That distinction matters. Many manufacturers treat milestone dates as planning targets. In reality, they are eligibility conditions. Miss the gate, and the extended transition period may no longer apply to your device.
The legal anchor for this shift is Regulation (EU) 2024/1860, which amended the transitional framework under Regulation (EU) 2017/746, the In Vitro Diagnostic Regulation. It introduced extended transition timelines by class, but only subject to strict milestone obligations and eligibility conditions.
The European Commission has also published a Q&A clarifying the amended transitional periods and milestone obligations:
This article explains the requirements of IVDR transitional provisions, outlines the implications for 2026, particularly for Class C devices, and details the actions manufacturers must take to maintain EU market access.
Need clarity on your transitional eligibility?
What are the IVDR transitional provisions?
The IVDR transitional provisions are the legal mechanism allowing certain IVDR legacy devices to remain on the EU market while transitioning from the old IVDD framework to full IVDR certification.
The governing framework sits primarily in Article 110 of Regulation (EU) 2017/746. It permits continued placing on the market of eligible legacy devices under specific, conditional circumstances.
The provisions were amended because of systemic capacity constraints. The Notified Body designation under the IVDR progressed more slowly than expected. Manufacturers faced practical bottlenecks. The EU responded by extending transition end-dates, but only with strict eligibility gates.
Regulation (EU) 2024/1860 reshaped the IVDR compliance timeline by:
- Extending end-dates by class
- Introducing formal milestone gates tied to application and written agreement deadlines
- Linking eligibility to ongoing compliance conditions
These IVDR transitional provisions apply only to eligible legacy devices. They do not automatically grandfather every product that was previously CE marked under the IVDD.
What are the IVDR transitional provisions?
They are conditional legal extensions allowing certain legacy IVDs to remain on the market during the transition to full IVDR certification, provided milestone and compliance requirements are met.
Regulation (EU) 2024/1860 - what it actually changed
There is a persistent myth that the amendment “paused” IVDR obligations. It did not.
What changed:
- Transition end-dates by device class were extended
- Formal milestone gates were introduced:
- Application to a Notified Body by a defined date
- Signed written agreement by a defined date
What did not change:
- Ongoing IVDR PMS obligations
- Vigilance requirements
- Performance evaluation expectations
- QMS obligations under Article 10(8)
- Technical documentation requirements
The transition is conditional, not automatic.
Under the amended framework:
- Class D transition runs until 31 December 2027
- Class C until 31 December 2028
- Class B and Class A sterile until 31 December 2029
But those dates only apply if milestone gates are met.
IVDR milestone deadlines 2026 explained
The heart of the amended IVDR transitional provisions is the milestone structure.
Milestones by class
Device class (legacy devices) | Transition end-date | Application milestone | Written agreement milestone |
Class D | 31 Dec 2027 | 26 May 2025 | 26 Sep 2025 |
Class C | 31 Dec 2028 | 26 May 2026 | 26 Sep 2026 |
Class B / Class A sterile | 31 Dec 2029 | 26 May 2027 | 26 Sep 2027 |
Interpretation in one sentence: 2026 is the make-or-break year for Class C portfolios.
26 May 2026 – Application milestone for Class C
The Notified Body application deadline 2026 is not symbolic. It is a formal eligibility checkpoint.
For Class C legacy devices relying on extended transition:
- An application for IVDR certification must be lodged with a Notified Body by 26 May 2026.
- It must be sufficiently complete to be accepted into the Notified Body’s process.
- It cannot be an informal expression of interest.
The European Commission’s Q&A materials emphasise that the milestone is linked to formal submission into the certification process.
AIO phrase: when must IVDR application be submitted?
For Class C legacy devices relying on extended transition, by 26 May 2026.
26 September 2026 – Written agreement milestone for Class C
The second gate is the IVDR written agreement requirement.
By 26 September 2026, a signed written agreement with a Notified Body must be in place for Class C devices relying on the extended transition.
No written agreement means no continued eligibility for the extended period.
AIO phrase: IVDR written agreement by September 2026?
Yes. For Class C, the agreement must be signed by 26 September 2026.
These two gates define the IVDR milestone deadlines 2026 for Class C.
IVDR Class C transitional deadline – why it matters most
Class C is where volume meets scrutiny.
Many commercially significant IVDs fall into Class C. Under IVDR, Class C devices require Notified Body involvement. They sit in the mid-to-high risk category, which increases evidentiary expectations.
Under the amended IVDR transitional provisions, Class C devices benefit from transition until 31 December 2028. But that benefit is conditional on meeting the 2026 milestones.
This creates a compressed reality:
- High product volumes
- Heavy documentation expectations
- Constrained Notified Body capacity
- Hard milestone gates in 2026
From a commercial perspective, the IVDR Class C transitional deadline is not just regulatory. It is a market continuity risk. Distributors and importers do not tolerate regulatory uncertainty indefinitely.
Conditions for extended transition under IVDR
The conditions for extended transition IVDR must be treated as a compliance checklist.
