Description
Our ready-to-use Clinical Development Plan template is designed to help manufacturers, regulatory consultants, and clinical professionals create a structured and fully compliant document that meets all regulatory expectations.
This template provides a comprehensive framework for outlining your clinical strategy, ensuring that all necessary clinical data is systematically gathered, evaluated, and used to demonstrate safety, clinical performance, and benefit-risk balance—critical elements for obtaining and maintaining CE-marking.
📌 What’s Inside the Clinical Development Plan Template?
1️⃣ Introduction – Overview of the Clinical Development Plan (CDP), its objectives, and its role in supporting the conformity assessment process.
2️⃣ General Information on the Device – Comprehensive details about the medical device, including its intended purpose, classification, and target patient population.
3️⃣ Clinical Investigations Conducted with the Medical Device – Summary of previous and ongoing clinical investigations, including methodologies, key findings, and relevance to clinical development.
4️⃣ Output of Device Clinical Evaluation – Overview of clinical evaluation findings, evidence of safety and performance, and benefit-risk assessment based on clinical data.
5️⃣ Rationale and Strategy for the Generation of Additional Clinical Data – Identification of gaps in clinical evidence and the planned approach for gathering further post-market clinical follow-up (PMCF) data.
6️⃣ Regulatory Considerations – Compliance with EU MDR requirements, Good Clinical Practice (ISO 14155:2020), MEDDEV guidance, MDCG documents, and other applicable regulations.
7️⃣ Quality Considerations – Integration of the clinical development strategy with the device’s Quality Management System (QMS) and risk management process (ISO 14971:2019).
8️⃣ Clinical Development Plan Update – Guidelines on how and when to update the CDP based on new clinical evidence, regulatory changes, or post-market surveillance (PMS) data.
✅ Why Choose This Template?
✔️ Fully Compliant with EU MDR 2017/745 – Aligns with the latest regulatory requirements and Good Clinical Practice (ISO 14155:2020).
✔️ Structured & Easy to Use – Clearly defined sections to help you systematically document your clinical development strategy.
✔️ Saves Time & Ensures Compliance – Avoid the hassle of starting from scratch and ensure your CDP meets MDR expectations.
✔️ Editable & Customizable – Delivered in an editable format so you can tailor it to your specific device and clinical strategy.
