Manufacturers of certain legacy Class C IVDs must have a written agreement with a Notified Body in place by 26 September 2026 to remain eligible for the extended IVDR transition period.

The transition to the EU In Vitro Diagnostic Medical Devices Regulation (IVDR) continues to present significant regulatory challenges for manufacturers across Europe. While Regulation (EU) 2024/1860 introduced extended transition timelines to help prevent potential shortages of in vitro diagnostic medical devices, these extensions are subject to specific conditions and deadlines.

One of the most important upcoming milestones is 26 September 2026.

Manufacturers of Class C self-declared legacy IVDs that intend to continue placing their devices on the EU market under the extended transition provisions must take action before this deadline.

What changed under Regulation (EU) 2024/1860?

Regulation (EU) 2024/1860, published in the Official Journal of the European Union on 9 July 2024, amended both the Medical Device Regulation (MDR) and the In Vitro Diagnostic Medical Devices Regulation (IVDR).

The Regulation was introduced, in part, to address concerns that the transition from the previous In Vitro Diagnostic Medical Devices Directive (IVDD) to the IVDR was progressing more slowly than anticipated. Without additional flexibility, this could have resulted in the withdrawal of certain devices from the EU market and potential supply disruptions.

To address these concerns, the Regulation extended the IVDR transition timelines for certain legacy devices.

However, manufacturers should not interpret these extended timelines as an automatic extension. Eligibility depends on meeting specific conditions established under the amended Article 110 of the IVDR.

The 26 September 2026 deadline: What manufacturers need to know

For manufacturers of Class C self-declared IVDs, one critical requirement is approaching.

No later than 26 September 2026, manufacturers must have signed a formal written agreement with a Notified Body.

Meeting this requirement is necessary for manufacturers seeking to benefit from the applicable extended transition provisions and continue placing eligible legacy devices on the EU market.

For eligible devices, the transition period may extend until 31 December 2028, provided that all applicable conditions under Regulation (EU) 2024/1860 are fulfilled.

This means that manufacturers should carefully review their regulatory strategy well before the deadline.

Why this deadline matters

The IVDR significantly expanded the role of Notified Bodies in the conformity assessment of IVDs.

Under the previous IVDD framework, many devices could be self-declared by manufacturers. Under the IVDR, however, a substantially larger number of devices require the involvement of a Notified Body.

The extended transition provisions were designed to provide manufacturers with additional time to complete the transition. However, manufacturers must demonstrate that they are actively progressing toward IVDR compliance.

For Class C self-declared legacy IVDs, establishing a formal relationship with a Notified Body is therefore a critical regulatory milestone.

Failing to meet the applicable conditions by the required deadlines could affect a manufacturer's ability to continue placing a legacy device on the EU market under the transition provisions.

Extended transition periods are conditional

The extended IVDR timelines may provide manufacturers with valuable additional time, but they should not be viewed as a reason to delay transition activities.

Manufacturers must ensure that their devices meet all applicable conditions under the amended IVDR framework.

Depending on the device and its regulatory status, these conditions may include:

• Maintaining compliance with applicable requirements under the previous IVDD framework.
• Ensuring that there are no significant changes in the design or intended purpose of the device.
• Meeting the applicable post-market surveillance requirements.
• Establishing the required relationship with a Notified Body within the relevant deadline.
• Progressing toward conformity with the IVDR.

Manufacturers should therefore evaluate their individual product portfolios and transition plans to determine which deadlines and requirements apply to each device.

What about transferring an IVDR application?

Manufacturers that have already initiated their IVDR transition may also need to consider their Notified Body strategy.

According to the information provided by BSI, manufacturers may be able to transfer their IVDR application for legacy devices while maintaining their transition regulatory status, including the transfer of applicable surveillance activities.

This highlights the importance of proactively managing Notified Body relationships and regulatory timelines.

Manufacturers considering a transfer should carefully evaluate the requirements, timelines and regulatory implications associated with their specific situation.

Key actions manufacturers should consider now

With the 26 September 2026 deadline approaching, manufacturers of affected Class C self-declared IVDs should consider taking the following steps:

1. Review your product portfolio

Identify all legacy IVDs currently placed on the EU market and determine which devices are eligible for the extended IVDR transition provisions.

2. Confirm your device classification

Ensure that your device classification under the IVDR has been correctly determined and identify whether the device falls within the Class C self-declared category affected by the September 2026 deadline.

3. Review your transition strategy

Assess the current status of your IVDR transition activities, including technical documentation, clinical evidence, performance evaluation and post-market surveillance requirements.

4. Engage with a Notified Body

If applicable, manufacturers should ensure that the required written agreement with a Notified Body is established before the relevant deadline.

Waiting until the final weeks before the deadline may create unnecessary regulatory and operational risks.

5. Monitor regulatory developments

The IVDR transition remains a complex and evolving process. Manufacturers should continue monitoring guidance, regulatory updates and Notified Body requirements that may affect their transition strategy.

The bottom line

26 September 2026 is a critical regulatory deadline for manufacturers of Class C self-declared legacy IVDs.

Manufacturers that intend to continue benefiting from the applicable IVDR transition provisions should ensure that they understand the requirements established under Regulation (EU) 2024/1860 and take the necessary actions within the required timeframe.

The extended transition timelines provide additional flexibility, but they are conditional.

For many manufacturers, the priority now should be clear: review the product portfolio, confirm regulatory eligibility, assess the IVDR transition plan and ensure that the required Notified Body arrangements are in place before the deadline.

Early action can help reduce the risk of regulatory disruption and support continued market access while the transition to the IVDR progresses.

Need support with your IVDR transition?

Navigating the IVDR transition requires careful planning, particularly for manufacturers managing legacy devices, evolving classification requirements and Notified Body involvement.

A proactive regulatory strategy can help manufacturers identify applicable deadlines, evaluate transition eligibility and prepare for continued compliance under the EU regulatory framework.

As the September 2026 deadline approaches, now is the time to review your IVDR transition strategy.