Should I anticipate changes on my product specifications and performance post-IVDR?
No. Product specifications and performance are expected to remain the same. From a supply chain perspective, the transition to IVDR is expected to be transparent to our customers. Although IVDR requires additional elements related to the product’s Design History Files and the manufacturer’s Quality Management Systems, Beckman Coulter Life Sciences is confident that our current portfolio specifications and performance data will meet all new requirements.