IVDR Class C Transition Deadline: What IVD Manufacturers Must Do Before May 26, 2026

Why the IVDR Class C Deadline Matters Now

On May 26, 2026, a critical regulatory milestone arrives for in vitro diagnostic (IVD) manufacturers: legacy Class C devices previously self-certified under the In Vitro Diagnostic Directive (IVDD 98/79/EC) must have a formal Notified Body application lodged. Missing this deadline means losing access to the extended transition pathway that allows continued EU market presence through December 31, 2028. Without it, your device must be pulled from the market until full IVDR certification is granted — a process that currently takes 18 to 24 months on average.

This is not a theoretical concern. As of early 2026, only approximately 10 to 12 Notified Bodies are designated under the IVDR, and their capacity is already strained. The Class D IVDR deadline (May 2025) has passed, and many manufacturers who missed it were forced to withdraw products from the EU market. The Class C deadline is the next critical checkpoint, and it is days away.

This guide explains exactly what the deadline requires, who it affects, what happens if you miss it, and the practical steps to take right now.

Who Is Affected: Understanding IVDR Class C Devices

What Are Class C Devices Under IVDR?

Under IVDR Annex VIII Classification Rules, Class C devices are those that present a high individual risk or moderate public health risk. They include:

• Infectious disease assays that guide isolation or treatment decisions (e.g., HIV, hepatitis, sexually transmitted infections)
• Oncology markers that shape therapeutic pathways (e.g., HER2, BRCA, PSA screening)
• Genetic tests underpinning personalized medicine
• Companion diagnostics that determine eligibility for specific therapies
• Self-testing devices for detecting infectious agents
• Blood grouping assays for transfusion purposes

Under the old IVDD, the vast majority of these devices were self-certified. Manufacturers compiled technical documentation and issued their own Declaration of Conformity without Notified Body involvement. The IVDR fundamentally changed this: Class C devices now require conformity assessment by a Notified Body.

The Reclassification Shock

One of the most challenging aspects of the IVDR transition is that many devices that were low-risk under the IVDD are now Class C under the IVDR. The IVDR introduced a new risk-based classification system with Rules 1 through 7 in Annex VIII, replacing the IVDD's two-tier system (List A, List B, everything else). Key examples of devices that moved from IVDD self-certification to IVDR Class C include:

• Many infectious disease rapid tests
• Certain cancer screening assays
• Genetic predisposition tests
• Some point-of-care testing devices
• Self-testing devices for various analytes

If your device was self-certified under the IVDD and is now Class C under the IVDR, you must submit a Notified Body application by May 26, 2026 to benefit from the extended transition period.

The IVDR Class C Transition Timeline

Complete Milestone Schedule

How Extended Transition Works (Regulation (EU) 2024/1860)

The extended transition provisions under Article 110(3c) of the IVDR (as amended by Regulation (EU) 2024/1860) allow legacy Class C devices to remain on the EU market until December 31, 2028 — but only if manufacturers meet specific milestones along the way. These milestones are not optional benchmarks; they are hard conditions that determine whether the transition period applies to your device.

The May 26, 2026 deadline is the second milestone in this sequence. You must have submitted a formal application to a Notified Body by this date. The September 26, 2026 deadline is the third milestone: you must have a signed written agreement with that Notified Body.

Conditions for Eligibility

To benefit from the extended transition period, all of the following conditions must be continuously met:

1. The device continues to comply with the IVDD — no relaxation of safety or performance standards
2. No unacceptable risk to health or safety has been identified
3. No significant changes to the device design or intended purpose
4. IVDR-compliant QMS was in place by May 26, 2025
5. Formal NB application lodged by May 26, 2026
6. Written agreement with NB signed by September 26, 2026
7. EUDAMED registration of legacy devices by November 27, 2026

Missing any single condition disqualifies the device from the transition pathway.

