Sampling under In Vitro Diagnostics Regulation: MedTech Europe proposal for a more risk-based approach

Posted on 30.07.2025

The amount of paperwork required for In vitro diagnostic (IVD) manufacturers has increased substantially since the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) came into force. ​

Notified Bodies assess technical documentation of Class B and Class C IVDs used by laboratory professionals, through sampling during their certificate lifetime. Today, Notified Bodies dedicate most of their time in sampling lower risk Class B and Class C devices, rather than highest risk Class D devices. ​

In this reflection paper, MedTech Europe argues that sampling should be made more proportionate to the risk classes of devices. It should take into account the composition of the IVD market, the current sampling criteria for Class B and Class C devices, and ensure a focus on higher risk devices. Duplication of review should be avoided.​

Mandating a high percentage of sampling for Class B and Class C devices in each certification cycle, places a disproportionate burden on IVD manufacturers. This burden is particularly high for Small & Medium Sized Enterprises (SMEs) which have a limited portfolio, meaning that the same devices are reviewed repeatedly. ​

MedTech Europe calls on the Medical Device Coordination Group to adopt a risk-based rather than quota-based sampling approach for Class B and Class C devices to reduce the burden stemming from duplicative sampling and focus the resources of the system on higher risk devices.​

Read our reflection paper on Sampling under IVDR below.​