IVDR: What Does It Mean for Manufacturers of In Vitro Diagnostic Devices?

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The In Vitro Diagnostic Medical Devices Directive 98/79/EC (IVDD) guided the market of in vitro diagnostic devices for more than 20 years. However, it officially ended in May 2022 its effectiveness, giving way to the In Vitro Diagnostic Regulation (IVDR). Many manufacturers have found themselves unprepared for the changes, facing narrow deadlines and new, stricter requirements. 

Deadlines for Transitioning to IVDR 

Under the original rules, manufacturers had to switch from IVDD to IVDR of self-declared IVDs by the following dates:       

• May 26, 2025, for Class D devices, 
• May 26, 2026, for Class C devices, 
• May 26, 2027, for Class B devices, 
• May 26, 2027, for Class A devices that are sold under sterile conditions.

For Class A devices that are not sterile, IVDR became mandatory from May 26, 2022, with no transition period. 

IVDR Amendments: Regulation 1860/2024/EU 

In 2024, Regulation 1860/2024/EU introduced important changes. The main purpose of this regulation was to give manufacturers and notified bodies more time to adjust the passages from IVDD to IVDR.  

The new deadlines for the passage of self-declared IVDs from IVDD to IVDR are:

• December 31, 2027 for Class D devices,
• December 31, 2028 for Class C devices, 
• December 31, 2029 for Class B and Class A (sterile) devices.