Our Clinical Evaluation services support medical device manufacturers in developing compliant Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER) in line with EU MDR requirements. Patient Guard provides expert guidance to ensure your clinical evidence demonstrates safety, performance, and regulatory compliance.
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.
Since 2017, we specialise deep within medical device clinical and regulatory compliance frameworks to ensure secure market access.
We actively support technical medical device manufacturers across all product classes, complexities, and evolving technologies.
We completely align your entire clinical evaluation process with strict EU MDR, MEDDEV, and global Notified Body expectations.
Our team ensures highly robust, scientifically defensible clinical literature data to easily withstand aggressive regulatory audits.
We provide full structural support, driving from the initial planning stages straight through to comprehensive CER development.
We work with fully transparent, project-based pricing structures to ensure absolute clarity with no hidden ongoing costs.
We develop fully compliant Clinical Evaluation Plans that outline clear technical scopes, evaluation methodologies, and specific data requirements.
Our experts perform systematic literature searches and critically appraise relevant clinical data to verify scientific credibility.
We deeply analyse clinical evidence parameters to safely demonstrate product safety, performance, and clear benefit-risk metrics.
We prepare thoroughly comprehensive CER files aligned with current EU MDR expectations and standard MEDDEV 2.7/1 Rev. 4 guidelines.
We formulate and support robust, compliant equivalence strategies to justify clinical data pathways where technically applicable.
Our team perfectly aligns your clinical data evaluations alongside core ISO 14971 risk management processes for complete technical consistency.
We maintain absolute structural consistency across your post-market pathways, locking evaluations with continuous follow-up activities.
We deliver continuous monitoring and data updates to keep your technical evaluation files compliant throughout the full lifecycle.
Under EU MDR Annex XIV, manufacturers must:
A robust Clinical Evaluation is essential for CE marking and ongoing regulatory compliance.
We assess your device, intended use, and existing data to develop a compliant Clinical Evaluation Plan
We conduct literature searches, appraise clinical data, and analyse evidence
We prepare the Clinical Evaluation Report and align outputs with PMCF, PMS, and risk management
We support Clinical Evaluation services across:
From
Ensure regulatory compliance and market readiness with expertly prepared Performance Evaluation Plans and Reports. Combined Plan and Report Pricing starts from £9,000, with preferential rates for multiple products.
Assess device, intended use, and existing data, then develop a compliant Clinical Evaluation Plan (CEP)
Conduct systematic literature searches, appraise clinical data, and perform gap analysis
Prepare the Clinical Evaluation Report (CER) and align outputs with PMCF, PMS, and risk management
Clinical Evaluation is the process of assessing clinical data to demonstrate that a medical device is safe and performs as intended.
The CEP defines the clinical evaluation strategy, while the CER presents the analysis and conclusions of clinical data.
Yes, Clinical Evaluation is a mandatory requirement for CE marking under EU MDR.
CERs should be updated regularly based on device classification and PMS/PMCF data.
Yes, we perform systematic literature searches and critical appraisals in line with regulatory expectations.
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Speak to one of our regulatory and compliance experts to arrange an obligation-free call. Our experienced team is ready to help you get your medical device to market.
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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For help with the checklist or other aspects of your compliance journey, please reach out to us at Patient Guard and our experts would be happy to help.
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