IVDR Deadlines: May 2027 - Time is running out to prepare

IVDR Deadlines: Time is running out to prepare.

For many In-vitro Diagnostics (IVD) manufacturers, the next transition milestones are getting closer than they may seem.

The deadline for legacy Class C IVDs already passed on 26 May this year.

Now, manufacturers of Class B and sterile Class A IVDs should make sure their next steps are fully in place.

Important dates to keep in mind:

• By 26 May 2027 An IVDR-compliant QMS must be implemented, the application to a Notified Body must be submitted, and a written agreement with the Notified Body must be in place.

• By 31 December 2028 The transition period ends for Class C IVDs.

• By 31 December 2029 The transition period ends for Class B and sterile Class A IVDs.

This is a good time to step back:

1. Is your product classification correct?
2. Is your technical documentation complete and up to date?
3. Are your QMS and Notified Body preparations on track?

A realistic gap assessment now can help identify open issues early and avoid unnecessary time pressure later.