--- title: "Class D Batch Verification (IVDR)… | MedTech Terms" description: "Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated." lang: en json-ld: | { "@context": "https://schema.org", "@graph": [ { "@type": "DefinedTerm", "@id": "https://medtechterms.com/terms/ivdr-class-d-batch-verification#term", "name": "Class D Batch Verification (IVDR)", "description": "Article 48(5) and Article 100 require that, for Class D devices where Common Specifications or, in their absence, harmonised standards exist and an EU Reference Laboratory has been designated for the device type, the manufacturer must have each batch tested by the EU RL before release. 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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Class D Batch Verification (IVDR) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Global Markets](/ecosystems/global-markets) # Class D Batch Verification (IVDR) Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 48(5) and Article 100 require that, for Class D devices where [Common Specifications](/terms/common-specifications) or, in their absence, harmonised standards exist and an EU Reference Laboratory has been designated for the device type, the manufacturer must have each batch tested by the EU RL before release. The EU RL verifies that the batch meets the applicable CS or the manufacturer's declared performance. What the regulation says Article 100(2)(a) tasks EU Reference Laboratories with verifying, by laboratory testing, the performance claimed by manufacturers and the conformity of devices with applicable CS or other solutions chosen by manufacturers. ## What this means in practice This is one of the strictest controls in EU device regulation and mirrors requirements historically used for blood-typing and infectious-disease screening. Manufacturers must build EU RL turnaround time into release planning and negotiate service-level expectations early. ## Related terms Grouped by theme ### Editor's picks · Hand-selected related concepts [ Regulatory Common Specifications (IVDR)(CS) Technical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used. ](/terms/ivdr-common-specifications)[ Regulatory EU In Vitro Diagnostic Regulation(IVDR) Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU. ](/terms/ivdr)[ Regulatory EU Reference Laboratory (EURL)(EURL) Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice. ](/terms/ivdr-eu-reference-laboratory)[ Regulatory IVDR Risk Classes A–D EU IVDR's risk-based classification: Class A (lowest) to Class D (highest). ](/terms/ivdr-classes) ### 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: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 European Commission· 1 IMDRF· 1 1. [1 Regulation (EU) 2017/746, Articles 48(5) and 100 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 Commission Implementing Regulation designating EU RLs Unchecked European Commission health.ec.europa.eu ](https://health.ec.europa.eu/medical-devices-sector/new-regulations/eu-reference-laboratories_en) 3. [3 IMDRF Documents Verified IMDRF imdrf.org ](https://www.imdrf.org/documents) 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-class-d-batch-verification) Learn in 60 seconds Card Lesson Quiz Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated. - · This is one of the strictest controls in EU device regulation and mirrors requirements historically used for blood-typing and infectious-disease screening. - · Manufacturers must build EU RL turnaround time into release planning and negotiate service-level expectations early. - · The EU RL verifies that the batch meets the applicable CS or the manufacturer's declared performance. Remember this Article 100(2)(a) tasks EU Reference Laboratories with verifying, by laboratory testing, the performance claimed by manufacturers and the conformity of devices with applicable CS or other solutions chosen by manufacturers. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [Common Specifications (IVDR)(CS) ](/terms/ivdr-common-specifications) You may also need Auto-suggested from Regulatory and shared keywords. - [IVDR Conformity Assessment Routes ](/terms/ivdr-conformity-assessment-routes) - [Notified Body Scrutiny (IVDR Class D) ](/terms/ivdr-notified-body-scrutiny) - [Post-Market Surveillance Plan (IVDR) ](/terms/ivdr-pms-plan) - [CE Mark ](/terms/ce-mark) - [Genetic Testing Requirements (IVDR Article 4) ](/terms/ivdr-genetic-testing) - [Performance Study Application (IVDR) ](/terms/ivdr-performance-study-application) [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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