This lecture provides a qualitative and quantitative overview of the economic impact and challenges in achieving EU MDR / IVDR readiness within the Medtech industry at large. We take a critical look beyond the question of “How to meet technically regulatory requirements?”, which concerns governmental affairs functions of Medtech companies now.
Business leaders struggle to answer the essential strategic question: “What effects has the implementation of new EU MDR / IVDR regulations on the Medtech sector?”. The task at hand is for most companies overwhelming due to the lack of budgets, resources, know-how, and strategic guidance. Hence, this new policy is a severe challenge affecting business models strongly. Nevertheless, becoming EU MDR / IVDR compliant by 2020 is a “must” to business leaders and demand clear strategic actions. Our peer-reviewed risk assessment takes a broad view on this issue, including costs burden within product portfolios, resource requirements, margin impacts, etc.
The lecture is designed to provide an understanding of Medtech industry including governmental affairs staff and healthcare stakeholders regarding a timely EU MDR / IVDR readiness and covers the following:
- Crucial economic indications and challenges
- Specific challenges to the UK and non-EU companies regarding EU MDR / IVDR
- Critical qualitative and quantitative risk burden for the EU Medtech industry manufacturers
- Current pitfalls of management towards EU MDR / IVDR Readiness
- Potential intra-industry approach and out-of-box remedies