Module22 March 20263 min read
Module spotlight: Economic Operators
EU regulation assigns duties to manufacturers, authorized reps, importers, and distributors. Economic operators keeps those roles and obligations clear.
By MoniDoseQMS Team
EU MDR does not just regulate devices — it assigns specific duties to the parties in the supply chain: manufacturers, authorized representatives, importers, and distributors. The economic operators module keeps those relationships and obligations clear.
What you can do
- Record the economic operators in your supply chain
- Track roles, responsibilities, and agreements
- Connect operators to registrations and EUDAMED
- Keep obligations clear across the chain
Why it matters
EU MDR (Articles 11-14) defines economic operator obligations. Keeping them documented avoids the gaps that appear when responsibilities are assumed rather than recorded.