What Is An Economic Operator?
The term economic operator refers to manufacturers, authorised representative, distributors and importers. The EU MDR provides greater legal clarity on the various roles and responsibilities, and distributors are included for the first time in the legislation. Although the manufacturer is ultimately responsible for ensuring that their medical device is compliant with the relevant legislation, the various economic operators each have a part of play in ensuring the safety and performance of the device throughout the supply chain. These obligations include proper storage and handling, traceability, reporting requirements and verification of aspects of compliance of the device with EU MDR including CE mark, declaration of conformity and IFU and labelling requirements, among others. Economic operators are also required to cooperate with the manufacturer / authorised representative and the Competent Authority in relation to corrective actions. This represents a significant strengthening of the regulatory process over the existing Directives in providing greater legal clarity to economic operators.Questions to Consider
- Are you an economic operator?
- Are you aware of your responsibilities under EU MDR?
- Do you have the resources and systems in place to fulfil your obligations under the new Regulations?