business Administration in human resources from Central Michigan University, and a Juris Doctor in health law from Concord University School of Law.
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