Class B IVDR planning starts before the final deadline
The transition end date is only one milestone in an eligible legacy device’s conformity-assessment plan.
The earlier milestones
For eligible self-declared IVDD legacy devices moving into class B under IVDR, the transition can run to 31 December 2029. The conditions include an IVDR quality management system by 26 May 2025, a formal notified-body application by 26 May 2027 and a written agreement by 26 September 2027. A device already covered by an IVDD notified-body certificate follows the applicable certified-device timeline instead.
Start with the device’s actual history
Classification alone does not establish transition eligibility. Check the original declaration or certificate, the product’s design and intended-purpose history, and whether the required conditions have been met. New devices cannot simply adopt a legacy-device timetable.
A planning question for each workstream
As an editorial planning suggestion, identify which technical-documentation, performance-evaluation and quality-system tasks support the next required milestone. Record who owns each task and what evidence closes it. Confirm the applicable pathway and submission expectations with appropriately qualified advisers and the selected notified body.
Sources & further reading
Read the original company post on LinkedInEuropean Commission — IVDR transition factsheetRegulation (EU) 2024/1860Adapted from a public company post, with sources checked on 8 October 2026. Original post dates are preserved; the website summary is not attributed to an individual employee.
