This seminar is intended to help you get familiar with regulatory requirements for CE marking for medical devices in European Union (EU) including European Economic Area (EEA). In EU and EEA, medical devices are governed by three directives (medical devices, active implantable medical devices, and in vitro diagnostic medical devices (IVDs)). In particular, this seminar is further intended to discuss content and format for both a technical file (Summary Technical Documentation, STED) and design dossier for CE marking purposes in a PASS-IT manner*.
*It refers to "Practical, Actionable, and Sustainable Solutions or Strategy in an Integrated, Thorough" or ("PASS-IT") manner.
In this seminar, you will become familiar with how to put together a technical file or design dossier for CE marking for medical devices including IVDs. This seminar will help device firms save an enormous amount of time, efforts and resources, bringing medical products into the EU market faster.
- Applicable Laws, Regulations and Definitions
- Update on New Legislation, Current Trends and Impact
- Overview of Council Directives Concerning Medical Devices (MDD), Active Implantable Medical Devices (AIMDD), and In Vitro Diagnostic Medical Devices (IVDD)
- CE Mark Process: CAs, NBs and EU Databases
- Device Classification and Rules
- Essential Requirements
- Identifying Regulatory Requirements: Major Changes in 2014
- How to Meet the Essential Requirements
- Design Control
- Verification and/or Validation
- Risk Management to Better Meet the Essential Requirements in Addition to EN ISO 14971:2012
- EN ISO 13485:2012
- ISO 14155
- Quality Management Systems and Changes Effective for Own Brand Labelling
- Label, Labeling, and National Requirements
- Content and Format for a Technical File (STED)
- Contents and Format for a Design Dossier
- Integrating a Unique Device Identification (UDI) System with Improved Awareness
- Good Practices: Tips and Suggestions for Unannounced Audits
Dr David Lim,
President and Principal Consultant ,
Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor. Dr. Lim frequently presents global regulatory and quality compliance topics in various forums and meetings. Recently, Dr. Lim developed 510(k) templates ready for use compliant with e-Copy and RTA policy. In addition, Dr. Lim developed FDA inspection checklists for drug and medical device manufacturers based on his analysis of FDA inspectional observations cited in 483s for the past seven years. Dr. Lim provides his feedback to regulatory agency (e.g., US FDA) through public comments and also served as a panel member during the FDA’s transparency public meeting in 2009. Dr. Lim contributes to the Regulatory Affairs Professional Society (RAPS) as an author and speaker. Dr. Lim leads and directs all research projects including, but not limited to, pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor.