IVDR Conformity Assessment Routes
The Annex IX, X, and XI procedures a manufacturer chooses to demonstrate IVDR compliance based on device class.
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 scrutiny plus, where applicable, EU Reference Laboratory batch verification and Common Specifications compliance.What this means in practice
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.- •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 themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
International standard for medical device quality management systems.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
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.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2017/746, Articles 48 to 50VerifiedEUR-Lexeur-lex.europa.eu
- 2
IMDRF DocumentsVerifiedIMDRFimdrf.org
- 3
RAPS Regulatory FocusVerifiedRAPSraps.org
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