Abstract
Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from IVDD 98/79/EC (https://eur-lex.eur-opa.eu/legal-content/EN/TXT/?uri=CELEX%3A31998L0079&qid=1628781352814) to IVDR 2017/746 https://eur-lex.europa.eu/eli/reg/2017/746. Without amendments and contingency plans, implementation of the IVDR in May 2022 will lead the healthcare sector into uncharted waters due to unpreparedness of the EU regulatory infrastructure. Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests. Finally, it also may discourage manufacturers and academia from developing specialty tests, thereby hampering innovation in medical diagnostic care. We hereby inform laboratory professionals about the imminent diagnostic collapse using testimonies from representative stakeholders of the diagnostic supply chain and from academia developing innovative in-house tests in domains of unmet clinical needs. Steps taken by the EFLM Task Force on European Regulatory Affairs, under the umbrella of the Biomedical Alliance in Europe, will be highlighted, as well as the search for solutions through dialogue with the European Commission. Although we recognize that the IVDR promotes positive goals such as increased clinical evidence, surveillance, and transparency, we need to ensure that the capabilities of the diagnostic sector are not damaged by infrastructural unpreparedness, while at the same time being forced to submit to a growing bureaucratic and unsupportive structure that will not support its "droit d'exister".
Highlights
Laboratory testing has an acknowledged widespread role in clinical decision-making, and a direct significance in determining patient management and clinical outcomes
Laboratory medicine in the European Union is at the dawn of a regulatory revolution as it reaches the end of the transition from in-vitro diagnostic directive 98/79/EC (IVDD) 98/79/European Commission (EC) to in-vitro diagnostic regulation 2017/746 (IVDR) 2017/746 https://eur-lex. europa.eu/eli/reg/2017/746
Prospective risk analyses were not made by the European Commission, and if nothing happens it can be anticipated that the consequences will impact all stakeholders of the medical test pipeline, may seriously harm patients and may prevent caregivers from making appropriate clinical decisions due to non-availability of medical tests
Summary
Laboratory testing has an acknowledged widespread role in clinical decision-making, and a direct significance in determining patient management and clinical outcomes. The regulation stipulates how manufacturers’ quality management systems are to be designed and what they must include for stricter requirements on technical documentation and post-market surveillance – all adding to the emphasis on the test lifecycle Another change is that all manufacturers, as well as authorised representatives, are required to have a dedicated Person Responsible for Regulatory Compliance with a specified level of relevant training or else work experience corresponding to the training required. Many critical regulatory elements needed to certify IVDs are not in place and important guidance documents are still lacking This makes it unfeasible for stakeholders to prepare in a timely way for the new regulatory environment and thereby secure continuity of diagnostics beyond May 2022. With regard to the financial situation in the health sector in European Countries, it is unlikely that hospital administrations will increase budgets for their laboratoriesincreased expenditures and effort
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