--- title: "CER, Clinical Evaluation Report | MedTech Terms" description: "Documented assessment of clinical data demonstrating EU MDR conformity for a device. Plain-English Clinical & Trials definition for MedTech teams, with examples" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cer#term", "name": "Clinical Evaluation Report", "alternateName": "CER", "description": "A CER systematically appraises and analyses clinical data to verify clinical safety, performance, and the clinical benefit-risk profile of a device under MDR Annex XIV. 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The data collected through PMCF activities directly feeds into and influences updates to the CER, ensuring it reflects real-world performance and safety." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Clinical & Trials](/terms?cat=Clinical%20%26%20Trials) 6. / 7. Clinical Evaluation Report [All terms](/terms) Clinical & Trials [Regulated Pathways](/ecosystems/regulated-pathways)[Clinical Evidence](/ecosystems/clinical-evidence)[Global Markets](/ecosystems/global-markets)[Startup Lifecycle](/ecosystems/startup-lifecycle)CER # Clinical Evaluation Report Documented assessment of clinical data demonstrating EU MDR conformity for a device. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A CER systematically appraises and analyses clinical data to verify clinical safety, performance, and the clinical benefit-risk profile of a device under [MDR](/terms/mdr-reporting) Annex XIV. It must be updated throughout the device lifecycle. What the regulation says The [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) Annex XIV mandates the Clinical Evaluation Report (CER) as a critical document for demonstrating a device's safety and performance. This report systematically appraises and analyzes clinical data, encompassing data generated during preclinical development, clinical investigations, and [post-market surveillance](/terms/post-market-surveillance). The FDA requires similar documentation for demonstrating reasonable assurance of safety and effectiveness, often through [premarket approval](/terms/pma) (PMA) applications, which include clinical data analysis. ## What this means in practice [MDR](/terms/mdr-reporting) raised the clinical-evidence bar substantially over MDD: equivalence claims to other devices are tightly constrained, and [post-market clinical follow-up](/terms/pmcf) (PMCF) feeds back into the CER. ## Examples - A manufacturer of an orthopedic implant updates its CER with five years of post-market clinical follow-up data, demonstrating sustained long-term safety and performance in a larger patient population. - During a Notified Body audit, a notified body reviewer requests to see the CER for a new diagnostic device and verifies that the clinical data analysis aligns with the device's intended use and claims. - A company developing a novel software as a medical device (SaMD) submits a CER as part of its technical documentation, which includes a systematic review of scientific literature and data from a prospective clinical trial. Common pitfalls - • Failing to include a comprehensive search strategy for relevant clinical data can lead to an incomplete CER. - • Not adequately justifying equivalence claims to a predicate device is a common pitfall. - • Overlooking the continuous update requirement of the CER throughout the device lifecycle often results in non-compliance. - • Poorly documented or insufficient PMCF data can weaken the conclusions of the CER. - • Presenting a CER as a static document, rather than one that evolves with new clinical data, is a frequent mistake. ## Frequently asked questions What is the primary purpose of a Clinical Evaluation Report? The primary purpose of a CER is to demonstrate that a medical device achieves its intended performance without compromising the safety or health of patients, users, or other persons, as required by EU [MDR](/terms/mdr-reporting) Annex XIV. How often must a CER be updated? What is the relationship between a CER and PMCF? ## Cross-references ### Part of A larger framework or document this term belongs to. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ### Precedes Comes before in a typical workflow or lifecycle. - [ Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr)[ Post-Market Post-Market Clinical Follow-up(PMCF) Proactive collection of clinical data on a CE-marked device to confirm safety and performance. ](/terms/pmcf) ### Clinical Trials & Evidence · From this learning path [ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. Adjacent lesson ](/terms/real-world-evidence?from=clinical-trials-and-evidence)[ Clinical & Trials Risk-Based Monitoring(RBM) Monitoring strategy that targets oversight resources to the highest-risk sites, processes, and data based on a documented risk assessment, replacing 100% source data verification. Adjacent lesson ](/terms/risk-based-monitoring?from=clinical-trials-and-evidence)[ Clinical & Trials Adaptive Trial Design Trial design that pre-specifies opportunities to modify aspects (sample size, arms, endpoints) based on interim data. ](/terms/adaptive-trial?from=clinical-trials-and-evidence)[ Clinical & Trials Adverse Event(AE) Any untoward medical occurrence in a subject, whether or not related to the device. ](/terms/adverse-event?from=clinical-trials-and-evidence) ### More in Clinical & Trials · Same category [ Clinical & Trials Feasibility Study Small clinical study evaluating initial safety, usability, and design parameters of an investigational device. ](/terms/feasibility-study) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [Clinical Trials & Evidence](/paths/clinical-trials-and-evidence)Lesson 17 of 18 Ecosystems (4) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Clinical Evidence](/ecosystems/clinical-evidence) - [Global Markets](/ecosystems/global-markets) - [Startup Lifecycle](/ecosystems/startup-lifecycle) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 NIH· 1 ICH· 1 ISO· 1 1. [1 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) 2. [2 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 3. [3 ISO 14155 Standard Page Verified ISO · iso.org ](https://www.iso.org/standard/71690.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Clinical evidence intersecting with device security? We support clinical-stage MedTech teams whose investigational devices touch patient data or hospital networks. [Book a 30-minute discovery session](https://go.bluegoatcyber.com/meetings/blue-goat-cyber/discovery-session) - No obligation - Expert-led from minute one - NDA available on request MedTech Terms is a community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com). Definitions are independent of any vendor. On this term Category Clinical & Trials Acronym CER Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=cer) Learn in 60 seconds Card Lesson Quiz Documented assessment of clinical data demonstrating EU MDR conformity for a device. - · MDR raised the clinical-evidence bar substantially over MDD: equivalence claims to other devices are tightly constrained, and post-market clinical follow-up (PMCF) feeds back into the CER. - · It must be updated throughout the device lifecycle. Remember this Watch out: Failing to include a comprehensive search strategy for relevant clinical data can lead to an incomplete CER. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [ISO 14155 ](/terms/iso-14155) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Clinical Evaluation Plan(CEP) ](/terms/clinical-evaluation-plan) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [CE Mark ](/terms/ce-mark) - [General Safety and Performance Requirements(GSPRs) ](/terms/gspr) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) [All Clinical & Trials terms](/terms?cat=Clinical%20%26%20Trials) From the Blue Goat network Related resources and services on this topic. - [ MedTech Launchpad MedTech funding rounds, accelerators, and launch resources. ](https://medtechlaunchguide.com) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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