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Medical Device Clinical Evaluation Report (CER) Services for EU MDR Compliance
In today’s highly regulated medical device landscape, clinical evidence is the backbone of product safety and performance validation. Whether you're introducing a new medical device to the market or maintaining compliance for an existing product, a well-structured Clinical Evaluation Report (CER) is essential for regulatory approvals and continued market access, especially in the EU under MDR 2017/745.
At Elexes Medical Device Consulting, we offer complete end-to-end CER development and support. From gap assessments and literature reviews to PMCF planning and notified body response, our team of clinical and regulatory experts helps you navigate the complexities of CER requirements seamlessly.
What is a Clinical Evaluation Report & Who Requires It?
A Clinical Evaluation Report (CER) is a regulatory document that presents the clinical evidence supporting the safety, performance, and intended purpose of a medical device. It draws on data from clinical investigations, scientific literature, and post-market surveillance to demonstrate compliance with General Safety and Performance Requirements (GSPRs).
Clinical evaluation is not a one-time task—it’s a continuous process throughout the device lifecycle.
European Union (EU – MDR 2017/745)
The EU MDR mandates a robust and ongoing clinical evaluation process for all medical devices, regardless of classification. Manufacturers must provide a comprehensive CER to obtain and maintain CE marking. Notified bodies closely review CERs, especially for Class IIa, IIb, and III devices.
Australia (TGA)
The Therapeutic Goods Administration (TGA) also mandates clinical evidence to support inclusion on the Australian Register of Therapeutic Goods (ARTG). A well-developed CER simplifies TGA submissions, especially under the conformity assessment routes.
Canada (Health Canada)
While not always requiring a separate CER, Health Canada expects clear clinical justification in licensing applications for Class III and IV devices. A strong CER can serve as a foundational component of this documentation.
Other Jurisdictions (e.g., FDA, PMDA)
Why is a CER Important for Manufacturers?
⦿ Demonstrates compliance with regulatory expectations
⦿ Supports CE marking, renewals, and vigilance reporting
⦿ Helps justify the clinical benefit-to-risk ratio
⦿ Reduces the risk of non-conformities and notified body findings
⦿ Aids in post-market clinical follow-up (PMCF) planning
Failing to meet CER expectations can result in delays, rejections, or withdrawals of regulatory approvals. That’s why Elexes offers strategic and technical expertise to build, review, and maintain CERs that meet global standards.
Let Elexes be your clinical evidence partner. From first-time submissions to renewals and remediation, our consultants help you prepare bulletproof CERs with minimal disruptions.
Our End-to-End CER Services
Clinical Evaluation Plan (CEP)
⦿ Define scope, device description, and evaluation strategy
⦿ Develop state-of-the-art and clinical benefit statements
Literature Review & Appraisal
⦿ Systematic search and screening
⦿ Appraisal of clinical literature per MEDDEV 2.7/1 revision 4
⦿ Use of software tools for transparent traceability
Clinical Data Analysis
⦿ Equivalence justification
⦿ Appraisal of post-market clinical data and complaints
⦿ Integration of clinical investigations (if required)
CER Compilation & Gap Closure
⦿ Create a complete, MDR-compliant CER
⦿ Align with MEDDEV 2.7/1 revision 4 compliance, and relevant harmonized standards
⦿ Provide response support for NB questions or audits
Whether you're starting from scratch or updating a legacy CER, we provide strategic, scalable solutions.
Our Services
Our Compliance Assessment Process
Our process begins with an in-depth consultation where we learn about your medical device, its intended use, and your specific goals. This helps us tailor our assessment to your unique needs.
Our team of experts is well-versed in global medical device regulations, including FDA submissions, CE marking, TGA requirement, Health Canada approvals, ISO, and more. We stay up-to-date with the latest changes in the regulatory landscape.
We will conduct a comprehensive review of your existing documentation, including design files, clinical data, quality management systems, and risk assessments.
Our consultants will perform a gap analysis to identify any areas where your device may fall short of compliance. This forms the basis for our recommendations.
Based on our findings, we will provide you with detailed recommendations and a roadmap for achieving compliance. This may involve revising documentation, conducting additional testing, or making necessary design changes.
Our services don't stop with just the assessment. We offer ongoing support to guide you through the compliance process, helping you address any challenges that may arise.
Why Choose Elexes for CER Development?
⦿ Expert Regulatory Insight
We have MDR experts, former notified body reviewers, and PhD-level researchers experienced in CERs for multiple device classes.
⦿ Speed Without Compromise
Our structured approach reduces timelines while ensuring MDR compliance.
⦿ Evidence-Centric Approach
We align with the latest MDCG guidance and provide transparent justification for clinical claims.
⦿ Confidential, Compliant & Client-Focused
We protect your intellectual property and deliver personalized, clear communication every step of the way.
Understanding the Clinical Evaluation Landscape
A quick look at the step-by-step CER process under EU MDR and how global regulatory requirements compare.
Quick Turn around
Experience timely results with our efficient services.
Confidentiality guaranteed
We offer 100% confidentiality understanding how critical the data is for you.
Elexes offer complete range of regulatory and compliance expertise, ensuring full-support in product development and post-market compliance. Get everything under one roof for your medical device!
Our New Product Approval Service Corner
We offer different services that will help you not only keep your product well in boundaries of regulations but also speed up the entire approval process. Some of these services are -
Associated Regulatory Authorities.
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Tom Birney
CEO Masterlink, Arizona
“
Elexes gave us immense support. Their Knowledge and thoroughness were excellent. I look for all of these qualities in consulting firms
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Diane Bryant
CEO Novasignal, Los Angeles
“Prompt and competent! Elexes should be your next regulatory consultant. Their timeline-based project plan expedited the process.
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Daniel Kinsey
President ViDava, Florida
“Professional and easy to work with! They expedited CE Marking for our products and also created clinical evaluations, risk assessments, and provided testing/manufacturing advice.
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Linda Pan
Sr. Exe Treedental, Hong Kong
“Having Elexes as our import-export expert was a great choice. Elexes' team answered all our questions and guided us through every step.
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Joshua Mink
Manager Outset Medical, California
“Highly recommend Elexes! They always meet commitments and follow through on action items.
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Michal Depa
CTO Jana Care, Massachusetts
“Highly recommended! They excelled at regulatory projects, and document control, and grasped our product's nuances quickly.
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Philip McFerran
MD Blackrock Pharma, England
“Kudos to the Elexes team! They're always proactive and have provided invaluable support to us with import, labels, and registrations.
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Samip Shah
VP Regulatory AliveCor, California
“Excellent communication, diligent work. There is a strong quality background and QMS norms expertise.
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Elizabeth W
Owner Liz Inc., Arizona
“Accurate and amazing! Their regulatory-compliant fact sheets for multiple products enabled us to sell domestically and internationally without issues. Their work had an impressive turnaround time.
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Kurt Sysock
CEO Radformation, New York
“Elexes is a go-to for all FDA regulatory and quality systems work. They outperformed every expectation!
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