IVDR Transitional Provisions: Timeline and Strategy Planning

The IVDR transitional provisions have been extended multiple times, providing manufacturers additional time for compliance. Understanding the current timeline is essential for strategic planning.

Key Dates Overview

The IVDR entered into force on May 26, 2017, with the date of application originally set for May 26, 2022. Extended transitional periods now apply:

• Class D devices: Transition deadline extended through May 2027
• Class C devices: Transition deadline extended through May 2028
• Class B and A (sterile): Transition deadline extended through May 2028

Legacy Devices

Devices lawfully placed on the market under IVDD may continue to be made available until their transitional deadline, provided:

• They comply with IVDD requirements
• No significant changes in design or intended purpose
• Vigilance and PMS requirements of IVDR are met
• An application to a Notified Body was submitted before the transition deadline

Strategic Planning Recommendations

• Prioritize higher-risk (Class D, C) devices in your transition planning
• Engage with Notified Bodies early - capacity is limited
• Assess your device portfolio for classification changes
• Begin technical documentation updates well in advance
• Implement IVDR-compliant QMS changes systematically

Notified Body Capacity

A limited number of Notified Bodies have been designated under IVDR. Plan ahead and initiate contact early to secure audit slots.

Documentation Updates

Use the transition period to systematically update your technical documentation to meet IVDR requirements, even if your deadline is further away.