IVDR Transition Timeline: What Has Passed and What Still Matters in 2026

The regulatory landscape for diagnostic devices in the European Union has undergone a major transformation with the shift from the In Vitro Diagnostic Medical Devices Directive (IVDD) to the In Vitro Diagnostic Medical Devices Regulation (IVDR).

While IVDR officially came into force on 26 May 2022, the transition process remains ongoing, reflecting the broader goal of replacing the IVDD with a more robust, transparent, and risk-based regulatory framework for in vitro diagnostic devices. The original plan was to complete the transition within a set timeline, but in reality, several practical challenges made this difficult. As a result, regulators introduced phased deadlines, allowing different transition periods depending on the risk classification of the devices, to ensure a more manageable and effective transition.

Now, as we move through 2026, it’s important for manufacturers, regulatory professionals, and other stakeholders to stay updated on which deadlines have already passed, which ones are approaching, and what steps are still needed to achieve full compliance.

IVDR Transition Timelines

Note :

IVDD certified devices: Devices that received certification from a Notified Body under the IVDD framework

IVDD self-declared devices: Devices placed on the market under IVDD without requiring certification from a Notified Body.

These extensions, backed by the European Commission, were put in place to avoid disruptions in the market and to make sure that essential diagnostic devices remain available to patients and healthcare providers.

What Deadlines Have Already Passed

For IVDD-certified devices and Class D devices:

For many manufacturers of IVDD-certified devices and Class D, a large part of the IVDR transition timeline has already passed. Important milestones such as implementing an IVDR-compliant QMS and submitting formal applications by 25 May 2025 are now behind us, leaving little room for delays.

However, manufacturers who have taken action within the designated timeframes still have access to compliance routes. Manufacturers who managed to secure a formal written agreement with a Notified Body by September 2025 can continue to make use of the extended transition period. This allows them to remain on the market while completing their IVDR compliance activities in a more planned and manageable way, rather than facing last-minute pressure or potential supply interruptions.

Upcoming IVDR Compliance Milestones

Class C Devices – Deadline: May 2026

A key upcoming milestone is 26 May 2026, which is particularly relevant for Class C devices continuing under the extended IVDR transition provisions. By this stage, manufacturers are expected to be actively engaged in the conformity assessment process, with their application already submitted and under review by a Notified Body.

This milestone serves as an important indicator of progress. Manufacturers should have their technical documentation well-developed, performance evaluation in place, and any identified gaps already being addressed. Delays at this point may put overall timelines at risk, especially given the limited capacity of Notified Bodies and the complexity of Class C assessments.

Staying on track beyond this date is essential to ensure timely certification and to avoid potential disruptions to market access as final transition deadlines approach.

Class B and Class A (Sterile) Devices – Deadline: May 2027

Class B and Class A (sterile) devices are generally considered lower risk, but they make up a large portion of the products currently available in the EU market. Under Regulation (EU) 2017/746, many of these devices that were previously self-declared under IVDD now require involvement from notified bodies. This is a major shift for manufacturers who may not be familiar with such rigorous regulatory oversight.

Although the May 2027 deadline may seem far away, it can quickly become challenging due to the sheer number of devices that need to transition and the ongoing limitations in notified body capacity. If companies delay their preparations, they may face difficulties securing timely assessments later on.

To avoid last-minute pressure, manufacturers should start preparing early by updating their technical documentation and strengthening their quality management systems. Taking a proactive approach now can help ensure a smoother transition and reduce the risk of delays or disruptions in market access in the future.

Conclusion

The remaining IVDR deadlines are essentially the last real opportunity for manufacturers to bring their devices into compliance. While the extensions have certainly offered some breathing space, they have also led some manufacturers to believe they still have plenty of time, which isn’t really the case anymore.

In practice, the expectations under the Regulation (EU) 2017/746 remain just as strict. Manufacturers that take action now by planning ahead, staying organised, and strengthening their compliance systems will be in a much better position not only to meet the deadlines but also to stay competitive in the changing European diagnostics market.