EU IVDR Transition Conditions under Article 110

1. Key takeaways

Continuing to benefit from the transition period under Article 110 requires two sets of conditions to be met simultaneously. The continuous conditions are: continued conformity with the original directive, no significant changes in design or intended purpose, and no unacceptable risk to health and safety. The time-point conditions are: establishing an IVDR quality management system conforming to Article 10(8) (before 26 May 2025), submitting the application for IVDR certification to a notified body (Class D 26 May 2025, Class C 26 May 2026, Class B and Class A sterile 26 May 2027), and signing a written agreement (Class D 26 September 2025, Class C 26 September 2026, Class B and Class A sterile 26 September 2027).

Missing any single time point ends the transitional period for the affected products, and failing a continuous condition ends it at the moment of failure. Because the QMS deadline applies uniformly to all classes, it is both the earliest and the most easily underestimated obligation in the entire legacy portfolio.

2. Legal basis

The table below lists the sources for the transition conditions and their time points.

Where the amending regulation and national authority tabulations differ in presentation, the binding text remains the consolidated Article 110 as amended by Regulation (EU) 2024/1860; the national pages serve as practical checklists.

3. Expert insights

Insight 1: the QMS time point is the single uniform deadline, and it has already passed.

According to the condition tables published by competent authorities, the time point for establishing a quality management system conforming to Article 10(8) of the IVDR is 26 May 2025, and it is not segmented by class. The Commission’s question-and-answer document adds that devices which were self-declared under the IVDD, and never certified by a notified body, must also have an IVDR-compliant QMS in place from 26 May 2025 if the transition is to be enjoyed; where none is established, the transitional period ends on that date. This is currently the largest stock of residual compliance risk, because the self-declared segment of the market has the least experience with notified body-grade quality systems.

Insight 2: the application submission and the written agreement are two independent time points, about four months apart.

The two time points are staggered by class: Class D at 26 May 2025 and 26 September 2025, Class C at 26 May 2026 and 26 September 2026, and Class B and Class A sterile at 26 May 2027 and 26 September 2027. Submitting the application without signing a written agreement within the window also fails the conditions. Since notified body capacity is scheduled contractually, the four-month gap is a hard constraint on negotiation timelines, not a formality, and it should be built into every quotation and audit planning discussion.

Insight 3: not applying is also permitted, but the consequences are explicit.

The Commission’s document makes clear that manufacturers are under no obligation to apply for IVDR certification for their legacy devices. Where a certificate expires after 9 July 2024 and before 26 May 2025, an extension can still be enjoyed if the conditions are met; but where the manufacturer does not submit an application for conformity assessment, the transitional period ends at the application time point. Each product line should therefore receive an explicit decision, apply or withdraw, documented at management level, rather than drifting into an accidental lapse through inaction.

Insight 4: the scope of the QMS must align with the thirteen aspects of Article 10(8).

Article 10(8) lists the aspects a QMS must at least cover: (a) regulatory compliance strategy and change management; (b) identification of and response plans for applicable GSPRs; (c) management responsibility; (d) resource management; (e) risk management; (f) performance evaluation including PMPF; (g) product realisation; (h) UDI assignment and verification; (i) the post-market surveillance system; (j) communication; (k) vigilance reporting; (l) corrective and preventive actions; and (m) monitoring and measurement of outputs and data analysis. Treating an ISO 13485 certificate as sufficient evidence of the QMS usually falls short, because the mapping from the standard onto these thirteen aspects must be demonstrated, not presumed.

4. Practical recommendations

1. Start with a QMS gap analysis: use the thirteen items of Article 10(8) as the checklist and close each item with procedures and records.
2. Draw a dual-node Gantt chart of application submission and written agreement per class, and treat notified body scheduling as a predecessor dependency.
3. Run an entry-by-entry impact analysis for partial-application scenarios, so that uncovered entries do not lapse early.
4. Assemble an evidence package: records of QMS establishment, submission receipts, the original written agreement and copies of certificates.
5. For product lines that are being withdrawn, start early on the Article 10a supply-interruption notification assessment and customer communication (see part 45 of this series).

5. Verification checklist

• □ A QMS conforming to Article 10(8) established, with evidence of effectiveness before 26 May 2025 retained
• □ IVDR certification applications submitted by class before 2025, 2026 or 2027-05-26
• □ Written agreements signed by class before 2025, 2026 or 2027-09-26
• □ Entry-by-entry impact analysis completed for the partial-application scenario
• □ The continuous conditions, conformity, no significant changes, no unacceptable risk, integrated into internal audits
• □ The evidence package archived and available to competent authorities on request

Regulatory information verified as of 29 October 2026.

GRZAN manages transition-condition compliance under Article 110, from QMS gap analyses against Article 10(8) to the sequencing of applications and written agreements with notified bodies, keeping legacy IVD portfolios eligible through to IVDR certification. For tailored compliance support on the EU IVDR market, contact info@grzanglobal.com.