Impacts of European In Vitro Diagnostic Regulation (IVDR) - Global IVD Director, Global Diagnostics Company

A global director at a leading diagnostics company describes how IVDR has impacted the EU. Overall, they view it as a positive development for larger companies, as it brings order and regulation to the industry. However, they also note some negative impacts, particularly on smaller companies accustomed to CE certification. The increased costs and resource requirements associated with complying with IVDR are driving some small and medium-sized companies out of the EU market or towards new markets in Africa, LATAM, or MENA. Regarding changes within their organization, the director highlights that the development of kits now requires more data, manpower, and resources, significantly increasing the cost and time of development. Additionally, the need for third-party evaluation and the addition of new elements to their quality management system have led to increased expenses and infrastructure changes. The director also mentions the impact of IVDR on Laboratory Developed Tests (LDTs), as well as variations in the implementation and enforcement of IVDR across different EU countries.