In Vitro Diagnostic Regulation

The IVDR replaced the IVDD and entered into force on 26 May 2017 with 26 May 2022 as date of application. On March 2023, the IVDR was amended as regards to transitional provisions for certain in vitro diagnostic (IVD) medical devices on Article 110(4) with the removal of the sell-off period to prevent unnecessary disposal of safe in vitro diagnostic medical devices that are still in the supply chain by means of (EU) 2023/607. On 9 July 2024 (EU) 2024/1860 has been published in the Official Journal of the European Commission and amends and further extends the transitional periods laid down in the IVD Regulation.

Only legacy devices, meaning devices covered by a certificate issued by 26^th May 2022 or declaration of conformity drawn up before 26 May 2022 under the IVD Directive, and considered valid by virtue of Article 110 3a and 3b, may benefit from the extended transition period if:

• The device continues to comply with IVDD requirements.
• There are no significant changes in design or intended purpose or the device.
• The device does not present an unacceptable risk to the health and safety of patient.
• The manufacturer has implemented an IVDR compliant QMS no later than 25 May 2025
• Depending on the risk class of the device, the manufacturer has lodged a formal application with a NB by May 2025 for IVDD certified devices and Class D devices that were self-declared under the IVDD, by May 2026 for Class C self-declared IVDs and by May 2027 for class B and A-Sterile self-declared IVDs.
• Depending on the risk class of the device, the manufacturer has signed a written agreement with a NB by September 2025 for IVDD certified devices and Class D devices that were self-declared under the IVDD, by September 2026 for Class C self-declared IVDs and by September 2027 for class B and A-Sterile self-declared IVDs.

If the above requirements are fulfilled, depending on the risk class of the device, the transition period is extended to:

• 31 December 2027 for IVDD certified devices and Class D self-declared devices .
• 31 December 2028 for Class C self-declared devices.
• 31 December 2029 for Class B and A-Sterile self-declared devices.