Class D Batch Verification (IVDR)
Pre-release testing of every manufactured batch of Class D IVDs by an EU Reference Laboratory, where designated.
Definition
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. The EU RL verifies that the batch meets the applicable CS or the manufacturer's declared performance.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 themeEditor's picks
· Hand-selected related conceptsTechnical or clinical requirements adopted by Commission implementing act that manufacturers must comply with unless a demonstrably equivalent alternative is used.
Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Laboratory designated by the Commission to verify performance of Class D IVDs and provide scientific advice.
EU IVDR's risk-based classification: Class A (lowest) to Class D (highest).
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(5) and 100VerifiedEUR-Lexeur-lex.europa.eu
- 2
Commission Implementing Regulation designating EU RLsUncheckedEuropean Commissionhealth.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.