The in vitro diagnostics regulation and the role of medical writers (original) (raw)
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The JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database, aimed to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in house laboratory-developed devices and related test methods for COVID-19, is here presented. The database, manually curated and regularly updated, has been developed as a follow-up to the Communication from the European Commission “Guidelines on in vitro diagnostic tests and their performance” of 15 April 2020 and is freely accessible at https://covid-19-diagnostics.jrc.ec.europa.eu/.
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In vitro diagnostic devices (IVDs) help clinicians determine specific conditions, monitor therapeutic efficacy, and prevent drug resistance development. While stringent regulatory authorities (SRAs) regulate IVDs in most high-income countries, regulatory authorities in many low-and middle-income countries (LMICs) are nonexistent or do not enforce rigorous standards. In 2010, the World Health Organization established its Prequalification of In Vitro Diagnostics (PQDx) program to ensure "access to safe, appropriate and affordable" IVDs, especially in LMICs with little or no domestic regulatory frameworks, thereby reaching underserved populations. However, challenges in PQDx policies and procedures include an overloaded pipeline, timelines not publicly available, confusion about which products PQDx focuses on, perceived burden for documenting changes to prequalified products, overlap with SRA approvals, and uncertainty around long-term financing. PQDx can maximize its impact by considering the perspective of IVD manufacturers; similarly, IVD manufacturers should exercise adequate quality control over their submissions and associated processes.
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The JRC COVID-19 In Vitro Diagnostic Devices and Test Methods Database, aimed to collect in a single place all publicly available information on performance of CE-marked in vitro diagnostic medical devices (IVDs) as well as in house laboratory-developed devices and related test methods for COVID-19, is here presented. The database, manually curated and regularly updated, has been developed as a follow-up to the Communication from the European Commission "Guidelines on in vitro diagnostic tests and their performance" of 15 April 2020 and is freely accessible at https://covid-19-diagnostics.jrc.ec.europa.eu/.
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Companion diagnostics (CDx) hail promise of improving the drug development process and precision medicine. However, there are various challenges involved in the clinical development and regulation of CDx, which are considered high-risk in vitro diagnostic medical devices given the role they play in therapeutic decision-making and the complications they may introduce with respect to their sensitivity and specificity. The European Union (E.U.) is currently in the process of bringing into effect in vitro Diagnostic Medical Devices Regulation (IVDR). The new Regulation is introducing a wide range of stringent requirements for scientific validity, analytical and clinical performance, as well as on post-market surveillance activities throughout the lifetime of in vitro diagnostics (IVD). Compliance with General Safety and Performance Requirements (GSPRs) adopts a risk-based approach, which is also the case for the new classification system. This changing regulatory framework has an impact on all stakeholders involved in the IVD Industry, including Authorized Representatives, Distributors, Importers, Notified Bodies, and Reference Laboratories and is expected to have a significant effect on the development of new CDx.
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In Europe there are very high expectations regarding the quality, safety, and efficacy of medical devices. But in reality, it fails, due to many scandals that threatened the lives of thousands of people. So, the EU has introduced the new regulations in medical devices to meet the expectations. The old directives such as medical device directive (MDD) and active implantable medical device directive (AIMDD) are now replaced with medical device regulation (MDR), and in vitro diagnostic medical device directive (IVDD) is replaced with in vitro diagnostic regulation (IVDR). When compared to MDR there are more significant changes introduced in the IVDR. The New Regulations has a hard deadline for certifications and manufacturers cannot launch their product without certification, hence manufacturers have to meet the new regulations within the given time frame. The change in regulation brings a disturbance for the medical device industry. The manufacturers have to make strategic decisions t...