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Abstract

THE NEW IN-VITRO DIAGNOSTIC REGULATION (2017/746/EU): CHALLENGE OR AN OPPORTUNITY FOR MANUFACTURERS AND KEY STAKEHOLDERS

Hardeep Singh Kohli* and Supriya Agnihotri

Abstract

about 500,000 kinds of competitive and novel medical and In vitro diagnostic devices (IVD), with mushrooming of small and medium-sized enterprises (SME). Since 1990, on the concept of New Approach, it was regulated by the legal framework of 3 main directives, Directive 90/385/EEC on AIMDD, Medical Device Directive 93/42/EEC (MDD) and Directive 98/79/EC (October 1998 ) on IVDD. With the incident of metal on metal hip prostheses (Aug 2010), transvaginal mesh complications (July 2011), and Breast implant crises (June 2012), the need for a revision process started in 2012. In May 2017, the two new regulations were published in; Regulation (EU) 2017/745 replacing directive on AIMDD and MDD and Regulation (EU) 2017/746 (IVDR) replacing IVDD. Methods: European Union Directives and published articles were reviewed. This study helps to understand that how it affected patient safety, and impacting the SMEs, regulatory authorities, research and health care industry. Discussion: With the new rule-based risk classification, the NB oversight has been increased from 7 to 84%, and due to lack of approved EU reference lab and official guidance documents, maybe 22% of the test currently placed on the market will be lost to the transition. For the manufacturers, these changes resulted in recruiting more skilled resources, time-consuming processes and thereby translated to an increase in the cost of the final product. This leads to prioritization of their portfolio and will have a direct impact on the sector of innovation research, resulting in mergers and acquisitions of SME by big companies. On the other hand, due to the new stringent regulations, will trigger the introduction of smart, efficient, and environment-friendly technologies. There will be an increase in the scope of medical and regulatory affairs roles and the new regulation will ensure patient safety, device efficacy and product transparency.

Keywords: In-vitro Diagnostic (IVD), In-vitro Diagnostic Directive (IVDD), In-vitro Diagnostic Regulations (IVDR), active implantable medical devices directive (AIMDD), Directives, Notified Body (NB), EU, small and medium-sized enterprises (SME).


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