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In Vitro Diagnostics

Enhancing patient access to clinical trials using in vitro diagnostics

In the European Union (EU), the In Vitro Diagnostic Medical Devices Regulation (IVDR) - adopted in April 2017 - sets out the regulatory framework for in vitro diagnostic medical devices. The Regulation covers, amongst other things, the placing on the market and making available on the market of in vitro diagnostic medical devices in the EU.

Key novelties of the new legislation include:

  • An increased involvement of independent conformity assessment bodies (or ‘notified bodies’);
  • A new risk classification system;
  • Reinforced provisions concerning conformity assessment procedures, performance evaluation and performance studies, vigilance and market surveillance;
  • A set of common rules for in-house devices (those manufactured and used in the same health institution);
  • New provisions ensuring transparency and traceability regarding in vitro diagnostic medical devices.

The IVDR entered into application on 26 May 2022 and it replaced the former Directive 98/79/EC on in vitro diagnostic medical devices.

Since the entry into application, various issues have occurred affecting the implementation of the new legislation. The coordinated process set out in the IVDR, as well as the required infrastructure and guidance, are currently not yet fully established. This situation is resulting in fragmented initiation processes for clinical trials using in vitro diagnostics, including clinical trials conducted in the oncology space.

ESMO has as such reached out to EU Health Commissioner Stella Kyriakides to address these issues and underline the need for concrete solutions. ESMO will continue to monitor the implementation of the IVDR and intends to work with all involved stakeholders on addressing any negative impact on oncology trials.

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