MedTech Europe calls for technical documentation sampling of In Vitro diagnostics to become more risk-based

Posted on 04.09.2025

Current European guidelines on technical documentation sampling for In Vitro diagnostics (IVD) under the In Vitro Diagnostic Medical Devices Regulation 2017/746/EU (IVDR) place a disproportionate administrative burden on mid- to lower-risk class devices.

Notified Bodies are required to sample up to 15% of technical documentation for these devices per cycle every five years. Since these devices make up over 90% of the EU IVD market, Notified Bodies are spending most of their time reviewing (often repeatedly) technical documentation of lower rather than highest risk class IVDs.

This is not risk proportionate and particularly affects smaller companies with only a few products, whose tests may be reviewed repeatedly. For small businesses, a single review can cost tens of thousands of euros, which in some cases amounts to a significant share of their annual revenue, diverting resources from innovation.

MedTech Europe calls on the Medical Device Coordination Group to adopt a more-risk based approach, focusing reviews on the highest-risk tests where patient safety is most critical, avoiding unnecessary duplicate assessments, and reducing costs and paperwork for smaller businesses.

You can read MedTech Europe’s full position paper on IVD sampling under the IVDR here.