The transition from the In Vitro Diagnostic Directive to the In Vitro Diagnostic Regulation represents one of the most significant regulatory shifts for diagnostic manufacturers in Europe. While the IVDR introduced stricter requirements for clinical evidence, quality systems and notified body oversight, the original transition timelines proved unworkable for much of the industry. As a result, extended timelines have been introduced to allow continued market access for legacy devices while manufacturers progress toward full IVDR compliance. Understanding these timelines and the conditions attached to them is essential for manufacturers planning certification, maintaining supply and managing regulatory risk.
Why the IVDR Transition Was Extended
The IVDR transition was extended in response to capacity constraints and implementation challenges. The number of notified bodies designated under IVDR has been limited, while the volume of devices requiring certification has increased significantly compared to the previous directive. Many legacy devices that were self declared under IVDD now require notified body involvement under IVDR, creating a bottleneck in conformity assessment.
Without extended timelines, there was a significant risk of devices being withdrawn from the market, potentially impacting patient care and public health. The revised timelines aim to balance regulatory rigour with practical feasibility, ensuring that safe and effective devices remain available while manufacturers transition to the new framework.
IVDR Transition Deadlines by Device Class
The extended IVDR transition timelines are structured according to device risk class. Before reviewing specific dates, it is important to recognise that these timelines apply only to devices that meet defined transition conditions.
For legacy IVDD certified devices, applications to notified bodies and written agreements must have been in place by 26 May 2025, with transition permitted until 31 May 2027, subject to certificate validity.
Class D devices, which represent the highest risk IVDs, must have submitted applications by 26 May 2025 and signed agreements with notified bodies by 26 September 2025. These devices may remain on the market until 31 December 2027.
Class C devices must submit applications by 26 May 2026 and secure agreements by 26 September 2026, with a final transition deadline of 31 December 2028.
Class B and Class A sterile devices must submit applications by 26 May 2027 and sign agreements by 26 September 2027, with transition extended until 31 December 2029.
It is important to note that Class A non sterile devices should already comply fully with IVDR requirements and are not eligible for extended transition.
Conditions for Transition Eligibility
The extended timelines are not automatic. Manufacturers must meet specific conditions to benefit from them.
Devices must continue to comply with IVDD requirements throughout the transition period. Significant changes to design or intended purpose are not permitted. This restriction is critical and often misunderstood, as even seemingly minor modifications may invalidate transition eligibility.
Devices must not present an unacceptable risk to patient safety or public health. Manufacturers must maintain active oversight of safety performance and address any issues promptly.
A fully implemented quality management system compliant with IVDR Article 10(8) must have been in place by 26 May 2025. This requirement applies regardless of the device class and is a key milestone for all manufacturers.
Notified Body Engagement and Transfer Considerations
Notified body engagement is central to the transition process. Manufacturers must secure a written agreement with a notified body within the defined timelines. Failure to do so removes eligibility for extended transition and may result in loss of market access.
In cases where a manufacturer applies to a different notified body than the one that issued the IVDD certificate, additional considerations apply. Under Regulation (EU) 2024/1860, the new notified body may take over surveillance activities, subject to agreement between both notified bodies and the manufacturer. However, the new notified body is not responsible for conformity assessment activities carried out under the IVDD certificate.
This distinction introduces complexity in managing dual relationships and requires careful coordination to ensure continuity of surveillance and compliance.
Strategic Risks of Delaying IVDR Applications
Although extended timelines provide flexibility, delaying IVDR applications carries significant risk. Manufacturers who postpone submission may find themselves at the end of notified body review queues, leading to delays in certification and potential interruptions in market access.
Only devices that have entered the transition process benefit from extended timelines. If an application has not been submitted, the device may not qualify for continued market access under IVDD.
Manufacturers must also recognise that notified body capacity remains limited. Late submissions increase the likelihood that applications cannot be reviewed within required timeframes. Early engagement and proactive planning are therefore essential to mitigate risk.
Classification Changes Under IVDR
One of the most important considerations for manufacturers is that device classification under IVDR may differ from classification under IVDD. Many devices have been up classified, particularly those involving higher risk diagnostic functions or new technologies.
Manufacturers should conduct a full reclassification exercise to confirm the correct risk class under IVDR. Incorrect assumptions about classification can lead to inappropriate submission strategies, delays in certification and increased regulatory risk.
Supply Chain and Discontinuation Obligations
The updated regulatory framework also introduces new obligations related to supply chain continuity. Under Article 10a of Regulation (EU) 2024/1860, manufacturers must provide advance notice if they anticipate an interruption or discontinuation of supply that could result in serious harm to patients or public health.
At least six months’ notice must be given to the competent authority of the relevant member state, as well as to economic operators, health institutions and healthcare professionals. The competent authority then communicates this information to other member states and the European Commission where the device is marketed.
These requirements place additional responsibility on manufacturers to monitor supply chain risks and communicate proactively with stakeholders.
EUDAMED Implementation Timeline
EUDAMED, the European database for medical devices, is being implemented through a phased approach. Rather than a single launch, individual modules are introduced gradually and become mandatory after being declared fully functional.
As of early 2026, four modules have been declared functional, including Actor registration, UDI and device registration, notified bodies and certificates, and market surveillance. The mandatory use of these modules begins on 28 May 2026.
Legacy devices must be registered in EUDAMED by 27 November 2026. This requirement applies even if devices are still operating under IVDD transition provisions. Manufacturers must ensure that data submission processes are in place and aligned with regulatory expectations.
Practical Next Steps for Manufacturers
Manufacturers should take a structured approach to managing the IVDR transition. Immediate priorities include confirming device classification under IVDR, implementing a compliant quality management system, engaging with a notified body and submitting applications within required timelines.
Organisations should also review design and change control processes to ensure that no prohibited changes are made during the transition period. Supply chain monitoring and communication processes must be established to meet new regulatory obligations.
Preparation for EUDAMED registration should begin early, including validation of device data and alignment of internal systems. Manufacturers that take proactive steps now will reduce the risk of delays and maintain continuity of market access.
LFH supports IVD manufacturers in navigating the IVDR transition with clarity and confidence, from classification and notified body engagement to EUDAMED readiness and certification strategy. Our team helps organisations reduce regulatory risk, maintain market access and progress efficiently toward full IVDR compliance.
FAQs – IVDR Transition
Can all IVDs benefit from the extended IVDR timelines?
No, only devices that meet the transition conditions are eligible.
Are Class A non sterile devices included in the transition extension?
No, these devices should already comply fully with IVDR.
What happens if a manufacturer misses the notified body agreement deadline?
The device may lose eligibility for transition and face removal from the market.
Can manufacturers make design changes during the transition period?
No, significant changes to design or intended purpose are not permitted.
Is EUDAMED registration required for legacy devices?
Yes, legacy devices must be registered by November 2026.
Should manufacturers delay their IVDR submission because of extended timelines?
No, delaying increases the risk of missed deadlines and limited notified body capacity.
