--- title: "IVDR Conformity Assessment Routes… | MedTech Terms" description: "The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-conformity-assessment-routes#term", "name": "IVDR Conformity Assessment Routes", "description": "Articles 48 to 50 map conformity assessment to device class. Class A (non-sterile) is self-declared. Class A sterile, B, and C follow Annex IX (quality management system plus technical documentation assessment) or Annex X (type examination) combined with Annex XI (production quality assurance). 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. IVDR Conformity Assessment Routes [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # IVDR Conformity Assessment Routes The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Articles 48 to 50 map conformity assessment to device class. Class A (non-sterile) is self-declared. Class A sterile, B, and C follow Annex IX (quality management system plus technical documentation assessment) or Annex X (type examination) combined with Annex XI (production quality assurance). Class D requires Annex IX with [notified body](/terms/notified-body) scrutiny plus, where applicable, EU Reference Laboratory batch verification and [Common Specifications](/terms/common-specifications) compliance. What the regulation says Article 48(1) requires manufacturers to draw up an EU declaration of conformity following the conformity assessment procedure appropriate to the class of the device. ## What this means in practice Under the IVDD roughly 20 percent of IVDs required [notified body](/terms/notified-body) involvement; under [IVDR](/terms/ivdr) that figure exceeds 80 percent. Choosing between Annex IX and X+XI is largely a QMS design decision: Annex IX aligns with [ISO 13485](/terms/iso-13485) full-scope certification, while Annex X+XI splits type examination from production oversight. Common pitfalls - • Assuming Class B and C can skip notified body review for technical documentation. Sampling per Annex IX Section 2.3 applies. - • Overlooking the extra Class D duties in Article 48(3) to (6): EU RL batch testing, CS scrutiny, expert-panel consultation for novel devices. ## 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 IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes)[ Regulatory Notified Body(NB) EU-designated organization that assesses conformity of medical devices under MDR and IVDR. ](/terms/notified-body)[ Standards ISO 13485 International standard for medical device quality management systems. ](/terms/iso-13485) ### 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 EUR-Lex· 1 IMDRF· 1 RAPS· 1 1. [1 Regulation (EU) 2017/746, Articles 48 to 50 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 3. [3 RAPS Regulatory Focus Verified RAPS raps.org ](https://www.raps.org/news-and-articles/news-articles) 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 Sources 3 Updated 7/25/2026 [Compare with another term](/compare?a=ivdr-conformity-assessment-routes) Learn in 60 seconds Card Lesson Quiz The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class. - · Under the IVDD roughly 20 percent of IVDs required notified body involvement; under IVDR that figure exceeds 80 percent. - · Choosing between Annex IX and X+XI is largely a QMS design decision: Annex IX aligns with ISO 13485 full-scope certification, while Annex X+XI splits type examination from production oversight. - · Class A (non-sterile) is self-declared. Remember this Watch out: Assuming Class B and C can skip notified body review for technical documentation. Sampling per Annex IX Section 2.3 applies. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [Notified Body(NB) ](/terms/notified-body) - [ISO 13485 ](/terms/iso-13485) You may also need Auto-suggested from Regulatory and shared keywords. - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [AI Act Technical Documentation (Annex IV) ](/terms/ai-act-technical-documentation) - [AI Act Conformity Assessment (Medical Devices) ](/terms/ai-act-conformity-assessment) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [CE Mark ](/terms/ce-mark) [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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