What Happens If You Miss the May 26 Deadline

If you do not submit a formal application to a Notified Body by May 26, 2026:

• Your device loses eligibility for the extended transition period immediately
• You cannot legally place the device on the EU market
• Products already in the supply chain may continue to be sold (the "sell-off" provision was removed by Regulation (EU) 2024/1860, meaning devices already placed on the market before the transition deadline can continue to be made available)
• You must obtain full IVDR certification before re-entering the market
• Full conformity assessment currently takes 18 to 24 months on average, during which the device cannot be sold in the EU
• Notified Body queues are long, and capacity is limited — late applicants face even longer waits

The Notified Body Challenge

Current IVDR Notified Body Capacity

As of early 2026, only approximately 10 to 12 Notified Bodies hold IVDR designation across the EU. This is far fewer than the number that operated under the IVDD, and the IVDR conformity assessment process is significantly more demanding. The result is a capacity bottleneck that makes timely engagement critical.

Key IVDR-designated Notified Bodies include BSI, TÜV SÜD, DNV, GMED (LNE Group), SGS, and a handful of others. Each has different lead times, areas of specialization, and pricing structures.

Practical Advice for NB Engagement

If you have not yet engaged a Notified Body:

1. Contact multiple NBs immediately. Do not rely on a single application. Submit to more than one to increase your chances of securing an agreement by September 2026.
2. Prepare a complete application package. Incomplete submissions delay the process. Include your IVDR classification rationale, gap analysis summary, QMS documentation status, and a preliminary technical file outline.
3. Request a structured dialogue. The new Implementing Regulation (EU) 2026/977 formally introduces structured dialogue between manufacturers and Notified Bodies, allowing pre-submission discussions to clarify requirements.
4. Prioritize your portfolio. If you have many Class C devices, work with the NB to agree on a phased submission plan that covers your most commercially critical products first.

The Evidence Burden for Class C Devices

What Notified Bodies Will Scrutinize

IVDR conformity assessment for Class C devices involves a full review of:

• Technical documentation — performance evaluation, analytical and clinical performance data, scientific validity reports
• Performance evaluation report — a comprehensive document that demonstrates the device meets its intended performance claims
• Scientific validity — evidence that the analyte being measured is clinically relevant to the condition being diagnosed or monitored
• Analytical performance — precision, accuracy (trueness), limits of detection and quantification, measuring range, specificity, interference
• Clinical performance — data from clinical studies, published literature, or equivalent device comparisons demonstrating clinical utility
• Post-market performance follow-up (PMPF) plan — ongoing monitoring to confirm continued safety and performance
• Labeling and IFU — instructions for use that comply with IVDR Article 10(11) and Annex I requirements
• QMS documentation — evidence that the quality management system meets IVDR Article 10 requirements and ISO 13485

Three Primary Drivers of Class C Complexity

1. Infectious disease assays must demonstrate sensitivity and specificity for the target population, including co-infections and cross-reactivity with related pathogens. Clinical performance data across diverse demographics is increasingly expected.

2. Oncology markers must show clinical validity — that the biomarker result meaningfully guides treatment decisions. Companion diagnostics face the additional burden of linking the diagnostic result to therapeutic outcome data.

3. Genetic tests must address the complexity of variant interpretation, population-specific allele frequencies, and the evolving nature of genomic knowledge. Post-market surveillance must include mechanisms to update variant classifications.

Common Pitfalls to Avoid

1. Misclassified Devices

Double-check and confirm your IVDR classification rationale. The transition from IVDD to IVDR reclassified many devices. Some manufacturers discover too late that a device they classified as Class B is actually Class C (or vice versa). Use IVDR Annex VIII rules systematically and document your reasoning.

2. Incorrect Transition Timeline Assumptions

Not all devices qualify as "legacy devices" under Article 110. A device must have had a valid IVDD certificate or declaration of conformity before May 26, 2022 (the IVDR date of application). New devices — those launched after that date without prior IVDD certification — are not eligible for transition provisions and must comply with the IVDR immediately.

3. Late Engagement With Notified Bodies

Delaying engagement significantly increases the risk of missed deadlines. Even if you submit a formal application by May 26, 2026, you must still negotiate and sign a written agreement by September 26, 2026. Starting the conversation in May leaves very little time for this second step.

