IVDR Class C Transition: Are You Ready for May 26, 2026?

Welcome back to reality!

While we were all winding down for Christmas, the clock didn't stop ticking on the IVDR transition.

If you manufacture a Class C IVD (think companion diagnostics, cancer screening, genetic testing), May 2026 isn't just "springtime." It’s your deadline.

By 26 May 2026, you must have lodged a formal application with a Notified Body to keep your legacy devices on the market under the extended transition period.

The trap?
You can't just email a Notified Body in May and hope for the best.
Review cycles, contract negotiations, and scope verification take months. If you haven't started that conversation today, you are already behind.

Don't risk your market access.

If you’re an SME staring at this deadline and wondering where to start, DM me. We need to look at your technical documentation status now, not in April.

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