Introduction: Why a Clinical Development Plan Matters
The Clinical Development Plan (CDP) is essential to your device's clinical evaluation under EU MDR 2017/745. It supports comprehensive clinical evidence from feasibility studies to post-market real-world observations.
ISO 14155-compliant CDPs from Bioexcel assist medical device innovators in streamlining regulatory approvals, reducing risk, and assuring continuous learning throughout the device lifecycle.
What Does a CDP Include?
A clinical development plan is a path for gathering evidence that indicates your product is safe, effective, and ready for use, not just a regulatory necessity. Comprehensive CDPs include:
General Purpose & Intended Use
Define how your gadget improves clinical outcomes and who it serves. This concept frames all future research.
Objectives of the CDP
The CDP outlines how the device will move from initial exploratory testing to confirmatory trials, ensuring a smooth, evidence-based transition.
Phase 1: Exploratory Investigations
These early-stage studies provide initial insights into the device’s safety, usability, and feasibility.
- First-in-Human Trials assess basic safety and tolerability
- Feasibility Studies validate use in a clinical environment
- Pilot Studies optimize data collection for pivotal trials
Phase 2: Confirmatory Investigations
This phase includes pivotal clinical trials designed to rigorously evaluate:
- Safety and clinical performance
- Effectiveness in the intended population
- Patient-reported outcomes and quality of life
All trials follow strict inclusion/exclusion criteria and utilise validated endpoints to meet regulatory expectations.
Phase 3: Post-Market Clinical Follow-Up (PMCF)
Even after your device reaches the market, the CDP continues with a PMCF strategy to:
- Monitor long-term safety and performance
- Detect rare or delayed adverse events
- Support future labeling, improvements, or indications
Our PMCF designs are multicenter, prospective, and tailored to real-world data collection.
Timelines & Milestones
Each phase of the CDP includes projected start and end dates, ensuring:
- Proactive project planning
- Better site and resource management
- Timely data collection and reporting
We help you stay on track, from the first patient in to the final submission.
Acceptance Criteria & Data Analysis
For each phase, Bioexcel defines clear success metrics:
- Safety thresholds in exploratory trials
- Efficacy endpoints in pivotal studies
- Protocol adherence and data integrity in PMCF
We also guide statistical methodology, regulatory reporting, and communication with Notified Bodies.
🎯 Why Choose Bioexcel for Your CDP?
- We’re not just document writers—we’re your strategic CRO partner.
- End-to-end support from study design to CE marking
- ISO 14155:2020 and MDR 2017/745 expertise
- Global experience with IVDs, SaMD, implants, and AI-powered devices
💬 Let’s Plan Your Clinical Success
A clinical development plan is more than compliance—it's your product’s passport to market success. Partner with Bioexcel to get it right the first time.
Bioexcel – Where Innovation Meets Evidence.
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