Framework
EUMDR — Economic Operators
The EU MDR 2017/745 defines the obligations of all economic operators in the medical device supply chain, including manufacturers, authorized representatives, importers, and distributors. Each category of economic operator has specific responsibilities to ensure that only compliant devices reach the market and that traceability and regulatory obligations are maintained throughout the distribution chain.
Overview
Background
Regulation (EU) 2017/745 introduced significantly expanded obligations for all economic operators compared to the previous directives. The regulation established clear, legally binding responsibilities for each link in the supply chain, recognizing that device safety and regulatory compliance depend on coordinated efforts from all parties involved in making devices available on the EU market.
Applicability
These requirements apply to all entities involved in making 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 devices on the market. Distributors must verify that devices they handle bear required markings and are accompanied by required documentation.