CE Marking: MDD, AIMDD and IVDD

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
60 Minutes
Product Description

Comprehensive Overview Of European Medical Device Regulations And Regulatory Framework For Medical Devices

Join David Lim in this 60-minute session to 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 insights into three directives (MDD, IVDD and AIMDD) and regulatory requirements including post-market 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.

Session Highlights:

  • 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
  • Technical File And Design Dossier
  • Declaration of Conformity
  • Clinical Evaluation
  • Post-market 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
  • Conclusion

Who should attend?

  • CEOs
  • VPs
  • Compliance Officers
  • Attorneys
  • Complainant Managers
  • Managers (RA, QA/QC, CA)
  • Consultants
  • Contractors and Subcontractors

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor (www.RegulatoryDoctor.us). As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
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