CE Mark: Content and Format for a Technical File and Design Dossier

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This presentation is intended to help you get familiar with the European Union (EU) Directives governing medical devices including in vitro diagnostic and active implantable medical devices.

This presentation is further intended to provide practical, actionable, and sustainable guidance on the regulatory requirements set out in the three directives (MDD, IV(M)DD, and AIMDD).

Understanding and accurate interpretation of the EU regulatory and quality requirements can significantly contribute to meeting the requirements and achieving compliance fast, leading to saving an enormous amount of your time, efforts and resources and resulting in bringing innovative medical products to the EU market faster.

This presentation will offer you great opportunities to learn about three directives (MDD, IVDD and AIMDD) and regulatory requirements including postmarket requirements and compliance. At the end of the presentation, you will get familiarized with the applicable EU directives governing medical devices including in-vitro diagnostic and active implantable medical devices, helping you implement regulatory requirements smooth and fast.

Areas to be Covered:

How EU laws are made
Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
CE Marking Principles
Device Classification
Medical Device Directive (MDD)
In Vitro Diagnostic Device Directive (IV(M)DD)
Active Implantable Medical Device Directive (AIMDD)
2007/47/EC Amending MDD and AIMDD
Globally Harmonized Technical File And Design Dossier
Declaration of Conformity
Clinical Evaluation
Postmarket Requirements: Surveillance and Vigilance
Harmonized Standards
EN ISO 14971:2012, EN ISO 13485:2012, and ISO 14155
MEDDEV Guidance Documents
Update on the EU Regulatory Scheme
Good Practices
Speaker’s PASS-IT Suggestion/Recommendations

Who will Benefit:

Compliance Officers
Complainant Managers
Managers (RA, QA/QC, CA)
Contractors and Subcontractors

Dr. David Lim

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, 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 eight 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 pharmacovigilance, medical device reporting, recalls and patient safety signals being conducted at the Regulatory Doctor. Dr. Lim currently serves as a member of the Advisory Board for Inspection Insider published by FDA News.

This product is currently out of stock and unavailable.

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  • Presentation Handout in .pdf format
  • Presentation from the Speaker
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  • Recording access Information with Password to view the webinar, will be sent 24 hours after the completion of the Live webinar.
  • Presentation Handout in .pdf format
  • Certificate of Attendance