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EU Regulation - MDR/IVDR July 2026
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Click on the title of the "documents" to be redirected to the original website. In the "Summary" column, we've included the key information to help you determine whether the topic is relevant to your products. Enjoy reading!
| Documents | Summary |
|---|---|
| Monitoring of Notified Bodies: New MDR and IVDR Reports |
The Commission has published the Member States’ summaries of the 2025 annual reports on the monitoring and supervision activities of Notified Bodies pursuant to Article 44(12) of the MDR and Article 40(12) of the IVDR. The reports provide an overview of the supervisory activities carried out by the designating authorities, including monitoring activities and on-site evaluations of Notified Bodies. |
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The Commission has updated the list of links to the standard fees published by Notified Bodies for MDR and IVDR services. The list does not harmonize or set the fees, but it makes it easier for manufacturers to access public information on the indicative costs of certification services. |
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Study supporting the monitoring of the availability of medical devices on the EU market |
The Commission has published new documents as part of the study monitoring the availability of medical devices on the EU market, including updates related to surveys of Notified Bodies and economic operators. The dashboard was updated to version 3.5 in July. The study supports the monitoring of the impact of the MDR/IVDR transition on the availability of devices. |
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