The Importance of Clinical Investigation Planning Under MDR
When preparing to bring a medical device to market under MDR (EU 2017/745), one of the most critical steps is the planning of your clinical investigation. Regulatory authorities require manufacturers to demonstrate both safety and clinical performance, and the path to fulfilling those requirements begins with a solid foundation: a well-structured Clinical Investigation Plan (CIP).
At MDS, we understand that clinical investigations can be complex, with regulatory, operational, and strategic components that must align. That’s why early-stage planning is not just helpful—it’s essential. As your Contract Research Organization (CRO) partner, we provide the expertise to ensure your study starts on the right foot.
What Makes a Strong Clinical Investigation Plan (CIP)?
The CIP is the cornerstone of any clinical investigation. It outlines the study design, methodology, objectives, and the data analysis plan. A well-developed CIP ensures that your study is both scientifically sound and compliant with MDR and ISO 14155 requirements. Effective planning through the CIP allows you to:
- Select the most appropriate study design and clinical endpoints.
- Define clear objectives that align with regulatory expectations.
- Anticipate potential risks and incorporate strategies to mitigate them.
- Allocate resources efficiently by mapping out timelines and responsibilities.
Planning also involves identifying whether the clinical investigation is even feasible in the intended population and setting. This step, known as feasibility assessment, ensures that the trial is logistically sound and has the best chance of delivering meaningful, compliant data.
The Role of a CRO in Clinical Investigation Planning
Navigating the regulatory requirements of MDR can be overwhelming without the right support. That’s where partnering with a CRO like MDS becomes invaluable. We offer comprehensive planning services that help you:
- Develop your Clinical Investigation Plan and related documentation.
- Create an Investigator’s Brochure that clearly communicates device details to clinicians.
- Ensure protocol design aligns with ISO 14155 and ethical standards.
We also provide consultation to ensure your strategy is tailored to your specific device and its risk classification, market goals, and clinical needs.
Start Strong with Expert Support
Effective clinical investigation planning helps prevent costly delays, reduces regulatory risk, and builds confidence in your device’s clinical development pathway. With MDS as your CRO partner, you gain a trusted advisor who understands the regulatory landscape and knows how to guide you through the early phases of clinical research.
In our next post
We’ll explore the essential documentation needed for clinical investigations and how a CRO helps manage and maintain these materials to ensure compliance throughout the study!