--- title: "CEP, Clinical Evaluation Plan | MedTech Terms" description: "EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report…" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/clinical-evaluation-plan#term", "name": "Clinical Evaluation Plan", "alternateName": "CEP", "description": "A Clinical Evaluation Plan (CEP) is a structured planning document required under EU MDR (Annex XIV Part A §1(a)) that defines how the manufacturer will conduct the clinical evaluation of a medical device. The CEP identifies the device and its intended purpose, the equivalence claim (if any), the clinical development stages, the data sources to be evaluated (clinical investigations, literature, post-market data), the acceptance criteria for clinical performance and safety, the benefit-risk methodology, and the plan for ongoing clinical evaluation through PMCF. The CER documents the execution of the CEP.", "url": "https://medtechterms.com/terms/clinical-evaluation-plan", "termCode": "clinical-evaluation-plan", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/clinical-evaluation-plan#article", "headline": "CEP, Clinical Evaluation Plan", "description": "EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER).", "url": "https://medtechterms.com/terms/clinical-evaluation-plan", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/clinical-evaluation-plan" }, "about": { "@id": "https://medtechterms.com/terms/clinical-evaluation-plan#term" }, "articleSection": "Clinical & Trials", "inLanguage": "en", "keywords": "Clinical Evaluation Plan, CEP, Clinical & Trials, medical device, MedTech", "author": { "@type": "Person", "name": "Christian Espinosa", "jobTitle": "Founder, Blue Goat Cyber", "url": "https://bluegoatcyber.com" }, "publisher": { "@type": "Organization", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "isPartOf": { "@type": "WebSite", "name": "MedTech Terms", "url": "https://medtechterms.com" }, "datePublished": "2026-06-20", "dateModified": "2026-06-20", "citation": [ { "@type": "CreativeWork", "name": "EU MDR Annex XIV", "url": "https://eur-lex.europa.eu/eli/reg/2017/745/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "ClinicalTrials.gov", "url": "https://clinicaltrials.gov/", "publisher": { "@type": "Organization", "name": "NIH" } }, { "@type": "CreativeWork", "name": "ICH Guidelines", "url": "https://www.ich.org/page/ich-guidelines", "publisher": { "@type": "Organization", "name": "ICH" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/cer#term", "name": "Clinical Evaluation Report", "alternateName": "CER", "url": "https://medtechterms.com/terms/cer" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmcf#term", "name": "Post-Market Clinical Follow-up", "alternateName": "PMCF", "url": "https://medtechterms.com/terms/pmcf" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/pmpf#term", "name": "Post-Market Performance Follow-up", "alternateName": "PMPF", "url": "https://medtechterms.com/terms/pmpf" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr-article-117#term", "name": "MDR Article 117", "url": "https://medtechterms.com/terms/mdr-article-117" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdcg#term", "name": "Medical Device Coordination Group Guidance", "alternateName": "MDCG", "url": "https://medtechterms.com/terms/mdcg" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/iso-14155#term", "name": "ISO 14155", "url": "https://medtechterms.com/terms/iso-14155" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/real-world-evidence#term", "name": "Real-World Evidence", "alternateName": "RWE", "url": "https://medtechterms.com/terms/real-world-evidence" } ] }, { "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": 1, "name": "Home", "item": "https://medtechterms.com/" }, { "@type": "ListItem", "position": 2, "name": "Terms", "item": "https://medtechterms.com/terms" }, { "@type": "ListItem", "position": 3, "name": "Clinical & Trials", "item": "https://medtechterms.com/terms?cat=Clinical%20%26%20Trials" }, { "@type": "ListItem", "position": 4, "name": "Clinical Evaluation Plan", "item": "https://medtechterms.com/terms/clinical-evaluation-plan" } ] } ] } --- [ 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 Plan [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)CEP # Clinical Evaluation Plan EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed June 20, 2026 ## Definition A Clinical Evaluation Plan (CEP) is a structured planning document required under EU [MDR](/terms/mdr-reporting) (Annex XIV Part A §1(a)) that defines how the manufacturer will conduct the clinical evaluation of a medical device. The CEP identifies the device and its intended purpose, the equivalence claim (if any), the clinical development stages, the data sources to be evaluated (clinical investigations, literature, post-market data), the acceptance criteria for clinical performance and safety, the benefit-risk methodology, and the plan for ongoing clinical evaluation through [PMCF](/terms/pmcf). The [CER](/terms/cer) documents the execution of the CEP. What the regulation says EU [MDR](/terms/mdr-reporting) Annex XIV Part A §1(a) requires a CEP. [MDCG](/terms/mdcg) 