1. CE Marking: MDD, AIMDD and IVDD- Online Compliance Panel
Description:
This webinar 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 webinar is
further intended to provide guidance on the regulatory requirements set out in the applicable
Directives, which help assure that medical devices are safe and effective for their intended use.
Understanding the EU regulatory and quality requirements can significantly contribute to meeting the
requirements and achieving compliance fast, resulting in saving significant amount of time, efforts and
resources and bringing innovative medical products to the EU market faster. This webinar will discuss EU
Directives, requirements including postmarket requirements and compliance. At the end of the webinar,
you will get familiarized with the applicable EU Directives governing medical devices including in vitro
diagnostic and active implantable medical devices.
Objectives of the Presentation:
How EU laws are made
Overview of European Medical Device Regulations and Regulatory Framework for Medical Devices
Medical Device Directive (MDD)
Active Implantable Medical Device Directive (AIMDD)
In Vitro Diagnostic Device Directive (IVDD)
2007/47/EC Amending MDD and AIMDD
CE Marking Principles
Device Classification
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
IMDRF and GHTF

2. MEDDEV Guidance Documents
Who can Benefit:
CEOs
VPs
Compliance Officers
Attorneys
Complainant Managers
Managers (RA, QA/QC, CA)
Consultants
Contractors and Subcontractors
Live Session - How it works
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Recorded Session - How it works
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Presentation handouts will also be shared in pdf format.
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