| EU MDR Economic Operator |
For the medical device manufacturer it is important to understand the role of EU MDR economic operator .These operators are also referred with the acronym MAID. The role of economic operator is tied to legal liability so one should understand how they fit in economic operator framework.
Who are EU MDR economic operators?
Economic operator As per MDR / IVDR economic operator means a manufacturer, an authorised representative, an importer, a distributor or the person referred to in Articles 22(1) and 22(3). The entities which supplies goods, services in context of that market is termed as operator.
EU MDR Economic operators are considered as
- Manufacturer
- Authorised representative
- Importer
- Distributor
As per article 22 (1) the entity that combines the devices which are CE Certified and
- Devices that bear the CE marking
- IVD medical devices bearing CE marking (EU IVDR 2017/746)
- Compliant products used within a Medical Procedure or which presence on the pack is justified.
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