2020-13 (Clinical evaluation assessment report template) is what Notified Bodies use to evaluate the [CER](/terms/cer) against the CEP. For legacy devices, MDCG 2020-6 provides guidance on clinical evidence for legacy devices. ## What this means in practice Under [MDR](/terms/mdr-reporting), the CEP is the upfront commitment that disciplines the entire clinical evaluation process, Notified Bodies review the CEP for adequacy before accepting a [CER](/terms/cer). A weak or generic CEP is one of the most common causes of MDR clinical evaluation deficiencies. [MDCG](/terms/mdcg) 2020-13 provides the CER assessment template that Notified Bodies use, and it is essentially scoring CER conformance against the CEP. Common pitfalls - • Writing a generic CEP that doesn't actually scope the clinical evaluation, Notified Bodies will issue major deficiencies. - • Skipping the equivalence rationale in the CEP and then claiming equivalence in the CER, must be planned upfront. - • Failing to align the CEP with the PMCF plan, they are intended to form a continuous evidence loop. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Post-Market Post-Market Performance Follow-up(PMPF) The IVDR counterpart of PMCF: ongoing collection and analysis of performance data after CE certification. ](/terms/pmpf)[ Clinical & Trials Clinical Evaluation Report(CER) Documented assessment of clinical data demonstrating EU MDR conformity for a device. ](/terms/cer)[ Clinical & Trials Real-World Evidence(RWE) Clinical evidence regarding the usage and potential benefits or risks of a device derived from real-world data. ](/terms/real-world-evidence)[ Standards ISO 14155 Good clinical practice for clinical investigations of medical devices. ](/terms/iso-14155) ### IVDR Essentials · From this learning path [ Regulatory General Safety and Performance Requirements(GSPRs) Annex I requirements under EU MDR/IVDR that every device must demonstrate it meets. Adjacent lesson ](/terms/gspr?from=ivdr-essentials)[ Regulatory CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark?from=ivdr-essentials)[ Market Segments Companion Diagnostic(CDx) IVD that identifies patients who will benefit from a specific drug. ](/terms/companion-diagnostic?from=ivdr-essentials)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr?from=ivdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [IVDR Essentials](/paths/ivdr-essentials)Lesson 7 of 13 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 EUR-Lex· 1 NIH· 1 ICH· 1 1. [1 EU MDR Annex XIV Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 ClinicalTrials.gov Verified NIH · clinicaltrials.gov ](https://clinicaltrials.gov/) 3. [3 ICH Guidelines Verified ICH · ich.org ](https://www.ich.org/page/ich-guidelines) 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 CEP Sources 3 Updated 6/20/2026 [Compare with another term](/compare?a=clinical-evaluation-plan) Learn in 60 seconds Card Lesson Quiz EU MDR document that defines the scope, methods, and acceptance criteria for the clinical evaluation that will be reported in the Clinical Evaluation Report (CER). - · Under MDR, the CEP is the upfront commitment that disciplines the entire clinical evaluation process, Notified Bodies review the CEP for adequacy before accepting a CER. - · A weak or generic CEP is one of the most common causes of MDR clinical evaluation deficiencies. - · MDCG 2020-13 provides the CER assessment template that Notified Bodies use, and it is essentially scoring CER conformance against the CEP. Remember this Watch out: Writing a generic CEP that doesn't actually scope the clinical evaluation, Notified Bodies will issue major deficiencies. Related terms - [Clinical Evaluation Report(CER) ](/terms/cer) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [Post-Market Performance Follow-up(PMPF) ](/terms/pmpf) - [MDR Article 117 ](/terms/mdr-article-117) - [Medical Device Coordination Group Guidance(MDCG) ](/terms/mdcg) - [ISO 14155 ](/terms/iso-14155) - [Real-World Evidence(RWE) ](/terms/real-world-evidence) You may also need Auto-suggested from Clinical & Trials and shared keywords. - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [Post-Market Performance Follow-Up (IVDR)(PMPF) ](/terms/ivdr-pmpf) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Algorithm Change Protocol(ACP) ](/terms/algorithm-change-protocol) - [Post-Market Surveillance Plan ](/terms/pms-plan) - [Validation Master Plan(VMP) ](/terms/validation-master-plan) [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. Browse - [All terms](/terms) - [A–Z index](/a-z) - [Categories](/categories) - [Ecosystems](/ecosystems) - [Learning paths](/paths) - [Compare terms](/compare) - [Quiz](/quiz) Resources - [FDA Medical Devices](https://www.fda.gov/medical-devices) - [EU MDR](https://eur-lex.europa.eu/eli/reg/2017/745/oj) - [IMDRF](https://www.imdrf.org/) - [Methodology](/methodology) - [Changelog](/changelog) - [Editor: Christian Espinosa](/authors/christian-espinosa) - [About this site](/about) © 2026 MedTech Terms. Reference content for educational purposes - not regulatory advice. A community resource sponsored by [Blue Goat Cyber](https://bluegoatcyber.com)