Bringing a medical device to the European market requires more than innovative technology — it demands meticulous documentation and clear evidence of safety and performance. Under the EU Medical Device Regulation (MDR 2017/745), your Technical File and Clinical Evaluation Report (CER) form the backbone of your CE marking application.
At MDS, we guide manufacturers through every step of this process, helping ensure your documentation is structured, compliant, and ready for review by your Notified Body.
The Technical File: The Core of Compliance
A well-prepared Technical File is essential to demonstrate that your device meets all applicable safety and performance requirements. It’s not just a collection of documents — it’s a structured body of evidence that defines your device’s lifecycle, from design and manufacturing to verification, validation, and post-market surveillance.
Our team supports you by:
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Structuring and compiling Technical Documentation tailored to your device type and risk classification.
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Preparing core documents such as the device description, GSPR checklist, usability and risk management files, verification reports, and post-market plans.
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Ensuring MDR alignment through gap analysis, document standardization, and harmonized template systems.
With MDS, your Technical File is not only complete but organized for clarity — helping reviewers find key information efficiently and minimizing the risk of delays.
The Clinical Evaluation Report: Demonstrating Safety and Performance
Your device’s Clinical Evaluation Report (CER) is where regulatory expectations meet real-world evidence. It consolidates clinical data, literature reviews, and post-market findings to demonstrate that the device performs as intended and provides measurable clinical benefits.
At MDS, we help you:
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Develop a Clinical Evaluation Plan (CEP) that defines search strategies, data appraisal criteria, and State of the Art analysis.
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Conduct systematic literature reviews to gather and evaluate evidence that supports your device’s intended purpose.
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Prepare a CER that integrates all available clinical data in line with MDR and MEDDEV 2.7/1 Rev. 4 guidance.
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Continuously update your CER as part of your post-market surveillance obligations.
Our expertise ensures your clinical evaluation not only meets MDR requirements but also builds a strong foundation for future audits and market expansion.
Why Partner with MDS for CE Mark Preparation?
We combine technical depth with practical experience across the full regulatory pathway. Whether you are developing your first MDR submission or updating legacy documentation, our team helps you navigate complexity efficiently.
By partnering with MDS, you benefit from:
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Streamlined documentation processes and clear structure.
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In-depth clinical and regulatory expertise.
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Tailored support for startups and established manufacturers alike.
Achieve Confidence in Your CE Mark Journey
Securing the CE mark is a defining milestone for any medical device company — and the right documentation strategy can make all the difference. At MDS, we help you align every element of your technical and clinical documentation with MDR requirements, reducing uncertainty and accelerating your path to market.
Contact us at Kristian@mdsdenmark.dk or schedule a consultation via Book a Meeting to talk about your CE-marking strategy!