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[Home](/) 2. [Terms](/terms) 3. [Regulatory](/terms?cat=Regulatory) 4. Notified Body Scrutiny (IVDR Class D) [All terms](/terms) Regulatory [Regulated Pathways](/ecosystems/regulated-pathways)[Quality System](/ecosystems/quality-system)[Global Markets](/ecosystems/global-markets) # Notified Body Scrutiny (IVDR Class D) Additional expert-panel review of a notified body's assessment for certain novel or high-risk Class D devices before certification. Reviewed by [Christian Espinosa, Founder, Blue Goat Cyber](/authors/christian-espinosa) Last reviewed July 25, 2026 ## Definition Article 48(6) requires the [notified body](/terms/notified-body) assessing a Class D device to notify a designated expert panel of its Performance Evaluation Assessment Report (PEAR) where no CS exist for the device, the device is the first of its kind, or the CS have been recently revised. The expert panel may deliver a scientific view within 60 days that the notified body must duly consider. What the regulation says Article 48(6) and Article 106 detail the composition and functioning of the expert panels and the procedure by which their scientific views feed back into the [notified body](/terms/notified-body)'s decision. ## What this means in practice Scrutiny is a checkpoint intended to raise consistency across notified bodies for the highest-risk IVDs (HIV, HCV, blood grouping, novel pathogen assays). It borrows the mechanism of [MDR](/terms/mdr-reporting) Article 54 CECP scrutiny for implantable Class III 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) ### 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 (3) - [Regulated Pathways](/ecosystems/regulated-pathways) - [Quality System](/ecosystems/quality-system) - [Global Markets](/ecosystems/global-markets) ## Primary references 3 sources Link health: 2 verified 1 unchecked · last checked 2026-06-20 EUR-Lex· 1 MDCG· 1 RAPS· 1 1. [1 Regulation (EU) 2017/746, Article 48(6) and Article 106 Verified EUR-Lex eur-lex.europa.eu ](https://eur-lex.europa.eu/eli/reg/2017/746/oj) 2. [2 MDCG 2019-3 Interpretation of Article 54(2)(b) MDR (analogous) Unchecked MDCG health.ec.europa.eu ](https://health.ec.europa.eu/latest-updates_en) 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-notified-body-scrutiny) Learn in 60 seconds Card Lesson Quiz Additional expert-panel review of a notified body's assessment for certain novel or high-risk Class D devices before certification. - · Scrutiny is a checkpoint intended to raise consistency across notified bodies for the highest-risk IVDs (HIV, HCV, blood grouping, novel pathogen assays). - · It borrows the mechanism of MDR Article 54 CECP scrutiny for implantable Class III devices. - · The expert panel may deliver a scientific view within 60 days that the notified body must duly consider. Remember this Article 48(6) and Article 106 detail the composition and functioning of the expert panels and the procedure by which their scientific views feed back into the notified body's decision. Related terms - [EU In Vitro Diagnostic Regulation(IVDR) ](/terms/ivdr) - [IVDR Risk Classes A–D ](/terms/ivdr-classes) - [Notified Body(NB) ](/terms/notified-body) You may also need Auto-suggested from Regulatory and shared keywords. - [Class D Batch Verification (IVDR) ](/terms/ivdr-class-d-batch-verification) - [EU Reference Laboratory (EURL)(EURL) ](/terms/ivdr-eu-reference-laboratory) - [Fundamental Rights Impact Assessment(FRIA) ](/terms/ai-act-fria) - [Summary of Safety and Performance (IVDR)(SSP) ](/terms/ivdr-summary-safety-performance) - [High-Risk AI System (EU AI Act) ](/terms/ai-act-high-risk-system) - [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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