Authorized representative (EC REP) for manufacturers of medical devices from outside the European Un

InnoVision Deutschland GmbH is authorized representative according to the regulation (EU) 2017/745 on medical devices.

Who needs an authorized representative (EC REP)

Medical device manufacturers with a registered office outside the European Union must appoint an authorized representative in the EU. A manufacturer with a registered office outside the Union ensures that his authorized representative has continuous access to the required technical documentation.

The manufacturer must provide the authorized representative with the following documents:

• EU Declaration of Conformity

• Copy of technical documentation

• Proof that a corresponding conformity assessment procedure has been carried out

Upon request, the authorized representative must make these documents available to the competent authority in the member state.

Other duties of the authorized representative (EC REP)

• Forwarding any requests from a Member State competent authority to the manufacturer

• Cooperation with the competent authorities in all preventive or corrective measures

• Notifying the manufacturer of complaints

• Termination of the mandate if the manufacturer breaches its obligations under Regulation (EU) 2017/745

• Registration as an actor in the European Database for Medical Devices (EUDAMED)

For which manufacturers does InnoVision Deutschland GmbH act as an authorized representative within the meaning of Regulation (EU) 2017/745?

• Exclusively for manufacturers of medical devices in the following risk classes: Class I and Class IIa according to Regulation (EU) 2017/745