Urgent call to the European Commission to simplify and contextualize IVDR Article 5.5 for tailored and precision diagnostics

What is it about?

In house-IVDs have a vital role in the EU healthcare system. Yet, the IVDR 2017/746 Art 5.5 is not proportionate and brings in its current form a disservice to patients and caregivers in medical settings due to its stringency and not delivering what was intended. It is prime time to reverse the multiple unintended consequences of IVDR Art 5.5. and to scrutinize its requirements, taking into account the real-world context of medical laboratories in healthcare institutions, staffed with diagnostic laboratory specialists performing different modes of IH-IVDs under risk-averse quality management systems in accredited laboratories for up to three decades.Failure to systemically amend Art 5.5. will increase healthcare costs, jeopardize the ability to design “personalized” laboratory tests, discriminate patients with metabolic and/or rare diseases, stop innovation and withhold essential and/or tailored diagnostic services to caregivers.

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