1. Impact of the timelines;
2. Key changes of the new regulation compared to the old directive (In Vitro Diagnostic Directive (IVDD) (98/79/EEC);
3. Understand the current state of knowledge for implementing the IVDR and what is still anticipated
4. Know how to classify your device and what conformity assessment routes can be followed
   1. Example: Covid-19 tests from self-declared to Highest risk class (Class D).
5. Economic operators’ requirementsà new economic operators under the IVDR
   1. Importer
   2. Distributor
   3. Person Responsible for Regulatory Requirements (PRRC)
6. Know the new Quality Management System (QMS) requirements and put them into operation
7. Best practices assembly of the Technical Documentation
8. Managing legacy products as “new” submissions; Technical Documentation and Clinical Evidence/ Performance evaluation
9. Post market Surveillance requirements: Post market surveillance plan (PMS plan), Periodic Safety Update report (PSUR), Summary of safety and Performance (SSP)m, what is needed?
10. Meeting challenges for IVDR submissions at the Notified bodyà enough notified bodies?

11. Eudamed and Unique Device Identifier (UDI) what is required and when?

• Quality Assurance (QA) Manager and or Regulatory Affairs (RA) Managers of IVD manufacturers
• QA/RA managers of IVD distributors/ sales organisations
• Design and development managers/ employees at IVD Manufacturers
• Sales and Marketing employees of IVD manufacturer and distributors

Understand the IVDR requirements and prepare for a smooth transition to enter the European market with the current and new In Vitro Diagnostic Medical Device Tests