The MDR describes in Annex XIV the requirements for the clinical evaluation plan, and therein, the clinical development plan is also mentioned. It is intended to outline the progression from exploratory investigations, such as first-in-man studies, feasibility, and pilot studies, to confirmatory investigations, such as pivotal clinical investigations.
The correlation between Clinical Development Plan and Clinical Evaluation Plan
The CEP delineates the clinical approach that manufacturers must adhere to in justifying the safety and efficacy of their device, aligning with the General Safety and Performance Requirements (GSPR) of the MDR. Within this framework, CDP serves as a subset of CEP, specifically honing in on clinical investigations for the device in question, which may fall under one of the following categories:
- Previously conducted investigations, ideally supported by a comprehensive clinical investigation report.
- Ongoing investigations accompanied by a complete clinical investigation protocol.
- Planned future investigations, encompassing pilot, pivotal, or PMCF studies. It is preferable for a synopsis of such studies to be integrated into the CDP.
The Clinical Development Plan in the Clinical Evaluation Plan
The ISO 14155 on Clinical investigation of medical devices for human subjects is the playbook for your clinical team. Annex I lists the stages of clinical development and explains the difference between pilot, pivotal, and PMCF clinical investigations. The CDP can be presented in a tabular form or written in paragraphs as a subchapter of your CEP. It helps the reviewer to understand the clinical studies you conducted and helps you to keep an overview of existing and missing clinical data for your device.
Usually it answers the following questions:
- What kind of clinical investigations have been conducted with your device (PMCF study, pilot study…)
- Which type of study has been conducted (non-randomized vs. randomized)?
- What are exclusion and inclusion criteria?
- Which clinical endpoints and acceptance criteria did you define?
- Do you plan off-label use studies for your device?
In a nutshell: Describe the background and goals of your studies and why you performed them or will conduct them.
What the MDCG says
The MDCG 2020-13 aka the clinical evaluation assessment report template for notified bodies mentions the CDP and provides the interesting statement “A detailed description of the clinical development plan is not required for the purpose of this template unless there are specific concerns.”.
I interpret this in the way that the NBs will not assess the CDP in all detail and only check if it is in place and if you provided a justification in case you have no clinical data.
What to do
If you have clinical data before you submit your technical documentation, summarize it in a structured way and label it as CDP in your CEP. Make sure you align your clinical claims with the clinical study in an early stage of planning. Despite the limited mention of the term “Clinical Development Plan” in the MDR, it’s important to recognize the role this tool plays in improving the quality of technical and regulatory documentation.
