Classification
Why Class I sterile, measuring and invasive devices cost more
2026-01-22 · 3 min read
Special Class I characteristics change the specialised state fee and the expected testing scope.
What Changed
Class I devices are not treated as a single group. Sterile, measuring and invasive characteristics attract a higher specialised state fee than ordinary Class I devices.
Who Is Affected
Manufacturers of sterile single-use products, devices with a measuring function, and invasive instruments classified as Class I.
What It Means
Budgeting a single Class I figure understates the government fee for these devices, and laboratory testing is more likely to be requested.
What Manufacturers Should Do
Declare the characteristics accurately at estimate stage so the government fee and testing assumptions in your project budget are correct from the start.
Source: REGVIA regulatory practice note