Coverage of MDR/IVDR Codes by Notified Bodies: June 2025 report highlights critical areas with low designation

The European Commission has published the updated report on the coverage of designation codes assigned to notified bodies under the MDR (2017/745) and IVDR (2017/746) regulations. This document provides a quantitative overview of the current capacity of notified bodies to assess medical devices and in vitro diagnostic devices, with direct implications for manufacturers undergoing certification or recertification.

Low coverage in strategic areas

The report shows that although many MDR and IVDR codes are widely covered, there are significant gaps in critical categories:

▪ MDR - Medical Devices

• Active implantable medical devices (MDA 0101 to MDA 0104): only 4 to 10 notified bodies have designations for these codes.

• Devices using tissues or cells of human origin (MDS 1002): only 7 bodies cover this category.

IVDR - In Vitro Diagnostics

• Blood and tissue typing devices (IVR 0101 to IVR 0202): covered by only 10 notified bodies.

• Devices requiring knowledge of radioactivity or transmissible agents (IVP 3009, IVD 4003): also with very limited coverage.

Why is this information critical?

Choosing the right notified body is a strategic factor:

• Avoid delays in certification;

• Anticipate limitations in technical capacity or experience;

• Ensure that the chosen body is designated for the product codes applicable to your portfolio.

We support your certification strategy

Smart MDR supports manufacturers in identifying the relevant MDR/IVDR codes, assessing the capabilities of notified bodies, and defining more efficient submission strategies in line with regulations.

Talk to us to assess the regulatory positioning of your product and ensure a safe and effective certification process.

Read the full report below.