European Commission Updates Notified Body Standard-Fee List Under MDR and IVDR

The European Commission updated its consolidated list of links to Notified Body standard-fee schedules on 13 July 2026 under the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Device Regulation (IVDR). The update gives manufacturers centralized access to publicly available certification fee information to support budgeting and Notified Body selection.

What changed?

The European Commission published an updated consolidated list linking to the standard-fee schedules made available by Notified Bodies designated under the MDR and IVDR. By bringing the links together in one place, the list makes it easier for manufacturers to locate official fee information before beginning conformity assessment activities.

Why are standard-fee schedules published?

Under Article 50 of the MDR and Article 46 of the IVDR, designated Notified Bodies must establish lists of their standard fees for the conformity assessment activities they carry out and make those lists publicly available.

The Commission's consolidated list supports that transparency requirement by providing a central directory of the fee schedules published by individual Notified Bodies.

Key benefits for manufacturers

The updated list can help medical device and IVD manufacturers with:

• Easier access to published standard-fee schedules.
• More informed planning for MDR and IVDR certification projects.
• More realistic conformity assessment budgets.
• Comparison of fee structures across designated Notified Bodies.
• Selection of a Notified Body based on designation scope, project needs, capacity, service, and cost.

Regulatory basis

The publication aligns with:

• Article 50 of Regulation (EU) 2017/745 on medical devices (MDR).
• Article 46 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

These provisions require designated Notified Bodies to make their standard fees publicly available. MDCG 2023-2 also provides a scope and template for standard-fee lists.

What this means for manufacturers

Manufacturers preparing for MDR or IVDR conformity assessment can use the updated list as a planning resource. Access to the published schedules can help companies:

• Develop more accurate certification budgets.
• Compare fee structures among designated Notified Bodies.
• Improve financial planning before submitting certification applications.
• Ask better-informed questions during the Notified Body selection process.

Published standard fees are only one consideration. Manufacturers should also confirm that a Notified Body has the appropriate designation scope and evaluate its availability, technical expertise, timelines, and service model. Actual project costs may vary according to the device, assessment scope, audit requirements, and other project-specific factors.

Key takeaways

• The European Commission updated the consolidated list of Notified Body standard-fee schedules on 13 July 2026.
• The list covers Notified Bodies designated under the MDR and IVDR.
• It centralizes links to fee information that Notified Bodies make publicly available.
• Manufacturers can use the list to support budgeting and cost comparisons, alongside scope and service considerations.

Conclusion

The updated consolidated list improves access to Notified Body fee information for manufacturers planning MDR and IVDR certification. Used together with designation-scope, capacity, timeline, and expertise checks, it can support more informed conformity assessment planning.

Read the European Commission announcement and download the updated fee list, or learn more about EU medical device and IVD regulation.