--- title: "MDR, EU Medical Device Regulation | MedTech Terms" description: "Regulation (EU) 2017/745 governing medical devices in the European Union. Plain-English Regulatory definition for MedTech teams, with examples and related terms" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/mdr#term", "name": "EU Medical Device Regulation", "alternateName": "MDR", "description": "Regulation (EU) 2017/745 (MDR) lays down rules concerning the placing on the market, making available, and putting into service of medical devices for human use and accessories, replacing the previous Medical Devices Directive (MDD).", "url": "https://medtechterms.com/terms/mdr", "termCode": "mdr", "inDefinedTermSet": { "@type": "DefinedTermSet", "name": "MedTech Terms", "url": "https://medtechterms.com/terms" } }, { "@type": "Article", "@id": "https://medtechterms.com/terms/mdr#article", "headline": "MDR, EU Medical Device Regulation", "description": "Regulation (EU) 2017/745 governing medical devices in the European Union.", "url": "https://medtechterms.com/terms/mdr", "mainEntityOfPage": { "@type": "WebPage", "@id": "https://medtechterms.com/terms/mdr" }, "about": { "@id": "https://medtechterms.com/terms/mdr#term" }, "articleSection": "Regulatory", "inLanguage": "en", "keywords": "EU Medical Device Regulation, MDR, Regulatory, 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": "2026-05-05", "dateModified": "2026-05-05", "citation": [ { "@type": "CreativeWork", "name": "Regulation (EU) 2017/745", "url": "https://eur-lex.europa.eu/eli/reg/2017/745/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "Regulation (EU) 2023/607 (MDR transition extension)", "url": "https://eur-lex.europa.eu/eli/reg/2023/607/oj", "publisher": { "@type": "Organization", "name": "EUR-Lex" } }, { "@type": "CreativeWork", "name": "MDCG Guidance Documents", "url": "https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en", "publisher": { "@type": "Organization", "name": "European Commission" } } ], "mentions": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr#term", "name": "EU In Vitro Diagnostic Regulation", "alternateName": "IVDR", "url": "https://medtechterms.com/terms/ivdr" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/notified-body#term", "name": "Notified Body", "alternateName": "NB", "url": "https://medtechterms.com/terms/notified-body" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/udi#term", "name": "Unique Device Identification", "alternateName": "UDI", "url": "https://medtechterms.com/terms/udi" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/eudamed#term", "name": "EUDAMED", "url": "https://medtechterms.com/terms/eudamed" }, { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ce-mark#term", "name": "CE Mark", "url": "https://medtechterms.com/terms/ce-mark" }, { "@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/pmcf#term", "name": "Post-Market Clinical Follow-up", "alternateName": "PMCF", "url": "https://medtechterms.com/terms/pmcf" } ] }, { "@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": "Regulatory", "item": "https://medtechterms.com/terms?cat=Regulatory" }, { "@type": "ListItem", "position": 4, "name": "EU Medical Device Regulation", "item": "https://medtechterms.com/terms/mdr" } ] }, { "@type": "FAQPage", "@id": "https://medtechterms.com/terms/mdr#faq", "mainEntity": [ { "@type": "Question", "name": "What is the difference between MDR and the MDD?", "acceptedAnswer": { "@type": "Answer", "text": "MDR (Regulation (EU) 2017/745) replaced the Medical Devices Directive (93/42/EEC) in 2021. 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Most such software is Class IIa or higher, with Class III applied when decisions may cause death or irreversible deterioration." } }, { "@type": "Question", "name": "What are the MDR transition deadlines?", "acceptedAnswer": { "@type": "Answer", "text": "Regulation (EU) 2023/607 extended MDD certificates: Class III and implantable Class IIb through 31 December 2027, and Class IIa, Class IIb non-implantable, and Class I devices requiring Notified Body involvement through 31 December 2028, provided manufacturers have applied to a Notified Body by set deadlines and meet other conditions." } }, { "@type": "Question", "name": "Do I need a Notified Body under MDR?", "acceptedAnswer": { "@type": "Answer", "text": "Yes for every device above Class I. Class I sterile, measuring, and reusable surgical devices also require Notified Body involvement (for the sterility, metrology, or reprocessing aspects respectively)." