New MDCG Guidance document released
New MDCG Guidance document released
Monday, 09 December 2024
Kirsten Van Garsse, Authorized Representative Director & Regulatory Affairs Manager IVD
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On December 2nd, 2024, the Medical Device Coordination Group (MDCG) released a new guidance on the publication of the clinical investigation reports and their summaries in the absence of EUDAMED.
MDCG 2024-15 includes a clarification on the procedure to be followed by the clinical investigation sponsor under Regulation (EU) 2017/745 (MDR) to submit the clinical investigation report and its summary to national competent authorities, and how these documents are managed and stored. In the absence of a similar guidance for device performance studies under Regulation (EU) 2017/746 (IVDR), this guidance is also relevant for IVD performance study sponsors.
Some key takeaways from MDCG 2024-15
The sponsor of a clinical investigation must submit a clinical investigation report within one year of the end of the clinical investigation, or within three months of the early termination or temporary halt, to the member states in which a clinical investigation was conducted. This report must be accompanied by a summary, presented in terms that are easily understandable to the intended user. MDCG 2024-15 clarifies that, in the absence of EUDAMED and in line with MDCG 201-21 Rev.1, the submission must occur to the same competent authority contact used for the application of that investigation, or the contact indicated by the competent authority.
The competent authority will label the documents as ‘CIV-ID – CIR’ (clinical investigation report) and ‘CIV-ID – SCIR’ (summary report), using the CIV-ID that was generated according to MDCG 2021-20, and a tracking file will be generated. The member state which generated the CIV-ID will transmit the documents in unmodified form to the European Commission. The Commission will upload the documents in the dedicated public CircaBC directory one year after their submission to the relevant competent authorities, where they are stored. In cases of early termination or temporary halt, the summary and the report will become publicly accessible immediately after submission.
MDCG 2024-15 is applicable until the use of the CI/PS EUDAMED module becomes mandatory.
What does it mean to you?
MDCG 2024-15 is important for all sponsors (or their legal representatives) of clinical investigations under MDR to understand the procedure from submission to publishing of clinical investigation reports and their respective summaries.
While this guidance is written specifically for clinical investigations under MDR, it is very likely that this approach will be copied for performance studies under IVDR. IVDR Article 73 (5) and (7) are similar to the MDR article 77 (5) and (7) and MDCG 2022-12 contains a similar clause to MDCG 2021-1 with regards to the sharing and publishing of the performance study reports and the respective summary reports via the use of a dedicated publicly available CircaBC directory.
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