Key Information on European Commission’s Proposed Extension of IVDR Transition Period

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Tech News Summary:

  • The European Commission is proposing an extension to the deadline for implementing the In Vitro Diagnostic Medical Devices Regulation (IVDR) to ensure patient care and improve the availability of essential health products.
  • The proposed measures include giving manufacturers more time to implement new standards for in vitro diagnostics, accelerating the launch of the European database on medical devices (EUDAMED), and requiring advanced notice for discontinuing the supply of IVDs or medical devices.
  • The proposal will be presented to the European Parliament and Council for adoption, and MedTech Europe has welcomed these proposals, emphasizing the importance of successful practical implementation of EUDAMED and supporting action by stakeholders for effective changes.

The European Commission has proposed an extension to the transition period for the implementation of the In Vitro Diagnostic Medical Devices Regulation (IVDR). The proposed extension would give manufacturers an additional five years to comply with the new regulations, bringing the transition period to a total of 10 years.

The IVDR, which was adopted in 2017, is set to replace the current In Vitro Diagnostic Medical Devices Directive (IVDD) and will introduce stricter requirements for the approval and marketing of in vitro diagnostic medical devices in the European Union. The regulation aims to improve the safety and performance of these devices while also enhancing transparency and traceability.

The proposed extension comes in response to concerns from industry stakeholders about the tight timelines for compliance with the new regulations. The COVID-19 pandemic has also had an impact on the implementation of the IVDR, leading to delays in the preparation and certification of in vitro diagnostic devices.

The European Commission’s proposal to extend the transition period for the IVDR is subject to approval by the European Parliament and the Council of the European Union. If approved, the extended transition period would give manufacturers more time to ensure that their products comply with the new regulations and would help mitigate potential disruptions to the availability of in vitro diagnostic devices in the EU market.

Ultimately, the proposed extension aims to provide a smoother and more manageable transition to the new regulatory requirements, while ensuring the continued availability of safe and effective in vitro diagnostic medical devices for healthcare providers and patients across the European Union. Industry stakeholders are urged to stay informed about the latest developments and to prepare for the changes that will come with the implementation of the IVDR.

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