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. EU Medical Device Regulation [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)MDR # EU Medical Device Regulation Regulation (EU) 2017/745 governing medical devices in the European Union. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition Regulation (EU) 2017/745 ( [MDR](/terms/mdr-reporting)) lays down rules concerning the placing on the market, making available, and putting into service of medical devices for human use and accessories, replacing the previous Medical Devices Directive (MDD). ## What this means in practice [MDR](/terms/mdr-reporting) introduces stricter clinical evidence requirements, stronger [post-market surveillance](/terms/post-market-surveillance), [UDI](/terms/udi), [EUDAMED](/terms/eudamed) registration, and an enhanced role for Notified Bodies. Many devices have undergone reclassification, especially software (Rule 11 pushes most standalone medical software to Class IIa or higher). Transitional provisions extended MDD certificate validity for legacy devices through May 2027 (Class III and implantable Class IIb) and December 2028 (other classes) provided conditions in Regulation (EU) 2023/607 are met. ## Examples - A Class IIa mobile app for insulin dose calculation that would have been Class I under the MDD, reclassified under MDR Rule 11. - A legacy implantable cardiac device sold under an MDD certificate, extended through May 2027 under the Regulation (EU) 2023/607 transition, with a Notified Body application filed by the required deadline. ## Use cases 1 scenario 1 ### Class IIb device transitioning from MDD to EU MDR Regulatory & Clinical The manufacturer expands clinical evaluation, refreshes the technical file to [MDR](/terms/mdr-reporting) Annex II/III, signs a [notified body](/terms/notified-body) contract, and registers the device and economic operators in [EUDAMED](/terms/eudamed). Outcome CE marking under [MDR](/terms/mdr-reporting) is issued before the legacy MDD certificate expires, avoiding a supply gap. Common pitfalls - • Assuming Rule 11 does not apply. Most software providing information used for decisions with a diagnostic or therapeutic purpose is now Class IIa or higher. - • Missing the transition deadlines and Notified Body application windows in Regulation (EU) 2023/607. - • Under-scoping clinical evidence. MDR expects a Clinical Evaluation Plan and ongoing Post-Market Clinical Follow-up (PMCF), not a one-time literature review. - • Treating a Person Responsible for Regulatory Compliance (PRRC) role as optional. It is mandatory for manufacturers and authorized representatives. ## Frequently asked questions What is the difference between MDR and the MDD? [MDR](/terms/mdr-reporting) (Regulation (EU) 2017/745) replaced the Medical Devices Directive (93/42/EEC) in 2021. Key changes: stricter clinical evidence, mandatory [UDI](/terms/udi) and [EUDAMED](/terms/eudamed) registration, reclassification of many devices (especially software under Rule 11), lifecycle [post-market surveillance](/terms/post-market-surveillance), and a [PRRC](/terms/prrc) role. What is Rule 11 under EU MDR? What are the MDR transition deadlines? Do I need a Notified Body under MDR? ## Cross-references ### Uses Concepts or artefacts this term builds on. - [ CE Mark ](/terms/ce-mark) - [ Notified Body(NB) ](/terms/notified-body) - [ EUDAMED ](/terms/eudamed) ### Contains Sub-elements or required artefacts of this term. - [ Clinical Evaluation Report(CER) ](/terms/cer) - [ Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) - [ Periodic Safety Update Report(PSUR) ](/terms/psur) - [ Summary of Safety and Clinical Performance(SSCP) ](/terms/sscp) ### Often confused with Distinct concept frequently mistaken for this one. - [ EU In Vitro Diagnostic Regulation(IVDR) MDR covers devices; IVDR covers in-vitro diagnostics. ](/terms/ivdr) ## 