Class C IVD manufacturers: Only one month left – Don’t lose EU market access

The deadline for transitioning legacy Class C IVDs is fast approaching. Manufacturers of devices that were self-declared under the IVDD but are now classified as Class C under the IVDR need to take urgent action to avoid losing market action. To take advantage of the extended transition period until 31 December 2028, they must submit their formal applications to an EU Notified Body no later than 26 May 2026 This requirement is in accordance with Article 110(3c)(e) of the IVDR [as amended by Regulation (EU) 2024/1860].

Under the IVDR, Class C IVDs now require Notified Body involvement for conformity assessment, marking a significant change from the IVDD self-declaration route. To avoid disruption to patient care and supply chains, the European Commission introduced extended transitional periods for “legacy” devices lawfully placed on the market before 26 May 2022.

For these legacy Class C devices, market access can continue until 31 December 2028, provided the conditions set out in Article 110(3c) are met, most notably, the timely submission of a formal application to a Notified Body.

 

This table summarizes the key deadlines applicable to Class C self-certified IVDs:

Milestone	Date	What it means
IVDR-compliant QMS	26 May 2025 (already passed)	A fully implemented and operational quality management system in line with IVDR requirements
Formal application to an EU Notified Body	25 May 2026	Deadline for manufacturers to submit a signed and dated formal application to an EU Notified Body
Signed written agreement with a Notified Body	Before 26 September 2026	A formal contract must be in place between the manufacturer and the Notified Body
Full IVDR certification and compliance	Before 31 December 2028	Legacy Class C IVD must have received IVDR certification from the Notified Body

 

Beware of these common pitfalls

To ensure a smooth and timely submission, pay close attention to these common pitfalls:

• Misclassified devices - double-check and confirm your IVDR classification rationale
• Incorrect transition timelines - confirm which devices genuinely qualify as legacy devices under Article 110
• Late engagement - delaying action significantly increases the risk of missed deadlines, delays, or loss of eligibility

At DNV, our dedicated IVD team has extensive experience with Class C devices and is ready to help you meet the 26 May 2026 deadline efficiently. We offer Structured Dialogues to address topics such as:

• Clarification calls to answer any questions about your portfolio
• A guided walk-through of the formal application documents

The 26 May 2026 deadline to submit your formal application is fixed. If your Class C IVDs are still self-declared under the IVDD and you have not yet engaged with a Notified Body, now is the time to act.

We have experts across the world ready to support you. Contact us today to arrange a no-obligation discussion. We will quickly review your situation and help you protect EU market access.

 

DNV hosting an IVDR "Ask Me Anything" online webinar

We are hosting an IVDR “Ask Me Anything” session, an informal, interactive space to ask your questions and hear from peers across the industry. You may gain insights into challenges and considerations you hadn’t previously encountered.

Register now to join on 12 May 2026, there are two sessions to choose from 10am CET or 6pm CET. We look forward to supporting you through this final phase of the IVDR transition for self-certified Class C IVDs.

• Register here

 

 

4/29/2026 6:29:00 AM