A valid Class C application is necessary to maintain your transitional timeline — but it is not, by itself, sufficient to achieve certification
The May 26, 2026 deadline for Class C legacy device applications under EU IVDR – 2017/746 is not an administrative formality. It is a deadline for legacy devices that fall within Class C. Manufacturers must make an application to a Notified Body (NB) by this date to maintain transitional period protection and continued market access. Meeting this submission alone does not immediately guarantee continued market access.
Under the IVDR transitional provisions, a Notified Body (NB) application must pass administrative screening before it is considered valid. If after the May deadline a written agreement is not concluded by September 26, 2026 for Class C, the conditions of Article 110(3c)(f) are not met and the transitional period ceases. The practical consequence is potential immediate market exit for any affected device.
This article covers what constitutes a complete and acceptable NB application under IVDR, the specific documentation and QMS requirements NBs apply during administrative review, and the regulatory consequences of a non-valid submission.
The application and the conformity assessment are not sequential phases — they are parallel workstreams.
Manufacturers who treat them as sequential may not complete certification within the transitional window.
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