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 CE Mark Mandatory European conformity mark for medical devices placed on the EU market. ](/terms/ce-mark)[ Regulatory EUDAMED European Database on Medical Devices. ](/terms/eudamed)[ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body) ### EU MDR Essentials · From this learning path [ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi?from=eu-mdr-essentials)[ Post-Market Field Safety Corrective Action(FSCA) Action taken to reduce a risk of serious deterioration in health associated with a device. ](/terms/fsca?from=eu-mdr-essentials)[ Post-Market Medical Device Vigilance Reporting and management of serious incidents and field safety corrective actions. ](/terms/vigilance?from=eu-mdr-essentials)[ Post-Market Periodic Safety Update Report(PSUR) Periodic EU MDR/IVDR report summarizing post-market surveillance findings. ](/terms/psur?from=eu-mdr-essentials) Cited by Where this term appears across MedTech Terms. Learning paths (1) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 1 of 9 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) Comparisons (1) - [EU MDR vs EU IVDR](/compare/mdr-vs-ivdr)vs EU In Vitro Diagnostic Regulation ## Mentioned in recent activity 1 entry PubMed (1) [Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. ](https://pubmed.ncbi.nlm.nih.gov/41915013/) Clinical orthopaedics and related research · 2026-06-01 ## Latest in MedTech [View all](/latest?term=mdr) Recent regulatory actions, publications, and trials matched to this term. Updated daily. - PubMed 2026-06-01 [Few FDA Approved AI/ML Orthopaedic Devices Have EU MDR Equivalents or Peer-Reviewed Validation. ](https://pubmed.ncbi.nlm.nih.gov/41915013/) Clinical orthopaedics and related research ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 2 European Commission· 1 1. [1 Regulation (EU) 2017/745 Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 2. [2 Regulation (EU) 2023/607 (MDR transition extension) Unchecked EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2023/607/oj) 3. [3 MDCG Guidance Documents 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) 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 MDR Sources 3 Use cases 1 Updated 5/5/2026 [Compare with another term](/compare?a=mdr) Learn in 60 seconds Card Lesson Quiz Regulation (EU) 2017/745 governing medical devices in the European Union. - · MDR introduces stricter clinical evidence requirements, stronger post-market surveillance, UDI, EUDAMED registration, and an enhanced role for Notified Bodies. - · Many devices have undergone reclassification, especially software (Rule 11 pushes most standalone medical software to Class IIa or higher). Remember this Watch out: Assuming Rule 11 does not apply. Most software providing information used for decisions with a diagnostic or therapeutic purpose is now Class IIa or higher. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [Notified Body(NB) ](/terms/notified-body) - [Unique Device Identification(UDI) ](/terms/udi) - [EUDAMED ](/terms/eudamed) - [CE Mark ](/terms/ce-mark) - [Medical Device Coordination Group Guidance(MDCG) ](/terms/mdcg) - [Post-Market Clinical Follow-up(PMCF) ](/terms/pmcf) You may also need Auto-suggested from Regulatory and shared keywords. - [Importer and Distributor Obligations (EU) ](/terms/importer-distributor) - [IVDR Legacy Device ](/terms/ivdr-legacy-device) - [Metrological Traceability (IVDR) ](/terms/ivdr-metrological-traceability) - [Provider and Deployer (EU AI Act) ](/terms/ai-act-provider-deployer) - [UK Responsible Person(UKRP) ](/terms/ukrp) - [AI Act Post-Market Monitoring ](/terms/ai-act-post-market-monitoring) [All Regulatory terms](/terms?cat=Regulatory) From the Blue Goat network Related resources and services on this topic. - [ MedTech Cybersecurity Crosswalk International crosswalk of medical device cybersecurity requirements across regulators. ](https://mdccrosswalk.com) - [ MedTech Cybersecurity Standards Authoritative reference for the standards and guidances behind medical device cybersecurity. ](https://medtechcyberstandards.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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