IVD Directive (IVDD) to IVD Regulation (IVDR) Transition Training Course

There are significant changes in the European legislation applicable to IVDs. The IVDR (In Vitro Diagnostic Regulation) (EU 2017/746) has replaced the IVD Directive (98/79/EC), and will impose new requirements on manufacturers and other Economic Operators.

This long awaited text brings a number of significant changes to the regulatory requirements for IVD manufacturers, addressing the challenges posed by the IVD Directive. The changes include a new rule-based classification system, increased scrutiny of technical documentation, and improved traceability of devices through the supply chain.

Our one day training course has been designed to introduce IVD manufacturers and other Economic Operators in the supply chain to the key changes to requirements for CE marking following the publication of the new IVD Regulation (IVDR).

How will I benefit?

This course will help you:

  • Identify the requirements of the new IVD Regulation and how this will impact your organization and other operators
  • Understand the significant changes that are being introduced by the new legislation
  • Learn what needs to be revised in your current arrangements to meet compliance
  • Take steps to ensure that existing products CE marked under the IVD Directive comply with the new regulation
  • Create a plan for your organization to transition to the new regulation for new IVD product development