Regulatory
Class D Batch Verification (IVDR)
In one line
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.
Why it matters
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.
Common pitfalls
- •Manufacturers may underestimate the time and resources required for EU Reference Laboratory (EU RL) testing, leading to significant delays in product release if not planned effectively.
- •Assuming that internal quality control testing alone is sufficient for Class D devices, neglecting the mandatory independent verification by an EU RL for designated device types.
- •Failure to engage with designated EU RLs early in the development and regulatory planning process to understand their specific requirements and turnaround times.
Sources
- Regulation (EU) 2017/746, Articles 48(5) and 100 · EUR-Lex
- Commission Implementing Regulation designating EU RLs · European Commission
- IMDRF Documents · IMDRF