Clinical Evaluation Services
Clinical Evaluation is a core requirement under EU MDR (EU 2017/745) and is essential for demonstrating that a medical device is safe, performs as intended, and has an acceptable benefit-risk profile.
Manufacturers must establish and maintain a Clinical Evaluation Plan (CEP) and Clinical Evaluation Report (CER), supported by sufficient clinical data throughout the product lifecycle.
Clinical Evaluation is closely linked to risk management, post-market surveillance, and regulatory submissions such as CE marking.
Patient Guard acts as your clinical evaluation consultancy partner, supporting the development, review, and maintenance of CEPs and CERs aligned with EU MDR, MEDDEV 2.7/1 Rev. 4 and MDCG guidance expectations.
Without a robust Clinical Evaluation, manufacturers risk Notified Body non-conformities, delayed CE marking, and regulatory rejection.
Patient Guard provides expert Clinical Evaluation services tailored to your device classification, intended use, and clinical strategy, ensuring compliance and audit readiness.
Why Choose Patient Guard for Clinical Evaluation?
What Our Clinical Evaluation Service Includes
Who Requires Clinical Evaluation?
Clinical Evaluation for Class I Medical Devices
Manufacturers of Class I medical devices are still required to demonstrate conformity with the General Safety and Performance Requirements (GSPRs) of EU MDR 2017/745. While clinical evaluation requirements are often less extensive than for higher-risk devices, a documented Clinical Evaluation Report (CER) remains a mandatory component of the technical documentation.
Patient Guard supports manufacturers of Class I devices including:
- Non-invasive medical devices
- Reusable surgical instruments
- Medical furniture and accessories
- Basic wound care products
Our consultants help identify appropriate clinical data sources, establish equivalence where applicable, and prepare compliant Clinical Evaluation Reports suitable for regulatory review.
Clinical Evaluation for Class IIa and IIb Medical Devices
Class IIa and IIb medical devices are subject to increased scrutiny under the EU MDR and UK MDR frameworks. Manufacturers must provide robust clinical evidence demonstrating safety, performance and clinical benefits throughout the device lifecycle.
Our Clinical Evaluation services for Class IIa and IIb devices include:
- Clinical Evaluation Plans (CEP)
- Systematic literature reviews
- State-of-the-art analysis
- Clinical data appraisal
- Benefit-risk assessment
- Post-Market Clinical Follow-Up (PMCF) integration
We have experience supporting manufacturers of infusion devices, administration sets, surgical instruments, diagnostic devices, software products and a wide range of other regulated technologies.
Clinical Evaluation for Class III Medical Devices
Class III medical devices require the highest level of clinical evidence. Manufacturers must demonstrate that clinical data adequately supports the intended purpose, safety profile and performance claims of the device.
Patient Guard assists manufacturers with:
- Comprehensive clinical evaluation strategies
- Clinical evidence gap assessments
- PMCF planning
- Clinical Investigation support
- MDR Annex XIV compliance
- Notified Body submission preparation
Our consultants can help identify evidence deficiencies early in the development process to minimise delays during conformity assessment.
Clinical Evaluation for Medical Device Software (SaMD)
Software as a Medical Device (SaMD) presents unique challenges when preparing Clinical Evaluation Reports. Clinical evidence must demonstrate that software outputs are accurate, clinically meaningful and support the intended medical purpose.
Our team supports manufacturers of:
- Diagnostic software
- AI-enabled medical devices
- Clinical decision support systems
- Monitoring applications
- Digital health platforms
We assist in identifying appropriate clinical evidence sources, evaluating performance data and developing compliant Clinical Evaluation Reports that align with MDR and MDCG expectations.
EU MDR Clinical Evaluation Requirements
Under EU MDR Annex XIV, manufacturers must:
A robust Clinical Evaluation is essential for CE marking and ongoing regulatory compliance.
Our Process
Step 1 – Clinical Strategy & Planning
We assess your device, intended use, and existing data to develop a compliant Clinical Evaluation Plan
Step 2 – Data Collection & Analysis
We conduct literature searches, appraise clinical data, and analyse evidence
Step 3 – CER Development & Compliance
We prepare the Clinical Evaluation Report and align outputs with PMCF, PMS, and risk management
Cost of Service
Time Lines
Weeks 1–3 – Clinical Strategy & CEP Development
Assess device, intended use, and existing data, then develop a compliant Clinical Evaluation Plan (CEP)
Weeks 4–8 – Literature Review & Data Analysis
Conduct systematic literature searches, appraise clinical data, and perform gap analysis
Weeks 9–12 – CER Development & Compliance
Prepare the Clinical Evaluation Report (CER) and align outputs with PMCF, PMS, and risk management
Clinical Evaluation Project Examples
Class IIa Infusion Therapy Device
Challenge:
A manufacturer required a Clinical Evaluation Report for a Class IIa infusion therapy device intended for CE marking under EU MDR.
Solution:
Patient Guard developed a Clinical Evaluation Plan, performed systematic literature searches, assessed clinical data and prepared a complete Clinical Evaluation Report aligned with MDR Annex XIV and MEDDEV 2.7/1 Rev. 4.
Outcome:
The manufacturer successfully incorporated the CER into their technical documentation package for regulatory submission.
Software as a Medical Device (SaMD)
Challenge:
A digital health company required clinical evidence to support a software-based diagnostic platform.
Solution:
Our consultants evaluated published clinical literature, assessed performance data and developed a CER demonstrating safety, performance and clinical benefit.
Outcome:
The manufacturer established a clear clinical evidence strategy supporting their conformity assessment activities.
Class III Implantable Device
Challenge:
A manufacturer needed support evaluating available clinical evidence and identifying gaps for a Class III implantable medical device.
Solution:
Patient Guard conducted a clinical evidence gap analysis, developed a PMCF strategy and prepared a Clinical Evaluation Report addressing MDR requirements.
Outcome:
The client obtained a structured clinical evidence roadmap supporting future regulatory submissions.
Note: Project examples are representative of the types of clinical evaluation support provided by Patient Guard.
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