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IVDR – In-Vitro Medical Devices Regulation

Conducted by: Dr. Anja Wiersma
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The current Covid-19 pandemic showed the huge importance of good, safe and well performing In Vitro Diagnostic (IVD) tests: DNA – polymerase Chain Reaction (PCR) testing vs antigen tests. Additionally, to the pandemic the in-vitro diagnostic (IVD) sector faces a significant challenge to plan for and comply with the new European IVD regulation (In Vitro Diagnostic Device Regulation (IVDR) EU...Continue reading

The current Covid-19 pandemic showed the huge importance of good, safe and well performing In Vitro Diagnostic (IVD) tests: DNA – polymerase Chain Reaction (PCR) testing vs antigen tests.
Additionally, to the pandemic the in-vitro diagnostic (IVD) sector faces a significant challenge to plan for and comply with the new European IVD regulation (In Vitro Diagnostic Device Regulation (IVDR) EU 2017/746) before 26 May 2022.
The transition from the current IVD Directive to meeting the new requirements involves significant preparation and data generation to be ready for additional notified body review and scrutiny.
It is vital that IVD manufacturers get started and ready to fully understand the requirements of the IVDR and calibrate how to meet the new expectations.
The shift from the current IVD Directive will involve a transition to the new requirements, which will require significant preparation and data generation before additional submission for circumstantial review.

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Dates: 
  • 22/11/2021
  • 23/11/2021
Course location: Zoom Course
Duration: 2 half-day Course (Evening)
Hours: 16:00 - 19:30
Credits: 1
Course Language: English

Course price: ₪1,700 + VAT
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Issues to be covered

  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?
  1. Meeting challenges for IVDR submissions at the Notified bodyà enough notified bodies?
  1. Eudamed and Unique Device Identifier (UDI) what is required and when?

Who should attend

  • 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

Benefits to the Participants

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

About The Lecturer

Anja Wiersma
Dr. Wiersma, is a medical biologist by training with a
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