Manufacturers encountering delays with EUDAMED’s Clinical Investigations module can now utilize a newly established European Commission resource to store essential clinical investigation reports and summaries.
Interim Solution via CIRCABC Directory
Due to the unavailability of EUDAMED’s Module 6, sponsors who have completed clinical investigations must adhere to Article 77(5) MDR by submitting their reports and summaries to the CIRCABC directory. This dedicated public repository, titled “MDR Clinical Investigation reports and their summaries,” is accessible through a specific European Commission link, ensuring compliance while the primary module remains offline.
Submission Process and Future Integration
Sponsors are required to file their documents with the Competent Authorities in the Member States where the investigations were conducted. These authorities verify that the reports are correctly uploaded to the CIRCABC page, making them publicly available. Once EUDAMED’s CI/PS module becomes operational and mandatory, the CIRCABC directory will be phased out, necessitating a full transition to the official platform.
• Ensures ongoing compliance with MDR requirements despite EUDAMED delays
• Enhances transparency by making clinical reports publicly accessible
• Highlights the European Commission’s proactive approach to regulatory challenges
• Requires coordination between sponsors and local Competent Authorities
The creation of the CIRCABC directory demonstrates the European Commission’s dedication to upholding regulatory standards amidst technological setbacks. By providing an alternative repository, the Commission ensures that clinical investigation data remains accessible and compliant with MDR obligations. This measure not only maintains trust in the regulatory framework but also facilitates continuous progress in medical device oversight. Stakeholders should prepare for a seamless transition to EUDAMED’s Module 6 by staying informed about its deployment timeline and requirements. Understanding the interim procedures and future expectations will equip manufacturers to manage their clinical data efficiently, ensuring uninterrupted adherence to European medical device regulations.
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