--- title: "ECO / ECN, Engineering Change Order / Notice | MedTech Terms" description: "Documents that authorize and communicate changes to released designs, BOMs, or manufacturing processes. Plain-English Manufacturing definition for MedTech teams" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eco-ecn#term", "name": "Engineering Change Order / Notice", "alternateName": "ECO / ECN", "description": "ECO/ECN processes are the practical mechanism behind the 21 CFR 820.30(i) and ISO 13485 §7.3.9 design change requirements. 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[Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Manufacturing](/terms?cat=Manufacturing) 6. / 7. Engineering Change Order / Notice [All terms](/terms) Manufacturing [Manufacturing & Supply](/ecosystems/manufacturing-supply)ECO / ECN # Engineering Change Order / Notice Documents that authorize and communicate changes to released designs, BOMs, or manufacturing processes. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition ECO/ECN processes are the practical mechanism behind the 21 CFR 820.30(i) and [ISO 13485](/terms/iso-13485) §7.3.9 design change requirements. They link the change request to impact analysis, approvals, training, and effectivity. What the regulation says Regulators view Engineering Change Orders (ECOs) or Engineering Change Notices (ECNs) as critical controls for managing design changes throughout a medical device's lifecycle. The FDA's 21 CFR 820.30(i) mandates procedures for design changes, while [ISO 13485](/terms/iso-13485):2016 clause 7.3.9 requires control of design and development changes. These regulations emphasize documenting, verifying, validating, and approving changes before implementation, ensuring continued safety and effectiveness of the device. ## What this means in practice PLM systems automate ECO routing; weak effectivity tracking leads to mixed-revision inventory and field issues. ## Examples - An ECO is initiated to update the firmware of an infusion pump to fix a software bug identified during post-market surveillance, requiring re-validation and regulatory submission. - An ECN is raised to change a material supplier for a critical component of a surgical instrument, necessitating a re-evaluation of biocompatibility and performance. - A manufacturer uses an ECO to implement a minor aesthetic change to a device’s packaging, which still requires documented approval but may not trigger extensive re-testing. Common pitfalls - • Failing to assess the full impact of a change across all relevant product documentation, manufacturing processes, and supplier agreements is a common pitfall. - • Implementing a change without adequate verification or validation can lead to product non-conformities and patient safety issues. - • Not involving all necessary stakeholders, such as regulatory, quality, R&D, and manufacturing teams, in the ECO/ECN process can result in overlooked requirements or implementation challenges. - • Poor control over effectivity dates can result in mixed inventory, making it difficult to trace which product versions are in the field and comply with specific change implementations. - • Treating minor changes with the same rigorous process as major ones, or conversely, not giving sufficient attention to cumulative minor changes, can bottleneck operations or introduce uncontrolled risk. ## Frequently asked questions What is the primary purpose of an ECO/ECN in MedTech? The primary purpose is to provide a structured and documented process for managing alterations to a medical device's design, specifications, or manufacturing processes, ensuring compliance with regulatory requirements and maintaining product safety and efficacy. How do ECO/ECNs relate to risk management? What role does traceability play in the ECO/ECN process? When is an ECO/ECN typically initiated? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Quality & Risk Change Control Formal QMS process for evaluating, approving, and implementing changes that could affect product quality or compliance. ](/terms/change-control)[ Quality & Risk Design Controls Structured process governing the design of medical devices. ](/terms/design-controls) ### More in Manufacturing · Same category [ Manufacturing Bill of Materials(BOM) Structured list of every component, sub-assembly, and quantity needed to manufacture a device. ](/terms/bom)[ Manufacturing Bioburden Quantification of viable microorganisms on or in a product before sterilization. ](/terms/bioburden)[ Manufacturing Cleanroom Classes (ISO 14644) ISO 14644 classification of cleanrooms by airborne particulate cleanliness (ISO 1 through ISO 9). ](/terms/cleanroom-iso-14644)[ Manufacturing Container Closure Integrity(CCI) Demonstration that a sterile package maintains microbial barrier and contents integrity over the labeled shelf life. ](/terms/container-closure) Cited by Where this term appears across MedTech Terms. Ecosystems (1) - [Manufacturing & Supply](/ecosystems/manufacturing-supply) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 eCFR· 1 FDA· 1 ISO· 1 1. [1 21 CFR 820.30(i) Verified eCFR · ecfr.gov ](https://www.ecfr.gov/current/title-21/chapter-I/subchapter-H/part-820) 2. [2 FDA - Device Manufacturing Verified FDA · fda.gov ](https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/postmarket-requirements-devices) 3. [3 ISO 13485 Standard Page Verified ISO · iso.org ](https://www.iso.org/iso-13485-medical-devices.html) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Production controls for connected devices? We help device manufacturers operationalize cybersecurity in design transfer, production, and supplier controls. [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 Manufacturing Acronym ECO / ECN Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=eco-ecn) Learn in 60 seconds Card Lesson Quiz Documents that authorize and communicate changes to released designs, BOMs, or manufacturing processes. - · PLM systems automate ECO routing; weak effectivity tracking leads to mixed-revision inventory and field issues. - · They link the change request to impact analysis, approvals, training, and effectivity. Remember this Watch out: Failing to assess the full impact of a change across all relevant product documentation, manufacturing processes, and supplier agreements is a common pitfall. Related terms - [Change Control ](/terms/change-control) - [Design Controls ](/terms/design-controls) You may also need Auto-suggested from Manufacturing and shared keywords. - [Bill of Materials(BOM) ](/terms/bom) - [Technology Transfer (Manufacturing) ](/terms/tech-transfer) - [MLOps for Medical Devices(MLOps) ](/terms/mlops-medical-device) - [Production and Process Controls ](/terms/production-process-controls) - [Real-Time PMA Supplement Review ](/terms/pma-real-time-review) - [Design Transfer ](/terms/design-transfer) [All Manufacturing terms](/terms?cat=Manufacturing) MedTech Terms An authoritative, plain-language reference for the regulatory, quality, cybersecurity, and software terms that shape modern medical devices. 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