European Commission Publishes 2025 Member State Summaries on Notified Body Monitoring
The European Commission has published the Member State summaries of the annual reports for 2025 concerning the monitoring and on-site activities regarding notified bodies.
The summaries relate to oversight activities under Article 44(12) of the MDR and Article 40(12) of the IVDR.
Scope of the Summaries
The document lists the Member States for which summaries are available and indicates whether the information relates to the MDR, the IVDR, or both.
According to the table, MDR summaries are available for all listed Member States, while IVDR summaries are available for selected Member States.
Member States Covered
The listed Member States include Austria, Belgium, Croatia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Hungary, Ireland, Italy, Netherlands, Norway, Poland, Slovakia, Slovenia, Spain and Sweden.
IVDR summaries are indicated as available for Austria, Belgium, Finland, France, Germany, Ireland, Italy, Netherlands, Norway and Slovakia.
For other listed Member States, the IVDR column is marked as N/A.
Relevance for Manufacturers
For medical device and IVD manufacturers, notified body monitoring is an important part of the MDR and IVDR oversight framework.
These summaries may provide useful visibility into how national authorities monitor notified bodies and conduct on-site activities.
Manufacturers should pay attention to:
notified body oversight under the MDR and IVDR;
Member State monitoring activities;
availability of MDR and IVDR annual summaries;
differences in IVDR reporting availability across Member States;
potential implications for conformity assessment oversight;
broader transparency around notified body supervision.
Impact on Medical Device and IVD Manufacturers
For manufacturers relying on notified bodies for MDR or IVDR conformity assessment, these summaries are relevant because they support transparency around how notified bodies are monitored by Member States.
They may help manufacturers better understand the regulatory oversight environment in Europe and follow developments related to notified body supervision, capacity and compliance expectations.