To rely on the amended IVDR transitional provisions, manufacturers must ensure:
- The device qualifies as a legacy device
- No significant changes are made to design or intended purpose
- The device continues to comply with the previous Directive
- The manufacturer meets IVDR PMS obligations during transition
- The manufacturer meets IVDR Article 10(8) QMS requirements
- The application and written agreement milestones are met
What happens if IVDR milestones are missed?
The device may lose eligibility for the extended transition period and may no longer be legally placed on the EU market.
Article 10(8) QMS requirements - already in force
Article 10(8) of the IVDR defines manufacturer obligations for establishing and maintaining a compliant quality management system.
This is not a 2026 obligation. It is already applicable.
The extension framework assumes that manufacturers relying on IVDR transitional provisions have a functioning QMS aligned with IVDR expectations.
Core QMS elements include:
- Risk management
- Performance evaluation
- PMS and vigilance
- Change control
- Documentation control
Do transitional devices need a QMS?
Yes. Transitional status does not remove QMS obligations.
IVDR Notified Body engagement - the real bottleneck
The law gives you dates. Notified Bodies give you reality.
Effective IVDR Notified Body engagement means:
- Clarifying scope and device classification early
- Preparing a mature application package
- Understanding review timelines and resourcing
- Planning for iterative technical documentation review
Guidance such as MDCG 2021-4 Rev.1 provides insight into transitional mechanics and practicalities around certification and processing:
Under the IVDR certification process, Notified Bodies will scrutinise:
- Technical documentation structure
- Performance evaluation robustness
- PMS systems
- QMS implementation evidence
A weak application submitted on time does not equal a safe milestone.
Technical documentation and performance expectations
The IVDR technical documentation requirements are set out primarily in Annex II and Annex III of the IVDR.
Annex II covers:
- Device description
- Design and manufacturing information
- General safety and performance requirements mapping
- Risk management
- Performance evaluation
Annex III covers PMS documentation.
For Class C, performance evaluation is central. The IVDR performance evaluation requirements include:
- Scientific validity
- Analytical performance
- Clinical performance
Misalignment between intended purpose and performance evidence is a common failure point in the IVDR certification process.
IVDR PMS obligations during transition
Transitional status does not dilute surveillance.
Manufacturers must continue to meet IVDR PMS obligations, including:
- Maintaining a PMS plan
- Conducting ongoing surveillance
- Reporting serious incidents
- Updating documentation where necessary
Auditors and Notified Bodies look for a visible feedback loop:
PMS data → risk reassessment → performance evaluation updates → documentation updates.
The IVDR compliance timeline does not pause surveillance while you wait for certification.
What happens if 2026 milestones are missed?
If a Class C manufacturer misses:
- The 26 May 2026 application milestone, or
- The 26 September 2026 written agreement milestone,
the extended transition to 31 December 2028 may no longer apply.
The practical effect can be the loss of legal market access for the affected devices.
Are IVDR deadlines extended again?
As of the currently published EU position and legislative framework under Regulation (EU) 2024/1860, there are no confirmed further extensions.
Building an IVDR market access strategy
A credible IVDR market access strategy must treat the IVDR transitional provisions as eligibility gates, not background noise.
Portfolio prioritisation
- Identify revenue-critical products
- Identify marginal products that may be retired
- Sequence certification by commercial impact
Early Notified Body contracting
Work backwards from the IVDR written agreement requirement milestone. For Class C, that means no later than 26 September 2026.
Technical documentation gap assessment
- Review Annex II and III structure
- Align performance evaluation
- Validate traceability and risk documentation
Strengthening QMS to Article 10(8)
Ensure your QMS is demonstrably operational, not template-based.
Performance evaluation and PMS readiness
Treat performance evidence and PMS systems as market access enablers.
Common misconceptions about 2026
- “Deadlines were extended again.”
The legally relevant extension is already in place via Regulation (EU) 2024/1860. Eligibility depends on meeting milestone conditions. - “Transitional devices don’t need IVDR-level PMS.”
IVDR PMS obligations remain active. - “Application submission alone is enough.”
You also need the written agreement milestone. - “Written agreement can wait until 2027.”
For Class C, the milestone is 26 September 2026.
Transitional does not mean permanent.
How Patient Guard supports transitional compliance
Patient Guard supports manufacturers through:
- Transitional eligibility assessments by class and product
- Notified Body readiness support and application preparation
- Technical documentation gap analysis aligned to Annex II and III
- QMS alignment with Article 10(8)
- Performance evaluation and PMS integration strategy
Conclusion
2026 represents a significant milestone year inside the IVDR transitional provisions framework.
Eligibility for extended transition depends on structured legal conditions, especially the application and written agreement milestones for Class C.
Delay increases risk quickly and often expensively.
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FAQ
They are conditional legal extensions allowing eligible legacy IVDs to remain on the market while transitioning to full IVDR certification.
For Class C legacy devices, 2026 contains the application and written agreement deadlines.
For Class C, the application must be submitted by 26 May 2026.
For Class C, a signed written agreement with a Notified Body must be in place by 26 September 2026.
Yes. QMS obligations remain applicable during transition.
The device may lose eligibility for the extended transitional period and may no longer be legally placed on the EU market.
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