As per the European Union Medical Device Regulation (EUMDR) 2017/745 Article 22(1) and 22(3), a manufacturer, an Authorized Representative (AR), an importer and a distributor are referred to as Economic Operators (EOs), with well-defined responsibilities to guard the safety of medical devices entering into the EU market. An Economic Operator can be a person or an organization, who are authoritative to take up the duty of ensuring compliance.
What is the role of an Economic Operator (EO)?
European Authorized Representative (EAR): EUDAMED registration, technical documentations, UDI labeling, Post-market Surveillance (PMS), Person Responsible for Regulatory Compliance (PRRC) and corrective actions.
Manufacturers: EUDAMED registration, technical documentation, development and assembly, handling, storage and distribution, corrective actions, UDI labeling, complaints, PMS and PRRC.
Importers: EUDAMED registration, handling, storage and distribution, corrective actions and PMS.
Distributors: Handling, storage and distribution, corrective actions, UDI labeling, complaints and PMS.
What are the Regulatory Obligations for an Economic Operator?
The following are the responsibilities of an Economic Operator:
- ARs, manufacturers and importers must register themselves with the EUDAMED. The manufacturers and ARs should maintain the conformity assessment
- Should possess all the technical documents required by the Agency
- Should co-operate in the investigations to get permanent access to the PRRC
- ARs are liable for the defective devices along with the manufacturer, if the manufacturer does not meet the Regulatory standards set by the Agency
- Manufacturer must provide the Declaration of Conformity (DOC) and Unique Device Identification (UDI) for each medical device to ensure the safety
- The importer must ensure the labeling activities like the device is CE-marked and UDI-assigned
- The distributor must share the customer complaints with the stake holders
- The distributor must assure that, the device shortage and transportation conditions are in compliance with the manufacturer
Are you willing to launch your medical devices in the EU market? Are you looking for an Economic Operator and would like to gain more insights on their roles and responsibilities? Reach out to regional Regulatory expert.