Formal Application for Class D and IVDD Devices: key requirements before May 26, 2025
Much has already been said about the importance of UDI-DI implementation and IVDR-compliant QMS.
But if you manufacture Class D devices or devices certified under the IVDD, there’s another critical step you cannot afford to miss.
Submitting a formal application for conformity assessment is essential if you want to continue marketing your devices in the European Union after the transition period.
And the clock is ticking: the deadline is May 26, 2025.
Why a Formal Application matters
Without a formal application officially received by a Notified Body, your devices will lose market access after the transitional period.
It is not enough to start discussions or plan future steps: you must submit a complete, compliant application by the deadline.
This requirement, established under Regulation (EU) 2024/1860, applies to:
- Manufacturers of Class D devices under IVDR.
- Manufacturers of devices still certified under IVDD.
What “Formal Application” really means
A formal application is not a simple contact or preliminary discussion.
It must be a full, documented request for conformity assessment, meeting all IVDR requirements, and officially acknowledged by the Notified Body before May 26, 2025.
Submitting a formal application on time means:
- Keeping your devices on the market without interruption.
- Avoiding costly delays and certification bottlenecks.
- Protecting your market position against competitors.
How to move forward
If you haven’t already started the process, now is the time to act:
- Get in touch with a Notified Body urgently.
- Review and update your technical documentation based on IVDR standards.
- Prepare and submit a formal, complete application.
- Ensure you have confirmation of receipt before the deadline.
Don’t leave it to the last minute
Preparing and submitting a formal application is a crucial step to safeguard your ability to operate in the European market beyond the transitional period.
Starting the process early will help you avoid last-minute risks and ensure business continuity.
For any questions regarding the IVDR formal application process, feel free to contact us.
