As the implementation date of In Vitro Diagnostic Regulation (IVDR) looms on May 26, 2022, significant uncertainty remains around the new regulatory system. Under Directive 98/79/EC around 10% of all IVDs placed on the market need notified body involvement, whereas under the IVDR this will rise to 80%-90%. Notified body shortages continue to be a major challenge for industry, with many manufacturers yet to receive certification. The situation is expected to be particularly problematic for SME manufacturers who will see most of their products blocked on the market if they don’t receive validation in time.