The MDCG published a “guidance on the content of the Clinical Investigation Plan for clinical investigations of medical devices” and a Word version Clinical Investigation Plan Synopsis Template. The PDF version of the template is also available as an Appendix within MDCG 2024-3.
The guidance is available here and the Word version template is available here.
MDCG 2024-3 was developed by the National Competent Authorities, industry and relevant stakeholders.
It is intended to support sponsors by providing greater detail on what is expected in each section of the Clinical Investigation Plan (CIP). And help pre-empt questions from the competent authorities during their assessment of the application, i.e., allows sponsors to proactively provide the information the authorities expect to see in the CIP.
While it is not legally binding, and therefore not mandatory, it should be considered best practice. Following it can help ensure a smoother process for all parties.
The Clinical Investigation Plan (CIP) is expected to be:
Therefore, it is preferred that all necessary information be included in the CIP itself. If any required information must be contained in a separate document, then the CIP should summarize and reference this document. Further, the separate document(s) should be submitted together with the CIP as a single submission.
The MDCG guidance covers each section individually and advises on the type and level of content expected.
The 21-page guidance expands on each of the above topics and subtopics. For example:
Subsection 3.3.2 Risks: it is not necessary to include specific mitigations for risks that are determined to be negligible due to a low probability of occurrence and low severity of harm. However, it is expected that all possible risks are identified. This section also provides examples of how clinical investigation design can contribute to risk mitigation, e.g., the use of pre-specified stopping rules.
Section 3.8 Data Management: the measures to be implemented in case of a data security breach (as required under MDR, section 4.5, chapter II, Annex XV) could be placed in this section. Or if provided in a separate document, cited in this section of the Clinical Investigation Plan.
Please refer to the guidance document for a full overview of recommendations.
The PDF version is available as Appendix A within the MDCG guidance. A separate Word (editable) version was also provided by the MDCG, which was linked at the start of this post.
Below is image of the contents for reference.