The MDR structures regulatory responsibility around four categories of economic operator: the manufacturer, the EC REP authorised representative, the importer and the distributor. Each has specific obligations defined by the Regulation. This structure is one of the major changes brought by the MDR compared with the directive — under Directive 93/42/EEC, the obligations of operators other than the manufacturer were barely formalised.
The hierarchy of responsibilities
The manufacturer bears the primary and heaviest responsibility. It is responsible for the conformity of the device throughout its life cycle. This responsibility does not transfer to the other operators, even when the manufacturer subcontracts design, manufacturing or distribution activities.
The EC REP authorised representative is the regulatory interface between the non-EU manufacturer and the European authorities. It assumes jointly with the manufacturer the obligations listed in Article 11(3). Its responsibility is shared with the manufacturer for these specific obligations.
The importer verifies the apparent conformity of the devices it imports and ensures the traceability of its part of the chain. Its responsibility is engaged if it has placed on the market a non-conforming device whose non-conformity it could have identified.
The distributor verifies the apparent conformity of the devices it distributes and ensures the traceability of its part of the chain. It is reclassified as a manufacturer if it modifies a device or rebrands it under its own brand.
The cases that blur the boundaries
In commercial practice, a single operator can perform several roles. A company that buys devices outside the EU and imports them for resale in Europe is both an importer (it places the device on the EU market for the first time) and a distributor (it makes it available downstream). Its obligations combine those of both roles.
A company that buys devices from an EU manufacturer and resells them under its own commercial brand without mentioning the original manufacturer is reclassified as a manufacturer. It must then assume the full set of MDR manufacturer obligations.
What this structure means for multi-function companies
Companies operating at several levels of the chain must clearly identify their role for each product family and put in place the corresponding procedures. A distributor that repackages certain products under its own brand and distributes others without modification must distinguish between the two activities within its organisation and its processes.