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.
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:
Our consultants help identify appropriate clinical data sources, establish equivalence where applicable, and prepare compliant Clinical Evaluation Reports suitable for regulatory review.
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:
We have experience supporting manufacturers of infusion devices, administration sets, surgical instruments, diagnostic devices, software products and a wide range of other regulated technologies.
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:
Our consultants can help identify evidence deficiencies early in the development process to minimise delays during conformity assessment.
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:
We assist in identifying appropriate clinical evidence sources, evaluating performance data and developing compliant Clinical Evaluation Reports that align with MDR and MDCG expectations.
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
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.
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.
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.
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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