Regulatory Strategy and Market Access Challenges under EU IVDR 2017/746: A Case Study of Indian IVD Exporters of Rapid Diagnostic Kits
| dc.contributor.author | Shaikh, Adnan | |
| dc.date.accessioned | 2025-12-03T14:57:05Z | |
| dc.date.available | 2025-12-03T14:57:05Z | |
| dc.date.issued | 2025 | |
| dc.description.abstract | The introduction of the In Vitro Diagnostic Regulation (IVDR) is one of the most significant regulatory shifts, affecting the European diagnostics industry. The regulation aims to increase patient safety, reliability, and transparency, but with this has come very strict demands that have overwhelmed the preparedness of many organisations. Nevertheless, there is a scarcity of empirical studies focused on how firms manage the new demands and address them, especially in terms of resource allocation, impediments to compliance, and adaptation to strategic change. Therefore, this research was conducted to critically reflect upon the preparation of organisations to comply with the IVDR and their policy margins, as well as the policy implications of the regulation. It used mixed methods, which included both quantitative survey responses as well as qualitative interviews, analysed using qualitative content analysis. This integration offered not only statistical data, but also a deep contextual knowledge of the industry experiences. The results indicated that there are three main themes: regulatory barriers focused on Notified Body scarcity and vague guidance; organisational preparedness that linked to resource endowment, re-strategising QMS, and digitalisation; and perceived benefits linked to greater market credibility, quality assurance, and patient confidence. As per analysis, it was identified that even though larger firms were more resilient, SMEs were over-represented in being burdened, which causes the problem of innovation and diversity in the competitive market. Furthermore, this research recommended that increasing the capacity of Notified Bodies, harmonising the regulatory guidelines as well, and implementing SME-specific compliance facilitating measures to reduce regulatory burdens. They also include proactive organisational strategies such as the use of digital traceability tools and the rationalisation of portfolios that can be addressed by organisations in order to enhance preparedness. Using empirical findings and practical recommendations, this study can make a contribution both to the understanding of the academic field and the practice of regulation, with foundations for future additional research and adaptation to the industry | |
| dc.identifier.uri | https://hdl.handle.net/20.500.14136/278 | |
| dc.title | Regulatory Strategy and Market Access Challenges under EU IVDR 2017/746: A Case Study of Indian IVD Exporters of Rapid Diagnostic Kits | |
| dc.type | Thesis |