Since the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into effect, the administrative workload for IVD manufacturers has increased significantly. Under the IVDR, Notified Bodies are required to review the technical documentation for Class B and Class C IVDs (used by laboratory professionals) through sampling during the validity of their certificates.
Currently, most of the effort by Notified Bodies is focused on sampling lower-risk Class B and C devices, rather than on higher-risk Class D devices, which raises concerns about the proportionality and efficiency of the system.
In its reflection paper, MedTech Europe argues that sampling practices should be better aligned with the actual risk levels of devices. The approach should consider:
- The overall composition of the IVD market
- Existing sampling criteria for Class B and C devices
- The need to prioritize high-risk devices (Class D)
A rigid requirement to sample a high percentage of Class B and C devices during each certification cycle places an unfair burden on manufacturers, especially SMEs with smaller product portfolios. These companies often face repeated reviews of the same devices, leading to inefficiencies and unnecessary duplication.
To address this, MedTech Europe urges the Medical Device Coordination Group (MDCG) to shift from a quota-based to a risk-based sampling approach. This would help reduce redundant assessments, ease the regulatory burden on manufacturers—particularly SMEs—and allow the system to focus its resources on devices that pose higher risks to patients and public health.
The full position paper can be accessed using the following link
