MDCG 2014-15 Guidance on Clinical Investigations
This document, issued by the Medical Device Coordination Group (MDCG), provides guidance on the publication of clinical investigation reports and their summaries in the absence of the EUDAMED database. It aligns with the requirements of the EU Medical Device Regulation (MDR) 2017/745, specifically Article 77(5) and (7).
Key Points:
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Submission Requirements:
- Sponsors must submit clinical investigation reports and summaries to the Member States where the clinical investigation was conducted.
- These submissions must occur within one year of the clinical investigation’s conclusion, or within three months if it is terminated early or temporarily halted.
- Reports and summaries must be presented in terms that are easily understandable to the intended user.
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Publication Timelines:
- Reports and summaries will become publicly accessible via EUDAMED at the latest when the device is registered (Article 29) or within one year if not registered.
- In cases of early termination or temporary halt, reports and summaries will become publicly accessible immediately after submission.
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Temporary Procedures Without EUDAMED:
- Until EUDAMED is fully functional, submissions will follow national procedures as outlined in MDCG 2021-1 Rev. 1.
- Reports and summaries will be shared through the public CIRCABC directory.
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Submission and Management:
- Sponsors are responsible for submitting unredacted documents to competent authorities and ensuring confidentiality and data protection.
- Competent authorities will label the documents using CIV-ID (a unique identification number) and transmit them to the European Commission.
- The Commission will store and publish the documents in the CIRCABC directory one year after submission, unless earlier publication is required due to early termination or temporary halt.
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Tracking and Accessibility:
- A tracking file will log details such as the investigation title, sponsor details, funding entity, CIV-ID, and investigation status.
- Reports and summaries will be stored in a dedicated public CIRCABC directory, which will be accessible to all without membership requirements.
- Member States and the European Commission will publicise the directory link.
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Document Validity:
- The guidance will remain valid until the mandatory use of the EUDAMED CI/PS module.
How Med-Di-Dia Can Assist
Navigating MDR compliance and clinical investigation reporting requirements can be a complex and time-consuming process. Med-Di-Dia provides expert regulatory and quality compliance support to ensure your clinical investigation processes are seamless and fully compliant with EU regulations. Our services include:
- Clinical Investigation Guidance: Assisting in the preparation and submission of clinical investigation reports and summaries in compliance with MDR Article 77 and MDCG guidance.
- Regulatory Strategy Development: Developing tailored strategies for transitioning from national procedures to EUDAMED requirements, ensuring smooth compliance.
- Technical Documentation Support: Comprehensive review and preparation of technical documentation to meet EU and global regulatory standards.
- Post-Market Surveillance and Vigilance: Expertise in post-market requirements to ensure your devices remain compliant after launch.
- EU Authorised Representative (EUAR) Services: Acting as your local representative for seamless regulatory communications.
Our team specialises in simplifying complex regulatory pathways, enabling you to focus on innovation and growth. Partner with Med-Di-Dia to streamline your compliance journey and achieve faster market access.
For more information, send us an email at mdd@mddltd.com or visit us at www.med-di-dia.com or contact us to schedule a consultation. Let us handle the compliance while you focus on delivering exceptional medical device solutions.
