Clinical Evaluation
In the European Union, conducting a thorough Clinical Evaluation is mandatory for obtaining and maintaining CE marking under the EU MDR 2017/745. It’s not just a document—it’s the scientific backbone of your technical file, demonstrating that your device is safe, effective, and aligned with the current standard of care.
We help medical device manufacturers build strong, MDR-compliant clinical evaluation documentation. From the Clinical Evaluation Plan (CEP) to the final Clinical Evaluation Report (CER), our approach follows MEDDEV 2.7/1 rev. 4 and MDCG guidance, so your company can have clarity, consistency, and strategic alignment with regulatory expectations.
How We Support Your Clinical Evaluation
Our clinical evaluation services are tailored to the specifics of your device, your data, and your market pathway:
Clinical Evaluation Plan (CEP): We develop a structured, device-specific CEP that defines the objectives, scope, methodology, and sources of clinical data to be used throughout the evaluation process. This plan serves as the foundation for a compliant CER.
Literature Review: Identify relevant clinical data on comparable devices. Support performance and safety claims with robust evidence.
Clinical Evaluation Report (CER): We compile and critically analyze all available clinical data—published literature, clinical investigations, and post-market data—to demonstrate that your device meets the General Safety and Performance Requirements (GSPRs) of MDR.
We simplify the complexity of Clinical Evaluation. Instead of leaving your team to navigate vague guidelines and regulatory jargon, we offer structured support, expert documentation, and clear strategies tailored to your device.
Why do you need this service?
Whether you’re launching a new device or updating existing documentation, we create clinical evaluation content that satisfies MDR 2017/745 requirements.
We help map clinical evidence to the relevant requirements, avoiding gaps that could delay CE marking.
Already have CE marking? We support post-market clinical follow-up (PMCF) strategies and periodic updates to your CER.
Working with Sobel means less guesswork, fewer delays, and more focus on what really matters: getting your device to market. Our expertise turns scattered data into a cohesive, MDR-ready narrative that saves you time, avoids rework, and keeps your compliance process smooth from start to finish.
Need Expert Support with Your Technical File?
From plan to report, we provide structured, regulatory-ready clinical evaluations that bring clarity to your CE marking process. We guide your strategy and documentation with the precision regulators expect.
Let Sobel help you build compliant, effective documentation—tailored to your device and aligned with MDR expectations.
Structured, Compliant, and MDR-Ready!
