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
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
Postmarket Requirements: Surveillance and Vigilance
EN ISO 14971:2012, EN ISO 13485:2012, and ISO 14155
MEDDEV Guidance Documents
Update on the EU Regulatory Scheme
Speaker’s PASS-IT Suggestion/Recommendations
Who will Benefit:
Managers (RA, QA/QC, CA)
Contractors and Subcontractors