Framework
EUIVDR — Economic Operators
The EU IVDR 2017/746 defines the obligations of all economic operators in the IVD medical device supply chain, including manufacturers, authorized representatives, importers, and distributors. Each category of economic operator has specific responsibilities to ensure that only compliant IVD devices reach the market and that traceability and regulatory obligations are maintained throughout the distribution chain.
Overview
Background
Regulation (EU) 2017/746 introduced expanded obligations for economic operators in the IVD sector, mirroring the approach taken in the EU MDR for medical devices. The regulation established clear responsibilities for each link in the supply chain, addressing gaps identified under the previous IVD Directive where non-manufacturer obligations were poorly defined.
Applicability
These requirements apply to all entities involved in making IVD medical devices available on the EU market. Manufacturers bear primary responsibility for device compliance. Authorized representatives act on behalf of non-EU manufacturers. Importers must verify compliance before placing IVD devices on the market. Distributors must verify that devices they handle bear required markings and documentation.