--- title: "MDCG Definition & Meaning | MedTech Terms" description: "Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements. 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Medical Device Coordination Group Guidance [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)MDCG # Medical Device Coordination Group Guidance Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition The MDCG, composed of competent authority representatives, issues numbered guidance documents (MDCG 2019-x, MDCG 2021-x, etc.) covering classification, clinical evaluation, vigilance, software, AI, and many other [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr) topics. What the regulation says The Medical Device Coordination Group (MDCG) is an expert group established under Article 105 of the [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting)) and Article 99 of the [EU In Vitro Diagnostic Regulation](/terms/ivdr) (IVDR). While MDCG guidance documents are not legally binding, they represent the common understanding and interpretation of the regulations by EU member states and the European Commission, serving as de-facto standards for compliance. ## What this means in practice MDCG documents are not legally binding but set the de-facto interpretive baseline for Notified Bodies and competent authorities; ignoring them is risky. ## Examples - A manufacturer consults MDCG 2019-11, Guidance on Qualification and Classification of Software, to determine the correct classification of their new diagnostic mobile application under the EU MDR. - During a Notified Body audit, the auditor references MDCG 2020-13, Clinical Evaluation: A Guide for Manufacturers and Notified Bodies, to assess the adequacy of a device's Clinical Evaluation Report (CER). - A company preparing a Post-Market Surveillance (PMS) plan reviews MDCG 2022-21, Guidance on Post-Market Surveillance (PMS) Plan for Manufacturers and other economic operators, to ensure all required elements are included. Common pitfalls - • Ignoring MDCG guidance can lead to non-conformities during audits or market access delays, even though the guidance is not legally binding. - • Misinterpreting the scope or applicability of a specific MDCG document can result in misallocation of resources or incomplete compliance efforts. - • Failing to track updates or new MDCG documents can leave a manufacturer unaware of evolving regulatory expectations. - • Assuming national competent authorities will always align their interpretation perfectly with MDCG guidance without further clarification can lead to errors. - • Treating MDCG guidance as optional rather than an integral part of interpreting and applying the MDR/IVDR is a common pitfall. ## Frequently asked questions Are MDCG guidance documents legally binding? No, MDCG guidance documents are not legally binding. However, they establish the common understanding and interpretation of the EU [MDR](/terms/mdr-reporting) and [IVDR](/terms/ivdr) by Member States and the European Commission. What is the purpose of MDCG guidance? Who issues MDCG guidance? ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory EU Medical Device Regulation(MDR) Regulation (EU) 2017/745 governing medical devices in the European Union. ](/terms/mdr) ### More in Regulatory · Same category [ Regulatory 510(k) Premarket Notification(510(k)) FDA submission demonstrating a device is substantially equivalent to a legally marketed predicate. ](/terms/510k)[ Regulatory 510(k) Summary vs 510(k) Statement Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request. ](/terms/510k-summary-vs-statement)[ Regulatory 513(g) Request for Information(513(g)) Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification. ](/terms/513g)[ Regulatory Abbreviated 510(k) 510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards. ](/terms/abbreviated-510k) Cited by Where this term appears across MedTech Terms. Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 3 verified · last checked 2026-06-20 European Commission· 1 RAPS· 1 FDA· 1 1. [1 MDCG Guidance Verified European Commission · health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en) 2. [2 RAPS Regulatory Focus Verified RAPS · raps.org ](https://www.raps.org/news-and-articles/news-articles) 3. [3 FDA - Medical Devices Verified FDA · fda.gov ](https://www.fda.gov/medical-devices) Inline markers like \[1\] jump to the matching reference above. Sponsor note ### Navigating an FDA or EU MDR submission? Blue Goat Cyber supports the cybersecurity content of premarket submissions, from threat models to the 524B narrative. [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 Regulatory Acronym MDCG Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=mdcg) Learn in 60 seconds Card Lesson Quiz Guidance documents from the EU-level expert group that interpret MDR/IVDR requirements. - · MDCG documents are not legally binding but set the de-facto interpretive baseline for Notified Bodies and competent authorities; ignoring them is risky. Remember this Watch out: Ignoring MDCG guidance can lead to non-conformities during audits or market access delays, even though the guidance is not legally binding. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) You may also need Auto-suggested from Regulatory and shared keywords. - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) - [In-House IVDs (Article 5(5)) ](/terms/ivdr-in-house-devices) - [IVDR Performance Evaluation ](/terms/ivdr-performance-evaluation) - [Authorized Representative (EU)(EC REP) ](/terms/ec-rep) - [Common Specifications(CS) ](/terms/common-specifications) - [EUDAMED ](/terms/eudamed) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.com) - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Truths Common misconceptions about medical device development - debunked. ](https://mdcmisconceptions.com) - [ 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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