A CER Clinical Evaluation Report is not just a regulatory requirement, it is a strategic document which supports the safety and performance of your medical device. Under the EU MDR 2017/745, a well-structured and evidence-backed CER is essential for securing CE marking documentation and maintaining post-market compliance.
At Elexes, our regulatory consultants specialize in preparing MDR-compliant CERs that withstand scrutiny from Notified Bodies and regulatory agencies. From initial planning to literature review, data analysis, and periodic updates, we help you meet all necessary expectations.
⦿ Ensure compliance
⦿ Strengthen clinical evidence
⦿ Avoid costly delays
The EU MDR has significantly raised the bar for clinical evidence. A strong EU MDR clinical evaluation report is now a linchpin of the technical documentation and essential for CE Marking.
Elexes’ team supports clients from Class I to Class III medical devices and in-vitro diagnostics (IVDs), developing robust CERs that align with MEDDEV 2.7/1 Rev. 4 and Annex XIV Part A of EU MDR. Whether it’s leveraging literature, post-market surveillance data, or real-world clinical results, we provide strategic insight to present a compelling clinical argument.
Elexes also offers related services such as:
We understand that no two devices are the same. That’s why our CERs, are tailored to your device’s risk classification, intended use, and available data.
Our process includes:
⦿ Defining the scope and identifying equivalence (if applicable)
⦿ Conducting comprehensive literature searches using curated databases
⦿ Extracting and analyzing relevant clinical data
⦿ Evaluating safety, performance, and risk-benefit profile
⦿ Aligning with PMS and PMCF data
⦿ Drafting, reviewing, and finalizing a Notified Body-ready CER
All our CERs are built to integrate seamlessly with your Technical File or Design Dossier, ensuring a smoother CE Marking pathway.
Our expert-driven process ensures your CER meets both technical and strategic regulatory goals. Here's how we do it better:
Understanding the CER journey can simplify your compliance planning. These infographics help break down the pathway and highlight Elexes’ role at each step.
Secure your device’s market entry with a compliant, audit-ready clinical evaluation report. Let Elexes simplify the process for you.
Yes. All Class I to III medical devices must have a CER to support CE Marking.
Depending on device risk and clinical data, it should be updated periodically or when significant changes occur.
Absolutely. We offer integrated services for CER, PMCF, and PMS planning to streamline EU MDR compliance.
It should follow MEDDEV 2.7/1 Rev. 4 guidance and MDR Annex XIV Part A structure.
Yes. We provide detailed responses and evidence to address reviewer questions during CE Marking reviews.
Elexes offers a globally recognized ISO 13485 certification consultant who is renowned to enhancing your business credibility in the medical devices industry.
Our presence across the globe ensures audits are conducted by local-language auditors, facilitating clear communication and understanding.
Our experts provide guidance and consultants to help you adhere to necessary regulations, ensuring your products meet all legal requirements and is compliant to all necessary standards.
At Elexes, we offer to assist in securing additional local certifications, enabling you to manufacture and sell medical devices in various markets across the globe.
We offer complete confidentiality to all our clients which makes us one of the most trusted regulatory and quality compliance consulting.
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CEO Novasignal, Los Angeles
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