Exemption of Routine Blood Draws from Article 58.1(a) of the IVDR

MedTech Europe, together with the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and the BioMed Alliance, advocates for a reconsideration of Article 58.1(a) of the In Vitro Diagnostic Medical Devices Regulation (IVDR) as it pertains to performance studies involving routine blood draws. We argue that such studies should not be held to the same regulatory standards as more invasive procedures. While some performance studies under the IVDR involve high-risk procedures, such as tissue biopsies or arterial blood draws, routine venous and capillary blood draws are considered low-to-none-risk and should not fall under the stringent approval processes outlined in Article 58.1(a).

The current regulatory framework has created delays, administrative burdens, and challenges, particularly for small and medium-sized enterprises, impeding the timely introduction of innovative diagnostic tests and treatments to European healthcare systems. Globally, other regulatory bodies have exempted routine blood draws from being classified as invasive, further reinforcing the case for change.

MedTech Europe proposes that routine venous and capillary blood draws from the general population be excluded from the scope of Article 58.1(a). Such a change would streamline the regulatory process for these studies, speeding up access for patients to new in vitro diagnostic devices, while ensuring patient safety and ethical standards are upheld. Revising Article 58.1(a) to exclude low-risk blood draw studies would ease unnecessary burdens on the healthcare system and foster innovation, ultimately benefiting patients across Europe with quicker access to vital diagnostic solutions.