--- title: "NB, Notified Body | MedTech Terms" description: "EU-designated organization that assesses conformity of medical devices under MDR and IVDR. Plain-English Regulatory definition for MedTech teams, with examples" lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/notified-body#term", "name": "Notified Body", "alternateName": "NB", "description": "A Notified Body is an organization designated by an EU Member State competent authority (and listed in NANDO) to carry out conformity assessment tasks under Regulation (EU) 2017/745 (MDR) or 2017/746 (IVDR) before a device is placed on the EU market. 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They are distinct from EU Notified Bodies, though many organizations hold both designations." } } ] } ] } --- [ MedTech Terms The authoritative reference ](/) Browse Learn [Latest](/latest) About 1. [Home](/) 2. / 3. [Terms](/terms) 4. / 5. [Regulatory](/terms?cat=Regulatory) 6. / 7. Notified Body [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets)NB # Notified Body EU-designated organization that assesses conformity of medical devices under MDR and IVDR. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed May 5, 2026 ## Definition A Notified Body is an organization designated by an EU Member State competent authority (and listed in NANDO) to carry out conformity assessment tasks under Regulation (EU) 2017/745 ( [MDR](/terms/mdr-reporting)) or 2017/746 ( [IVDR](/terms/ivdr)) before a device is placed on the EU market. Designation itself is governed by Implementing Regulation (EU) 2017/2185 and the joint assessment process. What the regulation says Under the [EU Medical Device Regulation](/terms/mdr) ( [MDR](/terms/mdr-reporting) 2017/745) and In Vitro Diagnostic Regulation ( [IVDR](/terms/ivdr) 2017/746), Notified Bodies are conformity assessment bodies designated and monitored by national authorities to ensure that MedTech products meet the necessary safety and performance requirements before market placement. Their responsibilities include auditing manufacturers' quality management systems, assessing technical documentation, and issuing CE certificates, as detailed in MDR Annex VII and IVDR Annex VII. ## What this means in practice Under [MDR](/terms/mdr-reporting)/ [IVDR](/terms/ivdr), Notified Body involvement is required for all devices above Class I (non-sterile, non-measuring, non-reusable surgical) and above [IVD](/terms/ivd) Class A non-sterile. As of 2026 there are approximately 50 MDR-designated and 15 IVDR-designated Notified Bodies, versus 80+ under the prior directives, which has driven multi-year queue times. The Commission and [MDCG](/terms/mdcg) have issued repeated guidance (MDCG 2022-4, MDCG 2022-14, MDCG 2023-3) to increase capacity. Notified Bodies audit the quality management system, review technical documentation, issue CE certificates (valid up to 5 years), and conduct annual surveillance audits including unannounced audits per Implementing Regulation (EU) 2013/920. ## Examples - BSI (UK/NL), TUV SUD (DE), TUV Rheinland (DE), DEKRA (DE), DNV (NO), IMQ (IT) are among the most active MDR Notified Bodies. - A Class IIb implantable receives Annex IX Chapter II technical documentation assessment on a representative device from each generic device group. - Class III and implantables trigger scrutiny procedure (Article 54) and expert panel consultation for certain novel devices. Common pitfalls - • Submitting incomplete technical documentation. Notified Bodies charge for each round of review and clock the review time against contractual SLAs. - • Assuming a legacy MDD/IVDD Notified Body will automatically be designated for MDR/IVDR. Designation is per-code and per-regulation. - • Not planning for unannounced audits at critical suppliers. Article 44 of MDR requires the manufacturer to ensure the Notified Body has access. - • Confusing Notified Body with Competent Authority. Notified Bodies do conformity assessment; Competent Authorities do market surveillance and vigilance oversight. ## Frequently asked questions How do I choose a Notified Body? Match your device MDA/MDN/MDS or IVR/IVS/IVT codes to the Notified Body's scope in NANDO. Factor in queue length, language, cost, and prior sector experience (active implantables, IVDs, software) - these vary widely. Can I switch Notified Bodies? What happens when a Notified Body withdraws designation? Is a UK Approved Body the same? ## Cross-references ### Used by Things that build on this term. - [ EU Medical Device Regulation(MDR) ](/terms/mdr) ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ 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 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) ### EU MDR Essentials · From this learning path [ 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)[ Regulatory Unique Device Identification(UDI) System for adequate identification of medical devices through distribution and use. ](/terms/udi?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) ### 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 IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes?from=ivdr-essentials)[ Clinical & Trials Clinical Evaluation Plan(CEP) 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). ](/terms/clinical-evaluation-plan?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) Cited by Where this term appears across MedTech Terms. Learning paths (2) - [EU MDR Essentials](/paths/eu-mdr-essentials)Lesson 4 of 9 - [IVDR Essentials](/paths/ivdr-essentials)Lesson 5 of 13 Ecosystems (2) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 1 verified 2 unchecked · last checked 2026-06-20 European Commission· 1 MDCG· 1 EUR-Lex· 1 1. [1 NANDO Notified Body database Unchecked European Commission · ec.europa.eu ](https://ec.europa.eu/growth/tools-databases/nando/) 2. [2 MDCG 2022-11 Notified Body transfer Unchecked MDCG · health.ec.europa.eu ](https://health.ec.europa.eu/document/download/) 3. [3 Regulation (EU) 2017/745 Chapter IV Verified EUR-Lex · eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/745/oj) 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 NB Sources 3 Updated 5/5/2026 [Compare with another term](/compare?a=notified-body) Learn in 60 seconds Card Lesson Quiz EU-designated organization that assesses conformity of medical devices under MDR and IVDR. - · Under MDR/IVDR, Notified Body involvement is required for all devices above Class I (non-sterile, non-measuring, non-reusable surgical) and above IVD Class A non-sterile. - · As of 2026 there are approximately 50 MDR-designated and 15 IVDR-designated Notified Bodies, versus 80+ under the prior directives, which has driven multi-year queue times. - · The Commission and MDCG have issued repeated guidance (MDCG 2022-4, MDCG 2022-14, MDCG 2023-3) to increase capacity. Remember this Watch out: Submitting incomplete technical documentation. Notified Bodies charge for each round of review and clock the review time against contractual SLAs. Related terms - [EU Medical Device Regulation(MDR) ](/terms/mdr) - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [CE Mark ](/terms/ce-mark) - [EUDAMED ](/terms/eudamed) You may also need Auto-suggested from Regulatory and shared keywords. - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [IVDR Transitional Provisions ](/terms/ivdr-transitional-provisions) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) [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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