Make the strategic decision explicit
This July 2023 article addressed the IVDR transition as it was understood then. Its stated deadlines have historical context and are not current regulatory guidance. The enduring planning issue is whether a company intends to maintain each product’s market access and will commit the necessary resources.
Build an evidence-based execution plan
Assess technical documentation, risk management, performance evidence, labeling, registration data, and post-market needs. Identify missing studies early, since generating new evidence may determine the critical path.
Prioritize products according to strategic value and feasibility. Engage notified bodies, align internal specialists, and account for supply chain constraints. Establish executive sponsorship and a living plan with clear ownership. Compliance readiness is more than repackaging an existing submission; it requires a coordinated assessment of what evidence exists, what is missing, and how the organization will close the gaps.