Clinical Evaluation Reports (CERs) and Literature Reviews

Overview

Clinical evaluation is the cornerstone of medical device regulatory compliance, particularly under the European Union Medical Device Regulation (EU MDR). A Clinical Evaluation Report (CER) is a mandatory component of the technical documentation for every medical device requiring CE marking, and it serves as the primary evidence demonstrating that your device is safe, performs as intended, and delivers clinical benefit.

At Veritas Quality Solutions, we provide comprehensive clinical evaluation and literature review services that follow rigorous regulatory guidelines, including MEDDEV 2.7/1 Rev. 4, EU MDR 2017/745 Annex XIV, and MDCG guidance documents. Our team combines clinical expertise with regulatory knowledge to develop robust, defensible clinical evaluation documentation that withstands Notified Body scrutiny.

What is Clinical Evaluation?

Clinical evaluation is a systematic and planned process to continuously generate, collect, analyse, and assess the clinical data pertaining to a device. Its purpose is to verify the safety and performance, including clinical benefits, of the device when used as intended by the manufacturer.

Under EU MDR, clinical evaluation is not a one-time exercise but a continuous activity throughout the device lifecycle. It must be:

Systematic: Following a defined, reproducible methodology

Transparent: Documented clearly enough for independent verification

Evidence-Based: Grounded in scientifically valid clinical data

Current: Updated regularly based on new data and post-market information

The Clinical Evaluation Report (CER)

The Clinical Evaluation Report is the document that captures and presents the entire clinical evaluation process. It is not a summary but a complete record that your Notified Body will review during conformity assessment. Every substantive claim must be cross-referenced to supporting documentation, and the report must clearly distinguish between statements substantiated by clinical data and evaluator conclusions or judgment.

Key Components of a CER

Based on MEDDEV 2.7/1 Rev. 4 and EU MDR requirements, a compliant CER includes:

Our Clinical Evaluation Services

1. Clinical Evaluation Plan Development

We develop or review your Clinical Evaluation Plan (CEP), which defines the scope and methodology for the clinical evaluation. The CEP is a critical prerequisite that must be established before the literature search begins.

What We Do:

Define the scope and objectives of the clinical evaluation

Establish the research questions using the PICO framework (Population, Intervention, Comparator, Outcome)

Define the literature search protocol, including databases, search strings, and inclusion/exclusion criteria

Establish appraisal criteria for assessing data quality and relevance

Define the equivalence approach, if applicable

Document the analysis plan for data synthesis

2. Systematic Literature Review

A robust Systematic Literature Review (SLR) is the backbone of every credible CER. It provides the objective clinical evidence needed to substantiate regulatory claims, and it is one of the sections Notified Bodies scrutinize most carefully.

Our Literature Review Process:

Step 1: Defining the Objective and Scope

Every SLR begins with a clearly defined research question aligned with the device's intended purpose, indications, and clinical claims. We use the PICO framework to structure the objective, ensuring focus and relevance.

Step 2: Designing a Robust Search Strategy

An effective search strategy combines scientific precision with regulatory awareness. We conduct comprehensive searches covering:

PubMed: For biomedical literature

Embase: European database with broader coverage of medical devices

Cochrane Library: Systematic reviews and meta-analyses

Scopus: Multidisciplinary scientific literature

All decisions, including database selection, time filters, and search terms, are documented to ensure transparency and reproducibility.

Step 3: Screening and Study Selection

Screening involves a two-level process: title and abstract review, followed by full-text assessment. To minimise bias, two independent reviewers typically conduct screening based on predefined criteria. We use PRISMA flow diagrams to visualize the search and selection process.

Step 4: Data Extraction and Quality Appraisal

Eligible studies are analysed using standardised templates capturing study design, population, intervention, outcomes, and comparators. Each study is critically appraised using validated frameworks:

Step 5: Data Synthesis and Analysis

Extracted studies are synthesised to establish clinical safety, performance, and the State of the Art. Comparative analyses help demonstrate equivalence, highlight clinical benefits, and inform benefit-risk evaluations.

