Updated: 23rd June 2026
Reviewed by: David Small, BSc (Hons), MSc, MTOPRA (Founder and CEO)
IVDR Transitional Framework
The amended IVDR transitional framework does not provide manufacturers with unconditional extensions to the original certification deadlines. Instead, the revised timelines are subject to strict legal conditions that manufacturers must satisfy to remain eligible. The key milestone dates are not planning targets—they are mandatory eligibility requirements. Missing either the application or written agreement deadline may result in the loss of the extended transition period for the affected device.
These changes were introduced through Regulation (EU) 2024/1860, which amended the transitional provisions of Regulation (EU) 2017/746 (IVDR) in response to limited Notified Body capacity and the risk of widespread market disruption. The amended legislation extends the transition period for eligible legacy devices, but only where manufacturers continue to meet defined compliance obligations and achieve the required milestones within the specified deadlines.
This guide explains how the amended IVDR transitional provisions work, the key milestones manufacturers must meet in 2026, particularly for Class C devices, and the practical steps needed to maintain eligibility for continued EU market access.
Need the Full IVDR Picture?
Transitional provisions are only one part of the EU In Vitro Diagnostic Regulation. For a complete overview of IVDR classification, performance evaluation, technical documentation, CE marking, UDI, EUDAMED and compliance requirements, read our Complete EU IVDR Guide.
Understand Regulation (EU) 2017/746
Want to understand the legislation behind the IVDR transition? Explore our detailed guide to Regulation (EU) 2017/746, covering the scope of the IVDR, risk classification, conformity assessment, performance evaluation, CE marking and the regulatory requirements for placing IVDs on the European market.
What are the IVDR transitional provisions?
The IVDR transitional provisions are a legal mechanism that allows certain legacy in vitro diagnostic medical devices (IVDs) to remain on the European Union market while manufacturers transition from compliance with the In Vitro Diagnostic Directive (IVDD) to full certification under the In Vitro Diagnostic Medical Devices Regulation (IVDR).
The legal basis for these provisions is found primarily in Article 110 of Regulation (EU) 2017/746, which permits eligible legacy devices to continue being placed on the market under defined conditions while manufacturers progress through the IVDR conformity assessment process.
Following the introduction of the IVDR, the designation of Notified Bodies progressed more slowly than anticipated, creating significant capacity constraints across the European regulatory system. As a result, many manufacturers faced delays in securing conformity assessments despite actively working towards compliance. To reduce the risk of essential IVDs being withdrawn from the market, the European Union adopted Regulation (EU) 2024/1860, which amended the transitional framework.
The amended legislation extended the transition periods for eligible legacy devices while introducing stricter eligibility requirements. These include:
Extended transition end-dates based on device classification.
Mandatory application and written agreement milestones with a Notified Body.
Ongoing compliance obligations, including maintenance of an IVDR-compliant quality management system and continued fulfilment of applicable regulatory requirements.
It is important to understand that these transitional provisions are conditional, not automatic. They apply only to eligible legacy devices that continue to satisfy all of the legal requirements throughout the transition period. Devices that fail to meet the prescribed milestones or ongoing compliance obligations may lose the benefit of the extended transition and no longer be eligible to remain on the EU market.
What are the IVDR transitional provisions?
The IVDR transitional provisions are conditional legal measures that allow eligible legacy IVDs to continue being placed on the EU market while manufacturers complete the transition to full IVDR certification, provided all applicable milestone deadlines and ongoing compliance requirements are met.
Do You Need an EU Authorised Representative?
If your company is based outside the European Union, appointing an EU Authorised Representative (EC REP) is a legal requirement before placing IVDs on the EU market. Learn about Article 11 obligations, manufacturer responsibilities, EUDAMED requirements and how to choose the right representative in our Complete Guide to EU Authorised Representatives.
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 |
Need Help Determining Your IVDR Classification?
The IVDR transitional timelines are based on the risk classification of your IVD. If you're unsure how to determine whether your device is Class A, B, C or D, how the seven IVDR classification rules are applied or what your classification means for conformity assessment and transition deadlines, explore our Complete Guide to IVDR Classification.
2026 - Class C IVDs
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.
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.
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.
Submitted Your IVDR Class C Application?
Meeting the application and written agreement milestones is only the beginning. Learn what happens after submission, including Notified Body review timelines, common causes of delays, technical documentation assessments and how to maintain your path to IVDR certification in our Post-Deadline Reality Check Guide.
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.
Understand Your Article 10 IVDR Obligations
Meeting the IVDR transitional deadlines also means complying with the ongoing legal responsibilities placed on manufacturers. Learn about Article 10 requirements covering quality management systems, technical documentation, post-market surveillance, risk management, PRRC responsibilities and lifecycle compliance in our Guide to Article 10 of the EU IVDR.
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.
Need Practical Help Achieving IVDR Compliance?
Preparing for the IVDR transition involves far more than meeting regulatory deadlines. Discover practical strategies for technical documentation, performance evaluation, quality management systems, Notified Body readiness and achieving successful IVDR certification in our Practical IVDR Compliance Guide.
Is Your IVDR Performance Evaluation Ready?
Meeting the transitional deadlines is only part of the challenge. Your Performance Evaluation must also demonstrate robust scientific validity, analytical performance and clinical performance. See how these requirements fit together in our Complete Guide to IVDR Performance Evaluation.
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 the 2026 deadlines
- “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.
Do You Understand Your Legal Responsibilities Under the IVDR?
IVDR compliance isn't just the manufacturer's responsibility. Importers, distributors, authorised representatives and other economic operators all have defined legal obligations under the regulation. Learn who is responsible for what, the risks of non-compliance and how to protect your business in our Guide to MDR & IVDR Economic Operator Obligations.
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.
Manufacturers that engage early with their Notified Body, maintain an IVDR-compliant quality management system and prepare robust technical documentation will be significantly better placed to achieve certification and maintain uninterrupted access to the European market.
Frequently Asked Questions About IVDR transitional provisions
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.
References
The information presented in this guide has been prepared with reference to the following legislation, standards and official regulatory guidance relating to the IVDR transitional provisions and ongoing compliance requirements.
| Organisation | Reference | Relevance |
|---|---|---|
| European Union | Regulation (EU) 2017/746 on In Vitro Diagnostic Medical Devices (IVDR) | Primary legislation governing in vitro diagnostic medical devices within the European Union. |
| European Union | Regulation (EU) 2024/1860 | Amends the IVDR transitional provisions, extending transition periods and introducing milestone requirements for manufacturers. |
| European Commission | Medical Devices and IVD Guidance Documents | Official guidance supporting implementation of the MDR and IVDR. |
| European Commission | MDCG Guidance Documents | Official guidance published by the Medical Device Coordination Group to support interpretation and application of the IVDR. |
| European Commission | Notified Bodies for Medical Devices | Information on the designation, oversight and role of Notified Bodies in conformity assessment. |
| International Organization for Standardization (ISO) | ISO 13485:2016 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes | International standard for quality management systems supporting regulatory compliance for medical device and IVD manufacturers. |
| International Organization for Standardization (ISO) | ISO 14971:2019 – Medical Devices – Application of Risk Management to Medical Devices | International standard describing the application of risk management throughout the medical device lifecycle. |
IVDR legislation, transitional provisions, regulatory guidance and recognised standards continue to evolve. Manufacturers should always consult the latest published legislation, standards and official guidance when planning certification activities and maintaining eligibility under the IVDR transitional framework.
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