The transition to IVDR is entering its final phase, and the clock is ticking for Class C IVD manufacturers. Under the IVDR, Class C devices now require assessment by a notified body. It is a major shift from the IVDD where no such review was required. To ensure market continuity, you must submit your application to a notified body before May 26, 2026 and have a signed contract in place by September 2026.

If you haven’t started yet, the time to act is now. The closer we get to these deadlines, the tighter notified body capacities will become.

Why this matters now:

• IVDR compliance is mandatory for continued CE marking after the transition period.
• Notified bodies are already seeing an increased amount of applications; last-minute requests can mean ending up in a large pile or even missing the review window[K(1] .
• Incomplete or poor-quality submissions can lead to costly back-and-forth reviews and lost time, as well as increased cost for notified body reviewer’s time.

Key questions to ask right now:

• Have you contacted one or more notified bodies with IVDR designation and the right scope for your devices?
• Do you understand what documentation must accompany your application? Many get delayed due to incomplete applications.
• Have you started compiling your technical documentation, including performance evaluation, risk management, and post-market surveillance plans?
• Do you know where your gaps are, and do you have a plan to close them in time for May?

How to prepare: a practical action plan:

1. Engage with notified bodies now
   Confirm that your selected notified body covers your device type and intended use and ask about acceptance timelines and prices. Make sure you understand which documentation is needed as part of the application.
2. Assess your readiness
   Audit your technical documentation against IVDR requirements to identify missing or outdated elements.
3. Run a gap analysis
   Map out what needs remediation, whether it’s analytical or clinical performance evidence, risk evaluation, or other performance data, and assign owners.
4. Develop a remediation timeline
   Work backward from your planned submission date, include time for internal review, and document updates and additional verification testing. Consider which additional data can be collected from post-market activities such as post-market performance follow-up studies or systematic literature reviews.
5. Submit a complete, high-quality application
   Ensure all sections are consistent, traceable, and easy for the notified body to assess. The total notified body review process may take 12 to 18 months.
6. Finalize your contract by September 2026
   Once accepted, finalize the agreement with your notified body to secure your place in the conformity assessment process.
7. For first time submissions, discuss with your notified body the time slot for the IVDR QMS certification audit. Identify any gaps with the requirements stated in IVDR article 10.8 and Annex IX.
8. Agree on the review time slot with your notified body and submit your technical documentation for review. Make sure all parts of the technical documentation are clear and easy to understand for the notified body technical experts. Keep in mind it may take 12-18 month to finalize the review process and before the CE certificate is issued.

Why expert support matters

Involving regulatory experts early saves money and time by preventing multiple review rounds. A complete “one-time-right” application allows you to move through the process faster and avoid the frustration of rework later.

How we can help

We support IVD companies to:

✅ Prepare and submit complete applications to notified bodies

✅ Review existing technical documentation and identify IVDR gaps

✅ Build a focused remediation plan

✅ Engage effectively with notified bodies from day one

✅ QMS gap assessment for IVDR and implementation of mitigation activities including IVDR mock-audits

Our goal: “One‑time‑right”—a clean, concise, and compliant submission and conformity assessment process that accelerates your transition and reduces unnecessary costs.

Don’t wait until May to start your preparation.
Reach out to Qserve today to start your IVDR readiness review and make sure your application is ready to submit well before the May 26, 2026 deadline.

Let’s make your transition to IVDR smooth, strategic, and successful.