3. Clinical Evaluation Report Preparation

We prepare comprehensive CERs that meet the transparency standard required by MEDDEV 2.7/1 Rev. 4. Every substantive claim is cross-referenced to supporting documentation, and the report provides enough detail for external parties, including Notified Body reviewers, to understand the search criteria, data available, assumptions made, and conclusions reached.

4. Equivalence Assessment

Where equivalence to a predicate device is claimed, we conduct rigorous equivalence assessments covering clinical, technical, and biological characteristics. Under MEDDEV 2.7/1 Rev. 4, equivalence must be demonstrated comprehensively, and all equivalent devices must be CE-marked.

What We Do:

Identify and characterize equivalent devices

Prepare comparative tables covering technical, biological, and clinical characteristics

Identify and justify any differences and explain why they do not affect clinical performance and safety

For implantable and Class III devices, ensure evidence of access to technical documentation is in place

5. State of the Art Assessment

Under EU MDR, manufacturers must demonstrate not just that the device performs safely, but that the benefit-risk profile is acceptable relative to the current standard of medical practice. We conduct comprehensive State of the Art (SOTA) assessments covering:

Current clinical guidelines from recognized professional societies

Alternative treatments and devices available

Benchmark devices and medical alternatives

Clinical outcomes and accepted performance metrics

6. Post-Market Clinical Follow-Up (PMCF) Integration

Clinical evaluation is a continuous process. We help you integrate PMCF data into your CER and establish a framework for ongoing clinical evidence generation.

What We Do:

Develop PMCF plans that satisfy MDR requirements

Integrate PMCF data into CER updates

Establish CER update schedules based on device risk class

Ensure alignment between PMS, PMCF, and CER documentation

CER Update Requirements Under EU MDR

One of the concrete changes EU MDR introduced is the formalization of the CER update schedule across device risk classes:

The update obligation is not a formality. Notified Bodies check that the clinical evidence base has been reviewed against recent literature and post-market data. A CER with a literature search cutoff more than one or two years old, without documented justification, is a common nonconformity finding.

Common Deficiencies We Help You Avoid

Based on our experience and regulatory guidance, the most common CER deficiencies identified during Notified Body reviews include:

Incomplete Search Strategies: Searches that rely on a limited number of databases, use insufficient search terminology, or lack clear justification for the methodology

Poor Documentation and Traceability: Missing search histories, undocumented screening decisions, or incomplete evidence tracking

Inconsistent Evidence Appraisal: Subjective or poorly documented critical appraisal criteria

Outdated Evidence: Reviews that are not regularly updated to reflect new publications

Inadequate Equivalence Justification: Failure to comprehensively address all equivalence criteria or insufficient access to technical documentation

Weak State of the Art Analysis: Insufficient comparison against current clinical practice and alternatives

We structure our clinical evaluation services specifically to address these deficiencies and deliver documentation that withstands regulatory scrutiny.

Why Choose Veritas Quality Solutions

Regulatory Expertise

Our team has extensive experience with EU MDR requirements, MEDDEV 2.7/1 Rev. 4 guidelines, and MDCG guidance documents. We understand what Notified Bodies look for and how to present clinical evidence effectively.

Clinical Rigour

We follow international standards of evidence-based medicine, using validated appraisal frameworks and systematic methodologies that ensure your clinical evaluation is scientifically defensible.

Comprehensive Support

From CEP development through to PMCF integration, we support the entire clinical evaluation lifecycle. Whether you need a full CER or specific components, we tailor our services to your needs.

Proven Track Record

We have supported manufacturers across device classes and therapeutic areas, helping them achieve CE certification and maintain compliance under EU MDR.

Practical Approach

We do not just produce documents. We work with your team to ensure that clinical evaluation is integrated into your quality management system and that your clinical evidence strategy supports your regulatory and commercial objectives.

Get Started

Whether you are preparing a first CER, updating an existing CER under EU MDR, or seeking support for a specific clinical evaluation component, Veritas Quality Solutions is here to help.

Veritas Quality Solutions, Your Partner in Quality Assurance