top of page
Glossary Term
Economic Operators (in EU MDR)
Definition
Economic Operators refer to the entities involved in the lifecycle and supply chain of medical devices within the European Union under the EU Medical Device Regulation (EU MDR) (Regulation (EU) 2017/745). They include manufacturers, authorized representatives, importers, and distributors, each with specific roles and responsibilities to ensure device compliance, traceability, and safety in the EU market.
Relevance to the MedTech Industry
Economic Operators collectively ensure that medical devices comply with EU MDR requirements throughout their lifecycle, from manufacturing and distribution to post-market activities. This framework establishes clear accountability and transparency across the supply chain, safeguarding patient safety and product quality.
Additional Information & Related Terms
bottom of page