A study to monitor the availability of medical devices

On July 3, 2026, the Commission published a new set of documents, including the results of the 20th survey of notified bodies and the 3rd survey of manufacturers, authorized representatives, and other economic operators. The purpose of this study is to regularly assess whether the requirements introduced by the MDR and the IVDR are having an impact on the availability of medical devices within the European Union.

To this end, several categories of stakeholders are surveyed periodically:

• notified bodies;
• manufacturers;
• agents;
• other economic operators;
• health care facilities.

The information collected enables the European Commission to monitor market developments and quickly identify any potential issues that could affect the availability of medical devices.

Notified bodies continue to expand their operations

The results of the 20th survey show that notified bodies continue to expand their certification capabilities.

The number of MDR and IVDR certificates issued is steadily increasing, and notified bodies are processing a growing volume of certification applications.

This development confirms that the European system is gradually maturing. The numerous designations of notified bodies that have taken place since the MDR came into effect are now helping to improve the system’s overall capacity.

However, the workload remains heavy, and certification lead times can still be lengthy, particularly for the most complex devices.

The quality of technical documentation remains a key factor

The survey results also highlight that the duration of the evaluations depends heavily on the quality of the submitted applications.

Incomplete files, insufficiently substantiated clinical data, or late responses to requests for additional information from notified bodies can significantly prolong the certification process.

This observation underscores the importance of preparing a robust technical dossier in advance that complies with the requirements of the MDR or the IVDR.

Manufacturers continue to report several challenges

The third survey of manufacturers and other economic operators highlights several ongoing concerns.

Among the most frequently cited challenges are:

• the complexity of regulatory requirements;
• the cost of certification procedures;
• the human and financial resources necessary to achieve compliance;
• the time required to obtain certificates;
• the specific challenges faced by small and medium-sized enterprises.

Although the situation is gradually improving, regulatory transition remains a major challenge for part of the European industry.

An Interactive Dashboard to Track Market Trends

One of the most interesting contributions of this study is the availability of an interactive dashboard developed by the European Commission.

Available for free online, this dashboard tracks a wide range of indicators related to the availability of medical devices on the European market.

In particular, it allows you to view:

• the number of MDR and IVDR certificates issued;
• trends in certification applications;
• the capabilities of notified bodies;
• the main findings of the surveys conducted among manufacturers and notified bodies;
• Various indicators for assessing the transition to the MDR and IVDR regulations.

Explore the Interactive Dashboard

What lessons can manufacturers learn from this?

The results published by the Commission show that the transition to the MDR and the IVDR is progressing steadily.

However, manufacturers must continue their efforts to plan for their recertification well in advance and prepare complete technical dossiers from the very first submission.

A proactive regulatory strategy not only reduces certification lead times but also minimizes the risk of delays in bringing a product to market.