4. Incomplete Application Packages

Incomplete submissions are the most common cause of delays in the conformity assessment process. Ensure your application includes:

• Completed application form with device identification and classification
• IVDR classification rationale document
• List of devices covered by the application
• Current IVDD declaration of conformity (for legacy devices)
• QMS certificate (ISO 13485) or evidence of IVDR-compliant QMS
• Preliminary technical documentation outline

5. Underestimating Clinical Performance Study Timelines

If your technical documentation gap analysis reveals that a prospective clinical performance study is needed to support IVDR claims, you may already be behind. Ethics approval, protocol design, patient recruitment, and data collection typically require 12 to 24 months. Manufacturers should evaluate existing data against IVDR claims immediately, and consider whether the intended use or claims can be adjusted to leverage existing data, or whether post-market performance follow-up (PMPF) activities can bridge the gap.

6. Neglecting EUDAMED Registration

Legacy devices must be registered in EUDAMED by November 27, 2026. This is a separate requirement from the Notified Body application, and it involves substantial data entry (UDI/Device Registration module). Manufacturers with large portfolios should begin EUDAMED registration planning immediately.

Step-by-Step Action Plan

If You Have Not Yet Started

If You Have Started but Are Not Yet Complete

• Confirm your application has been formally received and acknowledged by the Notified Body. A submission is not the same as a received application.
• Begin negotiating the written agreement in parallel with the application review. Do not wait for the application to be fully processed before starting contract discussions.
• Accelerate your technical documentation remediation. The conformity assessment process will require a complete IVDR-compliant technical file. Start this work now to avoid delays during the formal review.

The Bigger Picture: IVDR Transition by Class

Frequently Asked Questions

Can I continue to sell my Class C device after May 26, 2026 if I have submitted my application? Yes, provided you meet all other conditions (IVDD compliance, IVDR-compliant QMS, no significant changes). The May 26 deadline is about submitting the application, not completing certification.

What if my Notified Body application is rejected? You must submit a new application to another Notified Body. The transition provisions require a valid application, not just an attempt. Have backup applications with other NBs.

Do I need EUDAMED registration before May 26, 2026? No. EUDAMED mandatory registration for legacy devices is November 27, 2026. However, EUDAMED registration becomes mandatory for new MDR/IVDR devices on May 28, 2026.

Can I make changes to my device during the transition period? No significant changes to the device design or intended purpose are permitted during the transition period. Minor changes may be possible under your change control process, but anything that affects safety, performance, or intended use would disqualify the device from transition provisions.

What is the difference between the IVDR application deadline and the transition deadline? The application deadline (May 26, 2026) is when you must have formally applied to a Notified Body. The transition deadline (December 31, 2028) is when full IVDR certification must be in place. The transition period only applies if you hit all the intermediate milestones.

Should I delay my submission because the MDR/IVDR revision is being discussed? No. The European Commission's proposed MDR/IVDR revision is a legislative process that will take time. The current deadlines remain legally binding regardless of future legislative changes. Missing the May 2026 deadline based on speculation about future reforms is a significant compliance risk.

Key Takeaways

1. May 26, 2026 is a hard deadline for IVDR Class C legacy device manufacturers to submit formal Notified Body applications. There is no grace period.
2. September 26, 2026 is the equally hard deadline for signing a written agreement with a Notified Body.
3. Notified Body capacity is limited. Only approximately 10 to 12 NBs are IVDR-designated. Engage multiple NBs immediately.
4. The full certification deadline is December 31, 2028, but the pathway to that deadline requires hitting every intermediate milestone.
5. EUDAMED registration by November 27, 2026 is a separate but equally mandatory requirement.
6. Missing any milestone means losing market access until full IVDR certification is obtained — a process taking 18 to 24 months.
7. The European Commission publishes a dashboard on "Monitoring of availability of medical devices on the EU market" with average certification timelines — use it to plan your submissions.
8. The EC Q&A document on extended IVDR transitional periods provides authoritative clarification on eligibility conditions and should be consulted alongside this guide.