Clinical Evaluation Report (CER) Services

Cert3Global provides structured Clinical Evaluation Report (CER) services to support medical device manufacturers in preparing documentation aligned with EU MDR (2017/745) requirements. Clinical evaluation is a critical component of regulatory compliance, used to demonstrate that a medical device achieves its intended purpose while maintaining an acceptable safety and performance profile.

Our services focus on supporting the preparation, review, and ongoing maintenance of CER documentation using a systematic and evidence-based approach. We assist manufacturers in aligning their clinical evaluation processes with MDR expectations and applicable guidance documents.

Understanding Clinical Evaluation Under MDR

Clinical evaluation is a continuous process required under MDR, where manufacturers must assess clinical data to confirm the safety and performance of a device. This process involves collecting, analysing, and evaluating relevant clinical information throughout the product lifecycle.

A Clinical Evaluation Report (CER) documents this process and forms an essential part of the technical documentation submitted for conformity assessment. It is used by notified bodies and regulatory authorities to assess whether a device meets regulatory requirements.

The CER must be based on sufficient clinical evidence, which may include scientific literature, clinical investigations, post-market data, and real-world evidence.

Key GPSR Requirements

The GPSR introduces several important compliance requirements that businesses must address.

Clinical Data Identification & Evaluation

We support the identification and assessment of relevant clinical data sources, including published literature, clinical studies, and post-market information. This process involves evaluating the quality, relevance, and reliability of available data.

Scientific Literature Review

A systematic literature review is conducted to identify clinical evidence related to the device or equivalent devices. We support structured search strategies, screening criteria, and documentation of findings to ensure traceability and reproducibility.

Equivalence Assessment (Where Applicable)

For devices claiming equivalence, we assist in evaluating technical, biological, and clinical characteristics in line with MDR requirements. This includes assessing whether sufficient access to equivalent device data is available to support the claim.

Clinical Data Analysis & Appraisal

We support the critical appraisal of clinical data to assess safety, performance, and potential risks. This includes evaluating study quality, identifying data gaps, and determining the strength of available evidence.

Risk-Benefit Analysis

Clinical evaluation requires a clear assessment of whether the benefits of a device outweigh its risks. We support the development of structured risk-benefit analysis aligned with risk management documentation.

CER Writing & Documentation

We assist in preparing complete Clinical Evaluation Reports that align with MDR and MEDDEV 2.7/1 Rev. 4 guidance. This includes structuring the report, presenting evidence clearly, and ensuring consistency with the overall technical file.

Gap Analysis & Remediation Support

We identify gaps in clinical evidence or documentation and provide recommendations for addressing them. This may include additional data collection, literature updates, or process improvements.

CER Updates & Lifecycle Maintenance

Under MDR, clinical evaluation is an ongoing requirement. We support periodic CER updates, ensuring that documentation remains current and aligned with post-market data and regulatory expectations.

Clinical Evaluation Process (Overview)

The clinical evaluation process follows a structured methodology:

Define device scope and intended use
Identify applicable regulatory requirements
Collect and review clinical data
Conduct literature review and screening
Analyse and appraise clinical evidence
Perform risk-benefit assessment
Prepare the Clinical Evaluation Report
Review and update documentation periodically

Each stage requires careful documentation and alignment with regulatory guidance.

Who Needs Clinical Evaluation Report Services?

CER services are required for:

Medical device manufacturers seeking CE marking
Companies transitioning from MDD to MDR
Manufacturers undergoing notified body review
Businesses launching new devices
Companies updating clinical documentation

The level of clinical evidence required depends on device classification and risk level.

Why Clinical Evaluation is Important

Clinical evaluation plays a central role in demonstrating compliance with MDR. Without adequate clinical evidence, manufacturers may face:

A structured approach to clinical evaluation helps:

Why Choose Cert3Global?

Cert3Global provides structured, evidence-based support for clinical evaluation and CER preparation.

We provide:

Our approach focuses on clarity, consistency, and regulatory alignment.

Start Your Clinical Evaluation Process

Clinical evaluation is a critical component of regulatory compliance for medical devices. A well-prepared CER supports conformity assessment and helps demonstrate safety and performance.

Cert3Global supports manufacturers throughout the process—from initial evaluation to ongoing updates.

FAQs

What is a Clinical Evaluation Report (CER)?

A CER is a document that evaluates clinical data to demonstrate the safety and performance of a medical device.

Is a CER mandatory under MDR?

Yes, all medical devices require clinical evaluation under MDR.

What data is used in a CER?

Clinical data may include published literature, clinical studies, and post-market information.

How often should a CER be updated?

CERs must be updated periodically based on device risk class and available post-market data.

Disclaimer

Cert3Global provides regulatory consulting and documentation support services. Regulatory outcomes and conformity assessments remain subject to applicable MDR requirements and notified body decisions.