EU MDR & IVDR Submission Mastery

Description

Course Title: EU MDR & IVDR Submission Mastery

Description:

The EU MDR & IVDR Submission Mastery is a power-packed 3-hour  session covering all 8 critical modules — from regulatory foundations and classification strategy to clinical evaluation, EUDAMED registration, and notified body interaction. It is designed for professionals who need practical, actionable knowledge to achieve CE marking and maintain compliance with the EU Medical Device Regulation (MDR 2017/745) and In Vitro Diagnostic Regulation (IVDR 2017/746).

From classification strategy to notified body interaction, this session delivers a complete regulatory roadmap live, taught by industry experts with hands-on EU MDR/IVDR submission experience.

What You Will Learn:

• Master MDR (2017/745) and IVDR (2017/746) regulatory frameworks from the ground up
• Navigate device classification: MDR Annex VIII (22 rules) & IVDR Classes A–D
• Build complete Technical Documentation (Annex II/III) using the STED framework
• Write defensible Clinical Evaluation Reports (CER) and Performance Evaluation Reports (PER)
• Align QMS to ISO 13485:2016 and MDR Annex IX requirements
• Design robust Post-Market Surveillance (PMS) systems and PMCF plans
• Register actors and devices in EUDAMED; assign and label UDIs correctly
• Select the right Notified Body and manage the audit process confidently

Who Should Attend: Manufacturers, Regulatory Affairs professionals, R&D/QA teams, RA consultants, students/freshers building a regulatory career, and healthcare importers/distributors.