The European Committee on Organ Transplantation (CD-P-TO) has adopted a critical position paper highlighting the unintended consequences of EU regulations on medical devices (MDR) and in vitro diagnostic devices (IVDR) for the field of substances of human origin (SoHO). The paper warns that the current regulatory framework is leading to the withdrawal of essential diagnostic tools used in donor screening and SoHO preparations, threatening patient safety and service continuity.
The MDR and IVDR were introduced in 2017 with the ambition to establish a robust, transparent, predictable and sustainable regulatory framework, ensuring high standards of safety and healthcare while supporting innovation. However, several years into implementation, these regulations have led to certain unintended consequences, with niche markets disproportionately affected. Many manufacturers, unable to meet the complex and costly requirements of complying with the regulations, have been forced to withdraw critical devices from the market.
The position paper outlines the real-world effects of these unintended consequences: health institutions are being forced to adopt approaches that may not meet current safety and quality standards, such as manual or legacy methods, off-label use and in-house solutions.
This compromises quality of care and risks both reducing the availability of SoHO preparations to treat patients – especially those coming from deceased donors – and stifling innovation.
To address these challenges, the CD-P-TO recommends a proportionate regulatory pathway for niche, low-volume and low-risk devices, clearer guidance on in-house devices and off-label use and the creation of a dynamic list of essential devices to prevent disruptions of supply. It also calls for expanded proficiency testing schemes to include critical niche applications such as deceased-donor blood screening and diagnostics for rare or tropical diseases, and the elaboration of harmonised guidance for emergency preparedness and response for medical devices and in vitro diagnostic tests used in SoHO-related and other niche applications.
This position paper is a call to action for EU institutions and national authorities to safeguard the tools that underpin safe and effective transplantation. It is intended to raise awareness that ensuring regulatory ambition does not come at the cost of patient care and public health.
Read the CD-P-TO position paper: “Risks to safety and quality in donor screening and SoHO preparations due to poor implementation of the MDR and IVDR” (PA/PH/TO (24) 18).
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