Glossary · EU medical devices: MDR

Economic operators (MDR and IVDR)

Also known as: Economic operator, Manufacturer, authorized representative, importer, distributor

Under the EU Medical Device Regulation (EU) 2017/745 and the IVD Regulation (EU) 2017/746, economic operators are the manufacturer, the authorized representative, the importer and the distributor. Each has its own obligations: manufacturer (Article 10), authorized representative (Article 11), importer (Article 13) and distributor (Article 14).

EU
MDR
IVDR

In one sentence

MDR and IVDR economic operators: manufacturer, authorized representative, importer and distributor, each with its own obligations in Articles 10 to 16.

Example

A US manufacturer of surgical staplers appoints an authorized representative in Ireland, ships through an importer in the Netherlands that checks CE marking, UDI and labeling, and sells via distributors who verify the devices before passing them on.

How it applies

Manufacturer: Carries the main obligations: quality management system, risk management, clinical evaluation or performance evaluation, technical documentation, UDI, post-market surveillance, vigilance and the declaration of conformity.
Authorized representative: Required when the manufacturer is established outside the EU. Acts on its behalf toward authorities under a written mandate and is jointly and severally liable with the manufacturer for defective devices.
Importer and distributor: Verify before placing on the market or making available that the device bears the CE marking, has a declaration of conformity, is correctly labeled and has a UDI where required. They report suspected nonconformities and cooperate on corrective actions.
Taking on manufacturer duties: Under Article 16, an importer, distributor or other person who places a device on the market under its own name, changes its intended purpose or modifies it in a way that may affect compliance takes on the obligations of a manufacturer. Some activities, such as translation of information or repackaging under conditions, don’t trigger this.
Registration: Manufacturers, authorized representatives and importers register in EUDAMED and receive a single registration number (SRN).
Technical documentation: Each role needs records that show it met its verification duties, for example importer checks, complaint logs and the mandate between manufacturer and authorized representative.

Manufacturer vs. authorized representative

The manufacturer is responsible for the device; the authorized representative is its legal presence in the EU. The authorized representative keeps the technical documentation and declaration of conformity available to authorities and must have access to a PRRC, but it does not design, produce or certify the device.