Clinical Evaluation For Medical Devices

Clinical Evaluation Reports For Medical Devices, Done Right

EU MDR 2017/745 compliant Clinical Evaluation Reports developed by experienced regulatory and clinical writers. We deliver comprehensive Clinical Data Evaluation, Systematic Literature Review activities, and structured benefit-risk analyses designed to support notified body review and demonstrate ongoing EU MDR compliance.
A well-prepared Clinical Evaluation Report (CER) is a critical component of regulatory submissions and ongoing compliance for medical devices. Our team combines regulatory expertise with scientific and clinical knowledge to develop clear, evidence-based evaluations that support product safety, performance, and regulatory acceptance.
Whether you require a new Clinical Evaluation Report (CER), updates to existing documentation, or strategic Clinical Evaluation Consulting, MDRA provides practical support tailored to your device and regulatory pathway.

What We Do: Comprehensive Clinical Evaluation
Report (CER) Support

MDRA offers specialised Clinical Evaluation Services across the entire CER lifecycle, from clinical evidence strategy and literature evaluation to benefit-risk analysis and notified body submission support.
Our services are aligned with EU MDR requirements and applicable guidance to support robust, defensible clinical evaluations for medical devices and IVDs.

Our Clinical Evaluation Support includes:

• Clinical Evaluation Plan (CEP) development and maintenance.
• Clinical Evaluation Report (CER) preparation and updates.
• Systematic Literature Review and literature appraisal.
• Clinical Evidence Evaluation and gap analysis.
• Clinical Data Evaluation and scientific assessment.
• Benefit-risk analysis and clinical justification.
• Post-market clinical evidence review.
• Notified body submission support.
• EU MDR Clinical Evaluation strategy and documentation.

Clinical Evaluation Plan (CEP)

A Clinical Evaluation Plan establishes the methodology and framework for the clinical evaluation process.
Our team develops a structured Clinical Evaluation Plan (CEP) that defines the scope, objectives, data sources, appraisal methods, and evaluation criteria required to support regulatory expectations. A well-prepared Clinical Evaluation Plan helps create a clear and consistent approach throughout the evaluation process.
support

Clinical Evaluation Report (CER)

The Clinical Evaluation Report (CER) brings together clinical evidence, literature findings, post-market information, and benefit-risk conclusions into a comprehensive regulatory document.
Our regulatory and clinical specialists prepare CER Medical Device documentation that is scientifically robust, well-structured, and aligned with current regulatory expectations. We focus on creating defensible reports that support regulatory submissions while maintaining clarity and traceability throughout the evaluation.

Clinical Evidence Evaluation and Literature Reviews

High-quality clinical evidence is fundamental to demonstrating device safety and performance.
MDRA conducts detailed Clinical Evidence Evaluation activities, including Systematic Literature Review processes designed to identify, assess, and analyse relevant clinical data. Our structured approach helps ensure evidence is reviewed consistently and documented in accordance with applicable guidance and regulatory requirements.
By combining published literature, clinical experience, post-market information, and device-specific data, we support a comprehensive evaluation of the available evidence.

Supporting EU MDR Compliance

Clinical evaluation remains a central requirement under the European Medical Device Regulation.
Our Clinical Evaluation Consulting services help manufacturers understand and address the clinical evidence requirements associated with EU MDR compliance. Whether supporting a new product, updating legacy documentation, or responding to notified body feedback, we provide practical guidance throughout the process.
We support manufacturers across Canada, Australia, the UK, UAE, Europe, and other international markets, helping ensure clinical evaluation activities align with broader regulatory and market access strategies.

How we work: Our Proven 5-Step CER Workflow

Our structured process helps ensure consistency, transparency, and regulatory alignment throughout the clinical evaluation lifecycle.

1

1. Clinical evaluation strategy and planning.

2

2. Clinical evidence identification and collection.

3

3. Literature screening and appraisal.

4

4. Clinical data analysis and benefit-risk assessment.

5

5. CER preparation, review, and regulatory support.

This approach helps create a clear, evidence-based pathway from initial planning through to final report delivery.

Are You Ready for a Clinical Evaluation Report?

Whether you need support developing a Clinical Evaluation Plan, updating an existing Clinical Evaluation Report, conducting a Systematic Literature Review, or strengthening your EU MDR Clinical Evaluation strategy, MDRA can help.
Speak with our team to discuss your device, regulatory objectives, and clinical evidence requirements.