What is the in vitro diagnostic medical devices regulation IVDR (EU) 2017/746? When does it apply?

The in Vitro Diagnostic Medical Devices Regulation(EU) 2017/746 IVDR rules the in Vitro Diagnostic Medical Devices marketing, provision, and commissioning on the European market. IVDR was published on 5th May 2017 and became effective on 26th May 2017, replacing the EU Directive 98/79/EC on in Vitro Diagnostic Medical Devices.

The IVDR (EU) 2017/746 Regulation full application was planned for 26th May 2022, but after delays and difficulties in the field, amplified by Covid-19 pandemic consequences, the Council of the EU and the European Parliament – through an amendment published on 15th December 2021 – edited timings and authorised a gradual introduction for IVDR (EU) 2017/746 Regulation.

New transition periods have been established for the Regulation application based on IVD Devices risk class.

In this way many industry operators have more time to comply with the Regulation, the starting date of the full application stays the same (26th May 2022), as from class A non-sterile IVD Devices.

The next deadlines within which to adjust to IVDR (EU) 2017/746 are the following:

  • 26th May 2025 for higher risk devices (class D)
  • 26th May 2026 for class C devices
  • 26th May 2027 for class B devices and class A sterile devices.

For in Vitro Diagnostic Medical Devices CE-marked which do not require the involvement of a Notified Body, IVDR (EU) 2017/746 Regulation shall apply as from 26th May 2022.

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