What is the IVDR transition timeline?

The IVDR transition timeline refers to the phased deadlines set under Regulation (EU) 2017/746 for transitioning from IVDD to IVDR. These deadlines vary based on device classification, with final transition dates extending up to 2029.

When did IVDR come into force?

IVDR officially came into force on 26 May 2022, replacing the previous IVDD framework with stricter regulatory requirements for in vitro diagnostic devices in the EU.

What deadlines have already passed under IVDR?

Key deadlines such as QMS implementation and Notified Body application submission for IVDD-certified and Class D devices (May 2025) have already passed. Manufacturers who missed these may face compliance challenges.

What happens if manufacturers miss IVDR deadlines?

Missing IVDR deadlines can result in loss of market access in the EU, delays in certification, and potential supply disruptions for medical devices.

What are the key requirements for IVDR compliance?

Key requirements include: Implementing an IVDR-compliant QMS Preparing technical documentation Conducting performance evaluation Engaging with a Notified Body